<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03802045</url>
  </required_header>
  <id_info>
    <org_study_id>USaoPauloSA</org_study_id>
    <nct_id>NCT03802045</nct_id>
  </id_info>
  <brief_title>Electroacupuncture Frequency-related Effects on Non-specific Low Back Pain in Older Adults.</brief_title>
  <official_title>Electroacupuncture Frequency-related Effects on Chronic Low Back Pain in Older Adults: Triple-blind, 12-month Protocol for a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Low back pain (LBP) is the most frequent complaint in the clinical practice.&#xD;
      Electroacupuncture treatment may be effective, however, the evidence supporting this&#xD;
      possibility is still limited, especially in older adults.&#xD;
&#xD;
      Methods: A five-arm randomized controlled trial with patients and evaluators blinded to the&#xD;
      group allocation. A total of 125 participants with non-specific low back pain will be&#xD;
      randomly assigned into one of five groups: three electroacupuncture groups (low, high and&#xD;
      alternating frequency), a control and a placebo group. The electroacupuncture will be applied&#xD;
      twice a week (30 minutes per session) for 5 weeks. The primary clinical outcome will be pain&#xD;
      intensity. The secondary outcomes include: quality of pain, physical functioning, perceived&#xD;
      overall effect, emotional functionality, patient satisfaction and psychosocial factors.&#xD;
      Patients will be evaluated before the first session, immediately after the last, and&#xD;
      followed-up after 6 and 12 months to check the effects in the medium and long term.&#xD;
&#xD;
      Discussion: Results of this trial will help clarify the therapeutic effect of different&#xD;
      frequencies of electroacupuncture for chronic low back pain in older adults and to determine&#xD;
      the most effective electroacupuncture frequency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a randomized controlled clinical trial with blind evaluators and patients.&#xD;
      The study will be conducted at the University of São Paulo (USP), approved by the Research&#xD;
      Ethics Committee of the Medical School of USP (authorization No. 2.903.991) and financed with&#xD;
      its own resources.&#xD;
&#xD;
      Participants will be recruited through radio ads, social networks and local newspapers.&#xD;
      Individuals will be informed about the research proposal and treatment protocol, and those&#xD;
      that are interested in participating will be selected according to the inclusion and&#xD;
      exclusion criteria.&#xD;
&#xD;
      Patients will be eligible for inclusion if they are over 60 years of age, of either gender,&#xD;
      with diagnosis of nonspecific LBP of more than 3 months duration, with or without radiating&#xD;
      leg pain, with a minimum pain intensity score of 4 on the 11-point pain numerical rating&#xD;
      scale (NRS - Brazilian Portuguese version), that can walk independently (with or without&#xD;
      walking devices) and that agree to voluntarily participate in this study and sign the consent&#xD;
      form.&#xD;
&#xD;
      Patients will be excluded if they have had previous surgery on the spinal column, have a&#xD;
      known or suspected serious spinal pathology (e.g., cancer, vertebral fracture, spinal&#xD;
      infection or cauda equina syndrome), a fear of needles, have participated in acupuncture&#xD;
      treatment in the previous 30 days, if they are wheelchair users, or if they are unable to&#xD;
      sign the consent form.&#xD;
&#xD;
      The protocol of this study is based on standards established under the Standards for&#xD;
      Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) and the Initiative on&#xD;
      Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).&#xD;
&#xD;
      Prior to the first treatment session, the random allocation sequence will be implemented by a&#xD;
      researcher not involved in the patient recruitment or evaluation, and will be generated&#xD;
      through the randomization.com program, where each number will match one of five study groups.&#xD;
&#xD;
      After the numbers are generated, they will be placed in sealed, brown envelopes and numbered&#xD;
      in series, then given to the acupuncturist. This person will open them according to the&#xD;
      numerical sequence, prior to the first session.&#xD;
&#xD;
      Patients will remain blind regarding the category of their allocation throughout the data&#xD;
      collection period of the study. Additionally, the evaluators responsible for the data&#xD;
      collection will be blinded to the patient allocation. The acupuncturist, being responsible&#xD;
      for the interventions, will be the only person not blind to the type of treatment to be&#xD;
      performed.&#xD;
&#xD;
      The interventions will be performed by acupuncture specialists with at least 3 years of&#xD;
      clinical experience, who will receive prior training to ensure that they rigorously follow&#xD;
      the study protocol and are familiar with the types of treatments, including details such as&#xD;
      acupuncture points and manipulation of electroacupuncture parameters.&#xD;
&#xD;
      Outcome measures Four stages of evaluations will be performed: prior to the start of&#xD;
      treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the&#xD;
      final treatment. The evaluators will be trained in advance.&#xD;
&#xD;
      The primary clinical outcome will be pain intensity. The secondary outcomes will include&#xD;
      quality of pain, physical functioning, perception of overall effect, emotional functionality,&#xD;
      patient satisfaction and psychosocial factors. All the scales and questionnaires have been&#xD;
      translated into Brazilian Portuguese, with the exception of the visual analog scale for the&#xD;
      assessment of anxiety, and their properties clinimetrically tested.&#xD;
&#xD;
      Primary outcomes Pain intensity Numerical Rating Scale (NRS) The NRS is an 11-point scale&#xD;
      ranging from 0 (no pain) to 10 (worst possible pain). Participants will be asked to rate&#xD;
      their average pain levels in the 24 hours prior to the assessment.&#xD;
&#xD;
      Pressure pain threshold (PPT) The pressure pain threshold (PPT) will be measured using a&#xD;
      pressure algometer (EMG system, Brazil). The assessed region will be marked with a tape&#xD;
      measure and a dermatographic pencil. Two points will be marked bilaterally: 5 cm to the right&#xD;
      and left of the spinous process of L3 and L5. A control point will be marked on the anterior&#xD;
      tibial muscle of the right leg, 5 cm lateral to the tuberosity of the tibia. The circular tip&#xD;
      of the algometer will be positioned perpendicular to the participant's skin and gradually&#xD;
      pressed until the participant reports that the pressure has become painful and unbearable.&#xD;
      Three measurements will be taken at each point with an interval of 1 minute. At the end, the&#xD;
      arithmetic mean will be used to define the pressure pain threshold. To ensure data&#xD;
      reliability, a preliminary intra-observer study will be conducted to measure the pressure&#xD;
      pain threshold at the assessment points that will be used in the study. In this, 10&#xD;
      participants will be evaluated and reassessed by the same examiner, with a 48-hour interval.&#xD;
      The intraclass correlation coefficient (ICC) will be calculated by the measurements of the&#xD;
      PPT of the anterior tibial and the lumbar points.&#xD;
&#xD;
      Secondary outcomes Quality of pain This will be analyzed using the McGill Pain Questionnaire,&#xD;
      a valid and reliable instrument containing 78 pain descriptors divided into 4 categories&#xD;
      (sensory, affective, evaluative and miscellaneous) and 20 subcategories, to which scores of 1&#xD;
      to 5 are attributed. The result is obtained by first scoring the words according to their&#xD;
      position within the set of descriptors of each subcategory. The maximum score in the sensory&#xD;
      category is 42, in the affective 14, in the evaluative 5 and in the miscellaneous 17. Then,&#xD;
      the analysis is performed by adding these values associated with their categories. Higher&#xD;
      scores equate to more intense pain. Physical functioning This measure will be assessed&#xD;
      through the Roland Morris Disability Questionnaire and the Five Times Sit to Stand Test&#xD;
      (FTSST).&#xD;
&#xD;
      The first is a self-administered questionnaire, adapted to the Portuguese language, which&#xD;
      aims to evaluate physical incapacity due to low back pain. This contains 24 items pertaining&#xD;
      to activities that can be impaired due to LBP. Individuals need to select the items that&#xD;
      apply to their pain on that day. The selected items are summed for a total score ranging from&#xD;
      0 to 24, with higher scores indicating more severe functional incapacity. The activity of&#xD;
      sitting and standing is a common and important movement in daily life, and in the clinical&#xD;
      practice it helps to determine a person's functional level. The patient initiates the FTSST&#xD;
      sitting in a chair without arm support, with the upper limbs crossed over the chest, feet&#xD;
      positioned at hip width and knees in 90° flexion. They will be asked to stand and sit five&#xD;
      times as fast as possible. A timer will be used to measure the task execution time. The test&#xD;
      will be performed twice and the mean time will be calculated.&#xD;
&#xD;
      Perceived overall effect The patient's self-perception regarding the treatment will be&#xD;
      evaluated using the Global Effect Perception Scale, a 11-point numerical scale ranging from&#xD;
      -5 (much worse) to +5 (much better), where higher scores represent better recovery.(18)&#xD;
      Emotional functionality Depression and anxiety will be assessed using the Beck Depression&#xD;
      Inventory (BDI) and the Global Anxiety - Visual Analog Scale (GA-VAS), respectively.&#xD;
&#xD;
      The BDI is a self-administered questionnaire that contains 21 items, with a score ranging&#xD;
      from 0 to 3, where a higher score indicates more depressive symptoms. The GA-VAS is composed&#xD;
      of a 100mm line, where the left extremity is related to the absence of anxiety, and the right&#xD;
      extremity is related to the worst possible anxiety. The individual is asked to assess the&#xD;
      intensity of their anxiety in the previous 24 hours and to mark this on the line. The&#xD;
      distance from the left edge of the line to the mark placed by the patient is measured in&#xD;
      millimeters. Greater measurements indicate greater anxiety.&#xD;
&#xD;
      Patient satisfaction The evaluation of the patient's satisfaction with the treatment will be&#xD;
      carried out using the MedRisk questionnaire of patient satisfaction with physiotherapeutic&#xD;
      care. This questionnaire contains 20 items, covering global aspects of the treatment (2&#xD;
      items), aspects related to the service provided (8 items), and aspects about the&#xD;
      therapist-patient relationship (10 items). Following a Likert-type scale, the patient's&#xD;
      response will range from 1 (strongly disagree) to 5 (strongly agree), where higher scores&#xD;
      represent greater satisfaction with the treatment.&#xD;
&#xD;
      Psychosocial factors The risk of a poor prognosis due to psychosocial factors will be&#xD;
      assessed using the STarT Back Screening Tool (SBST), a self-administered questionnaire with 9&#xD;
      items (4 related to referred pain and 5 related to psychosocial factors) where the patient&#xD;
      has the response options &quot;I agree&quot; (1 point) and &quot;I Disagree&quot; (zero points) in the first&#xD;
      eight items, and &quot;Nothing&quot;, &quot;A little&quot; or &quot;Moderate&quot; (zero points each), &quot;A lot&quot; or&#xD;
      &quot;Extremely&quot; (one point each) in the ninth item. If the total score is between 0-3 points, the&#xD;
      patient is classified as low risk for poor prognosis. When the total score is greater than 3&#xD;
      points the score of the psychosocial subscale, questions 5 to 9, is then considered. If the&#xD;
      score of this subscale is less than or equal to 3 points, the patient is classified as medium&#xD;
      risk and scores greater than 3 points are considered to indicate a high risk for poor&#xD;
      prognosis. Procedures After the randomization, the acupuncturist will sequentially open the&#xD;
      envelopes, and the individuals will be randomly assigned to one of five treatment groups: Low&#xD;
      frequency EA (LF), high frequency EA (HF), alternating frequency EA (AF), control group (C)&#xD;
      and placebo group (P), each containing 25 participants. The acupuncture points will be&#xD;
      located and described according to the WHO Standard Acupuncture Locations. Based on the&#xD;
      beneficial effects of previous clinical trials, the acupoints selected for this study will&#xD;
      be: BL23, BL25, BL40, SP6 and KI3.&#xD;
&#xD;
      Interventions Participants of the LF, HF and AF groups will be submitted to the treatment&#xD;
      protocol, which will consist of the bilateral application of electroacupuncture using a&#xD;
      previously calibrated electrostimulator (Sikuro DS100C), consisted of alternating symmetrical&#xD;
      biphasic waves with continuous pulse train for the low (2Hz) or high (100Hz) frequency&#xD;
      groups, and a mixed pulse train for the alternating frequency group (100Hz and 2Hz for 3&#xD;
      seconds each); 100ms pulse duration and 0.5ms pulse width; and the maximum current&#xD;
      (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is&#xD;
      avoided. Trichotomy will be carried out when necessary and the skin will be disinfected with&#xD;
      70% alcohol. With the participant lying down in a ventral position, the needles will be&#xD;
      inserted at a 90º inclination with the skin, to a depth at which that the patient reports the&#xD;
      &quot;deQi&quot; sensation (≅ 1.5cm).&#xD;
&#xD;
      The individuals that are randomly assigned to the C and P groups will follow exactly the same&#xD;
      protocol as the electroacupuncture groups, however the C group will not undergo electrical&#xD;
      stimulation, as the acupuncturist will activate channels that are not connected to the&#xD;
      patient. In the P group an adhesive moxa (Dong Yang®) will be placed on each acupoint and the&#xD;
      needle will be inserted over it, so that the participant only feels the needle prick, but&#xD;
      without perforation of the skin and the &quot;deQi&quot; sensation. In addition, as in group C, the&#xD;
      electrodes will be connected to the needles, however, no electrical current will be applied.&#xD;
      Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc.,&#xD;
      Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks,&#xD;
      totaling 10 sessions.&#xD;
&#xD;
      Sample size calculation The sample calculation was defined assuming a two-point difference in&#xD;
      pain intensity through the Numerical Pain Scale, with an estimated standard deviation of 1.47&#xD;
      points. Considering a test power of 80%, a significance level of 5% and a sample loss of 20%,&#xD;
      25 participants will be recruited for each group (125 in total). (G * Power 3 3.1. 9.2).&#xD;
&#xD;
      Statistical analysis The statistical analysis will be performed according to the&#xD;
      intention-to-treat principle. An analysis of variance (ANOVA) will be used to examine the&#xD;
      effect of the treatment, time (pre- and post-treatment, 6 and 12 months follow up), and the&#xD;
      interaction between groups versus time. If differences between the groups are identified,&#xD;
      Tukey's multiple comparison test will be conducted. Two-sided paired t-tests will use for&#xD;
      within-group comparisons (comparing baseline to follow up). The non-parametric statistical&#xD;
      test (Kruskal Wallis) will be used if the data is not normally distributed. All statistical&#xD;
      analyses will be conducted using SPSS (IBM Co, Armonk, New York, USA) for Windows, V.19.0.&#xD;
      The confidence interval will be established at 95%, and the significance level will be set at&#xD;
      5%.&#xD;
&#xD;
      Safety At each treatment session the participants will be asked about any unpleasant and&#xD;
      unintended signs or symptoms associated with the use of electroacupuncture. A questionnaire&#xD;
      will also be used with a record of the duration and intensity of the adverse symptom reported&#xD;
      by the patient, which will be scored according to a Likert-type scale from 1 to 5, with 1&#xD;
      representing the absence of adverse symptoms and 5 severe adverse symptoms.&#xD;
&#xD;
      Ethics and data security All the patients will participate voluntarily and will sign a&#xD;
      consent form prior to the randomization. The access and storage of the data will be in&#xD;
      accordance with the guidelines of the National Research Ethics Commission (CONEP). This study&#xD;
      has been approved by the Ethics Committee of the University of São Paulo Medical School&#xD;
      (authorization No. 2.903.991) and is registered in Plataforma Brasil (CAAE:&#xD;
      89846118.7.0000.0065).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">May 1, 2019</start_date>
  <completion_date type="Anticipated">December 17, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 18, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The individuals will be randomly assigned to one of five treatment groups: Low frequency EA (LF) with 2Hz, high frequency EA (HF) with 100Hz, alternating frequency EA (AF) with 2 and 100Hz for 3 seconds each, control group (C) and placebo group (P), each containing 25 participants. The LF, HF and AF groups will be submitted to the treatment protocol, which will consist of the bilateral application of electroacupuncture using NKL® portable electrostimulator. The C and P groups will follow exactly the same protocol as the electroacupuncture groups, however the C group will not undergo electrical stimulation, as the acupuncturist will activate channels that are not connected to the patient. In the P group an adhesive moxa will be placed on each acupoint and the needle will be inserted over it. In addition, as in group C, the electrodes will be connected to the needles, however, no electrical current will be applied.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Prior to the first treatment session, the random allocation sequence will be implemented by a researcher not involved in the patient recruitment or evaluation, and will be generated through the randomization.com program, where each number will match one of five study groups.&#xD;
After the numbers are generated, they will be placed in sealed, brown envelopes and numbered in series, then given to the acupuncturist. This person will open them according to the numerical sequence, prior to the first session.&#xD;
Patients will remain blind regarding the category of their allocation throughout the data collection period of the study. Additionally, the evaluators responsible for the data collection and the outcomes assessor will be blinded to the patient allocation. The acupuncturist, being responsible for the interventions, will be the only person not blind to the type of treatment to be performed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity - Numerical Rating Scale (NRS)</measure>
    <time_frame>prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment</time_frame>
    <description>Will be measure using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Participants will be asked to rate their average pain levels in the 24 hours prior to the assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain intensity - Pressure pain threshold (PPT)</measure>
    <time_frame>prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment</time_frame>
    <description>The PPT will be measured using a pressure algometer (EMG system, Brazil). The assessed region will be marked with a tape measure and a dermatographic pencil. Two points will be marked bilaterally: 5 cm to the right and left of the spinous process of L3 and L5. A control point will be marked on the anterior tibial muscle of the right leg, 5 cm lateral to the tuberosity of the tibia. The circular tip of the algometer will be positioned perpendicular to the participant's skin and gradually pressed until the participant reports that the pressure has become painful and unbearable. Three measurements will be taken at each point with an interval of 1 minute.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of pain</measure>
    <time_frame>prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment</time_frame>
    <description>This will be analyzed using the McGill Pain Questionnaire, a valid and reliable instrument containing 78 pain descriptors divided into 4 categories (sensory, affective, evaluative and miscellaneous) and 20 subcategories, to which scores of 1 to 5 are attributed. The result is obtained by first scoring the words according to their position within the set of descriptors of each subcategory. The maximum score in the sensory category is 42, in the affective 14, in the evaluative 5 and in the miscellaneous 17. Then, the analysis is performed by adding these values associated with their categories. Higher scores equate to more intense pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived overall effect</measure>
    <time_frame>prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment</time_frame>
    <description>The patient's self-perception regarding the treatment will be evaluated using the Global Effect Perception Scale, a 11-point numerical scale ranging from -5 (much worse) to +5 (much better), where higher scores represent better recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional functionality - Depression</measure>
    <time_frame>prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment</time_frame>
    <description>Depression will be assessed using the Beck Depression Inventory (BDI), a self-administered questionnaire that contains 21 items, with a score ranging from 0 to 3, where a higher score indicates more depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment</time_frame>
    <description>The evaluation of the patient's satisfaction with the treatment will be carried out using the MedRisk questionnaire of patient satisfaction with physiotherapeutic care. This questionnaire contains 20 items, covering global aspects of the treatment (2 items), aspects related to the service provided (8 items), and aspects about the therapist-patient relationship (10 items). Following a Likert-type scale, the patient's response will range from 1 (strongly disagree) to 5 (strongly agree), where higher scores represent greater satisfaction with the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial factors</measure>
    <time_frame>prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment</time_frame>
    <description>The risk of a poor prognosis due to psychosocial factors will be assessed using the STarT Back Screening Tool (SBST), a self-administered questionnaire with 9 items (4 related to referred pain and 5 related to psychosocial factors) where the patient has the response options &quot;I agree&quot; (1 point) and &quot;I Disagree&quot; (zero points) in the first eight items, and &quot;Nothing&quot;, &quot;A little&quot; or &quot;Moderate&quot; (zero points each), &quot;A lot&quot; or &quot;Extremely&quot; (one point each) in the ninth item. If the total score is between 0-3 points, the patient is classified as low risk for poor prognosis. When the total score is greater than 3 points the score of the psychosocial subscale, questions 5 to 9, is then considered. If the score of this subscale is less than or equal to 3 points, the patient is classified as medium risk and scores greater than 3 points are considered to indicate a high risk for poor prognosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functioning - Roland Morris Disability Questionnaire</measure>
    <time_frame>prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment</time_frame>
    <description>This measure will be assessed through the Roland Morris Disability Questionnaire. This is a self-administered questionnaire, adapted to the Portuguese language, which aims to evaluate physical incapacity due to low back pain. This contains 24 items pertaining to activities that can be impaired due to LBP. Individuals need to select the items that apply to their pain on that day. The selected items are summed for a total score ranging from 0 to 24, with higher scores indicating more severe functional incapacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional functionality - Anxiety</measure>
    <time_frame>prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment</time_frame>
    <description>Anxiety will be assessed using the Global Anxiety - Visual Analog Scale (GA-VAS). This is composed of a 100mm line, where the left extremity is related to the absence of anxiety, and the right extremity is related to the worst possible anxiety. The individual is asked to assess the intensity of their anxiety in the previous 24 hours and to mark this on the line. The distance from the left edge of the line to the mark placed by the patient is measured in millimeters. Greater measurements indicate greater anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functioning - Five Times Sit to Stand Test</measure>
    <time_frame>prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment</time_frame>
    <description>This measure will be assessed through the Five Times Sit to Stand Test (FTSST). The patient initiates the FTSST sitting in a chair without arm support, with the upper limbs crossed over the chest, feet positioned at hip width and knees in 90° flexion. They will be asked to stand and sit five times as fast as possible. A timer will be used to measure the task execution time. The test will be performed twice and the mean time will be calculated.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Low frequency EA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 participants will receive bilateral application of electroacupuncture using a previously calibrated EL 608 electrostimulator (NKL® portable), with the following parameters: balanced asymmetrical biphasic polarized pulse with continuous pulse train with 2Hz; 100ms pulse duration and 0.5ms pulse width; and the maximum current (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is avoided. Trichotomy will be carried out when necessary and the skin will be disinfected with 70% alcohol. With the participant lying down in a ventral position, the needles will be inserted at a 90º inclination with the skin, to a depth at which that the patient reports the &quot;deQi&quot; sensation (≅ 1.5cm).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High frequency EA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 participants will receive 25 participants will receive bilateral application of electroacupuncture using a previously calibrated EL 608 electrostimulator (NKL® portable), with the following parameters: balanced asymmetrical biphasic polarized pulse with continuous pulse train with 100Hz; 100ms pulse duration and 0.5ms pulse width; and the maximum current (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is avoided. Trichotomy will be carried out when necessary and the skin will be disinfected with 70% alcohol. With the participant lying down in a ventral position, the needles will be inserted at a 90º inclination with the skin, to a depth at which that the patient reports the &quot;deQi&quot; sensation (≅ 1.5cm).&#xD;
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alternating frequency EA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 participants will receive 25 participants will receive bilateral application of electroacupuncture using a previously calibrated EL 608 electrostimulator (NKL® portable), with the following parameters: balanced asymmetrical biphasic polarized pulse with continuous pulse train with 100Hz and 2Hz for 3 seconds each; 100ms pulse duration and 0.5ms pulse width; and the maximum current (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is avoided. Trichotomy will be carried out when necessary and the skin will be disinfected with 70% alcohol. With the participant lying down in a ventral position, the needles will be inserted at a 90º inclination with the skin, to a depth at which that the patient reports the &quot;deQi&quot; sensation (≅ 1.5cm).&#xD;
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 participants will follow exactly the same protocol as the experimental groups, however they will not undergo electrical stimulation, as the acupuncturist will activate channels that are not connected to the patient.&#xD;
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>25 participants will will follow exactly the same protocol as the experimental groups, however an adhesive moxa (Dong Yang®) will be placed on each acupoint and the needle will be inserted over it, so that the participant only feels the needle prick, but without perforation of the skin and the &quot;deQi&quot; sensation. In addition, as in the control group, the electrodes will be connected to the needles, however, no electrical current will be applied.&#xD;
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <description>The interventions will be performed by acupuncture specialists with at least 3 years of clinical experience, who will receive prior training to ensure that they rigorously follow the study protocol and are familiar with the types of treatments, including details such as acupuncture points and manipulation of electroacupuncture parameters.&#xD;
After the randomization, the acupuncturist will sequentially open the envelopes, and the individuals will be randomly assigned to one of five treatment groups: Low frequency EA (LF), high frequency EA (HF), alternating frequency EA (AF), control group (C) and placebo group (P), each containing 25 participants. The acupuncture points will be located and described according to the WHO Standard Acupuncture Locations. Based on the beneficial effects of previous clinical trials, the acupoints selected for this study will be: BL23, BL25, BL40, SP6 and KI3.</description>
    <arm_group_label>Alternating frequency EA</arm_group_label>
    <arm_group_label>High frequency EA</arm_group_label>
    <arm_group_label>Low frequency EA</arm_group_label>
    <other_name>Acupuncture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Needle</intervention_name>
    <description>Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used.</description>
    <arm_group_label>Alternating frequency EA</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>High frequency EA</arm_group_label>
    <arm_group_label>Low frequency EA</arm_group_label>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adhesive Moxa</intervention_name>
    <description>In the placebo group an adhesive moxa will be placed on each acupoint and the needle will be inserted over it.</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 60 years of age&#xD;
&#xD;
          -  Either gender&#xD;
&#xD;
          -  Diagnosis of nonspecific low back pain of more than 3 months duration, with or without&#xD;
             radiating leg pain, with a minimum pain intensity score of 4 on the 11-point pain&#xD;
             numerical rating scale (NRS - Brazilian Portuguese version)&#xD;
&#xD;
          -  Walk independently (with or without walking devices)&#xD;
&#xD;
          -  Agree to voluntarily participate in this study and sign the consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous surgery on the spinal column&#xD;
&#xD;
          -  Have a known or suspected serious spinal pathology (e.g., cancer, vertebral fracture,&#xD;
             spinal infection or cauda equina syndrome)&#xD;
&#xD;
          -  Fear of needles&#xD;
&#xD;
          -  Have participated in acupuncture treatment in the previous 30 days&#xD;
&#xD;
          -  Wheelchair users.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sarina F Torres, Master´s</last_name>
    <phone>41985120128</phone>
    <phone_ext>55</phone_ext>
    <email>sarinaftorres@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amélia P Marques, PhD</last_name>
    <phone>113893-4401</phone>
    <phone_ext>55</phone_ext>
    <email>pasqual@usp.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Federal University of Parana</name>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <zip>82590-300</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarina F Torres, Master´s</last_name>
      <phone>41985120128</phone>
      <phone_ext>55</phone_ext>
      <email>sarinaftorres@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ana Carolina B de Macedo, PhD</last_name>
      <phone>4199944080</phone>
      <phone_ext>55</phone_ext>
      <email>acbrandtmacedo@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University of Sao Paulo General Hospital</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>05402000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarina F Torres, Master´s</last_name>
      <phone>41985120128</phone>
      <phone_ext>55</phone_ext>
      <email>sarinaftorres@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Amélia P Marques, PhD</last_name>
      <phone>113893-4401</phone>
      <phone_ext>55</phone_ext>
      <email>pasqual@usp.br</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Malta DC, Oliveira MM, Andrade SSCA, Caiaffa WT, Souza MFM, Bernal RTI. Factors associated with chronic back pain in adults in Brazil. Rev Saude Publica. 2017 Jun 1;51(suppl 1):9s. doi: 10.1590/S1518-8787.2017051000052.</citation>
    <PMID>28591350</PMID>
  </reference>
  <reference>
    <citation>Wong AYL, Karppinen J, Samartzis D. Low back pain in older adults: risk factors, management options and future directions. Scoliosis Spinal Disord. 2017 Apr 18;12:14. doi: 10.1186/s13013-017-0121-3. eCollection 2017.</citation>
    <PMID>28435906</PMID>
  </reference>
  <reference>
    <citation>Robinson HS, Dagfinrud H. Reliability and screening ability of the StarT Back screening tool in patients with low back pain in physiotherapy practice, a cohort study. BMC Musculoskelet Disord. 2017 May 31;18(1):232. doi: 10.1186/s12891-017-1553-x.</citation>
    <PMID>28569152</PMID>
  </reference>
  <reference>
    <citation>Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.</citation>
    <PMID>28192789</PMID>
  </reference>
  <reference>
    <citation>Chou R, Deyo R, Friedly J, Skelly A, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S. Systemic Pharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):480-492. doi: 10.7326/M16-2458. Epub 2017 Feb 14.</citation>
    <PMID>28192790</PMID>
  </reference>
  <reference>
    <citation>Langevin HM, Schnyer R, MacPherson H, Davis R, Harris RE, Napadow V, Wayne PM, Milley RJ, Lao L, Stener-Victorin E, Kong JT, Hammerschlag R; Executive Board of the Society for Acupuncture Research. Manual and electrical needle stimulation in acupuncture research: pitfalls and challenges of heterogeneity. J Altern Complement Med. 2015 Mar;21(3):113-28. doi: 10.1089/acm.2014.0186. Epub 2015 Feb 24.</citation>
    <PMID>25710206</PMID>
  </reference>
  <reference>
    <citation>Comachio J, Oliveira Magalhaes M, Nogueira Burke T, Vidal Ramos LA, Peixoto Leao Almeida G, Silva AP, Ferreira de Meneses SR, Costa-Frutuoso JR, Santos Miotto Amorim C, Pasqual Marques A. Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial. Trials. 2015 Oct 15;16:469. doi: 10.1186/s13063-015-0850-7.</citation>
    <PMID>26472590</PMID>
  </reference>
  <reference>
    <citation>Liu L, Skinner M, McDonough S, Mabire L, Baxter GD. Acupuncture for low back pain: an overview of systematic reviews. Evid Based Complement Alternat Med. 2015;2015:328196. doi: 10.1155/2015/328196. Epub 2015 Mar 4.</citation>
    <PMID>25821485</PMID>
  </reference>
  <reference>
    <citation>MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010 Jun 8;7(6):e1000261. doi: 10.1371/journal.pmed.1000261.</citation>
    <PMID>20543992</PMID>
  </reference>
  <reference>
    <citation>Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.</citation>
    <PMID>15621359</PMID>
  </reference>
  <reference>
    <citation>Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe.</citation>
    <PMID>18923324</PMID>
  </reference>
  <reference>
    <citation>Nusbaum L, Natour J, Ferraz MB, Goldenberg J. Translation, adaptation and validation of the Roland-Morris questionnaire--Brazil Roland-Morris. Braz J Med Biol Res. 2001 Feb;34(2):203-10. doi: 10.1590/s0100-879x2001000200007.</citation>
    <PMID>11175495</PMID>
  </reference>
  <reference>
    <citation>Menezes Costa Lda C, Maher CG, McAuley JH, Hancock MJ, de Melo Oliveira W, Azevedo DC, Freitas Pozzi LM, Pereira AR, Costa LO. The Brazilian-Portuguese versions of the McGill Pain Questionnaire were reproducible, valid, and responsive in patients with musculoskeletal pain. J Clin Epidemiol. 2011 Aug;64(8):903-12. doi: 10.1016/j.jclinepi.2010.12.009. Epub 2011 Mar 27.</citation>
    <PMID>21444194</PMID>
  </reference>
  <reference>
    <citation>Gomes-Oliveira MH, Gorenstein C, Lotufo Neto F, Andrade LH, Wang YP. Validation of the Brazilian Portuguese version of the Beck Depression Inventory-II in a community sample. Braz J Psychiatry. 2012 Dec;34(4):389-94. doi: 10.1016/j.rbp.2012.03.005.</citation>
    <PMID>23429809</PMID>
  </reference>
  <reference>
    <citation>de Fatima Costa Oliveira N, Oliveira Pena Costa L, Nelson R, Maher CG, Beattie PF, de Bie R, Oliveira W, Camara Azevedo D, da Cunha Menezes Costa L. Measurement properties of the Brazilian Portuguese version of the MedRisk instrument for measuring patient satisfaction with physical therapy care. J Orthop Sports Phys Ther. 2014 Nov;44(11):879-89. doi: 10.2519/jospt.2014.5150.</citation>
    <PMID>25361861</PMID>
  </reference>
  <reference>
    <citation>Pilz B, Vasconcelos RA, Marcondes FB, Lodovichi SS, Mello W, Grossi DB. The Brazilian version of STarT Back Screening Tool - translation, cross-cultural adaptation and reliability. Braz J Phys Ther. 2014 Sep-Oct;18(5):453-61. doi: 10.1590/bjpt-rbf.2014.0028. Epub 2014 Aug 29.</citation>
    <PMID>25372008</PMID>
  </reference>
  <reference>
    <citation>Varoli FK, Pedrazzi V. Adapted version of the McGill Pain Questionnaire to Brazilian Portuguese. Braz Dent J. 2006;17(4):328-35. doi: 10.1590/s0103-64402006000400012.</citation>
    <PMID>17262148</PMID>
  </reference>
  <reference>
    <citation>Kahraman T, Ozcan Kahraman B, Salik Sengul Y, Kalemci O. Assessment of sit-to-stand movement in nonspecific low back pain: a comparison study for psychometric properties of field-based and laboratory-based methods. Int J Rehabil Res. 2016 Jun;39(2):165-70. doi: 10.1097/MRR.0000000000000164.</citation>
    <PMID>27031182</PMID>
  </reference>
  <reference>
    <citation>Gorenstein C, Andrade L, Vieira Filho AH, Tung TC, Artes R. Psychometric properties of the Portuguese version of the Beck Depression Inventory on Brazilian college students. J Clin Psychol. 1999 May;55(5):553-62. doi: 10.1002/(sici)1097-4679(199905)55:53.0.co;2-d.</citation>
    <PMID>10392786</PMID>
  </reference>
  <reference>
    <citation>Williams VS, Morlock RJ, Feltner D. Psychometric evaluation of a visual analog scale for the assessment of anxiety. Health Qual Life Outcomes. 2010 Jun 8;8:57. doi: 10.1186/1477-7525-8-57.</citation>
    <PMID>20529361</PMID>
  </reference>
  <reference>
    <citation>WHO standard acupuncture point locations in the Western Pacific Region. Manila, Philippines. 2009:1-242.</citation>
  </reference>
  <reference>
    <citation>Liu L, Skinner MA, McDonough SM, Baxter GD. Acupuncture for chronic low back pain: a randomized controlled feasibility trial comparing treatment session numbers. Clin Rehabil. 2017 Dec;31(12):1592-1603. doi: 10.1177/0269215517705690. Epub 2017 May 1.</citation>
    <PMID>28459161</PMID>
  </reference>
  <reference>
    <citation>Wang H, Yang G, Wang S, Zheng X, Zhang W, Li Y. The Most Commonly Treated Acupuncture Indications in the United States: A Cross-Sectional Study. Am J Chin Med. 2018 Oct 9:1-33. doi: 10.1142/S0192415X18500738. Online ahead of print.</citation>
    <PMID>30298749</PMID>
  </reference>
  <reference>
    <citation>Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.</citation>
    <PMID>29971708</PMID>
  </reference>
  <reference>
    <citation>Yin C, Buchheit TE, Park JJ. Acupuncture for chronic pain: an update and critical overview. Curr Opin Anaesthesiol. 2017 Oct;30(5):583-592. doi: 10.1097/ACO.0000000000000501.</citation>
    <PMID>28719458</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acupuncture</keyword>
  <keyword>Electroacupuncture</keyword>
  <keyword>Low back pain</keyword>
  <keyword>Aged</keyword>
  <keyword>Clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be made available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within one year of study completion.</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03802045
org study id: USaoPauloSA
nct id: NCT03802045
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Low back pain (LBP) is the most frequent complaint in the clinical practice.
      Electroacupuncture treatment may be effective, however, the evidence supporting this
      possibility is still limited, especially in older adults.

      Methods: A five-arm randomized controlled trial with patients and evaluators blinded to the
      group allocation. A total of 125 participants with non-specific low back pain will be
      randomly assigned into one of five groups: three electroacupuncture groups (low, high and
      alternating frequency), a control and a placebo group. The electroacupuncture will be applied
      twice a week (30 minutes per session) for 5 weeks. The primary clinical outcome will be pain
      intensity. The secondary outcomes include: quality of pain, physical functioning, perceived
      overall effect, emotional functionality, patient satisfaction and psychosocial factors.
      Patients will be evaluated before the first session, immediately after the last, and
      followed-up after 6 and 12 months to check the effects in the medium and long term.

      Discussion: Results of this trial will help clarify the therapeutic effect of different
      frequencies of electroacupuncture for chronic low back pain in older adults and to determine
      the most effective electroacupuncture frequency.
This study will be a randomized controlled clinical trial with blind evaluators and patients.
      The study will be conducted at the University of São Paulo (USP), approved by the Research
      Ethics Committee of the Medical School of USP (authorization No. 2.903.991) and financed with
      its own resources.

      Participants will be recruited through radio ads, social networks and local newspapers.
      Individuals will be informed about the research proposal and treatment protocol, and those
      that are interested in participating will be selected according to the inclusion and
      exclusion criteria.

      Patients will be eligible for inclusion if they are over 60 years of age, of either gender,
      with diagnosis of nonspecific LBP of more than 3 months duration, with or without radiating
      leg pain, with a minimum pain intensity score of 4 on the 11-point pain numerical rating
      scale (NRS - Brazilian Portuguese version), that can walk independently (with or without
      walking devices) and that agree to voluntarily participate in this study and sign the consent
      form.

      Patients will be excluded if they have had previous surgery on the spinal column, have a
      known or suspected serious spinal pathology (e.g., cancer, vertebral fracture, spinal
      infection or cauda equina syndrome), a fear of needles, have participated in acupuncture
      treatment in the previous 30 days, if they are wheelchair users, or if they are unable to
      sign the consent form.

      The protocol of this study is based on standards established under the Standards for
      Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) and the Initiative on
      Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).

      Prior to the first treatment session, the random allocation sequence will be implemented by a
      researcher not involved in the patient recruitment or evaluation, and will be generated
      through the randomization.com program, where each number will match one of five study groups.

      After the numbers are generated, they will be placed in sealed, brown envelopes and numbered
      in series, then given to the acupuncturist. This person will open them according to the
      numerical sequence, prior to the first session.

      Patients will remain blind regarding the category of their allocation throughout the data
      collection period of the study. Additionally, the evaluators responsible for the data
      collection will be blinded to the patient allocation. The acupuncturist, being responsible
      for the interventions, will be the only person not blind to the type of treatment to be
      performed.

      The interventions will be performed by acupuncture specialists with at least 3 years of
      clinical experience, who will receive prior training to ensure that they rigorously follow
      the study protocol and are familiar with the types of treatments, including details such as
      acupuncture points and manipulation of electroacupuncture parameters.

      Outcome measures Four stages of evaluations will be performed: prior to the start of
      treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the
      final treatment. The evaluators will be trained in advance.

      The primary clinical outcome will be pain intensity. The secondary outcomes will include
      quality of pain, physical functioning, perception of overall effect, emotional functionality,
      patient satisfaction and psychosocial factors. All the scales and questionnaires have been
      translated into Brazilian Portuguese, with the exception of the visual analog scale for the
      assessment of anxiety, and their properties clinimetrically tested.

      Primary outcomes Pain intensity Numerical Rating Scale (NRS) The NRS is an 11-point scale
      ranging from 0 (no pain) to 10 (worst possible pain). Participants will be asked to rate
      their average pain levels in the 24 hours prior to the assessment.

      Pressure pain threshold (PPT) The pressure pain threshold (PPT) will be measured using a
      pressure algometer (EMG system, Brazil). The assessed region will be marked with a tape
      measure and a dermatographic pencil. Two points will be marked bilaterally: 5 cm to the right
      and left of the spinous process of L3 and L5. A control point will be marked on the anterior
      tibial muscle of the right leg, 5 cm lateral to the tuberosity of the tibia. The circular tip
      of the algometer will be positioned perpendicular to the participant's skin and gradually
      pressed until the participant reports that the pressure has become painful and unbearable.
      Three measurements will be taken at each point with an interval of 1 minute. At the end, the
      arithmetic mean will be used to define the pressure pain threshold. To ensure data
      reliability, a preliminary intra-observer study will be conducted to measure the pressure
      pain threshold at the assessment points that will be used in the study. In this, 10
      participants will be evaluated and reassessed by the same examiner, with a 48-hour interval.
      The intraclass correlation coefficient (ICC) will be calculated by the measurements of the
      PPT of the anterior tibial and the lumbar points.

      Secondary outcomes Quality of pain This will be analyzed using the McGill Pain Questionnaire,
      a valid and reliable instrument containing 78 pain descriptors divided into 4 categories
      (sensory, affective, evaluative and miscellaneous) and 20 subcategories, to which scores of 1
      to 5 are attributed. The result is obtained by first scoring the words according to their
      position within the set of descriptors of each subcategory. The maximum score in the sensory
      category is 42, in the affective 14, in the evaluative 5 and in the miscellaneous 17. Then,
      the analysis is performed by adding these values associated with their categories. Higher
      scores equate to more intense pain. Physical functioning This measure will be assessed
      through the Roland Morris Disability Questionnaire and the Five Times Sit to Stand Test
      (FTSST).

      The first is a self-administered questionnaire, adapted to the Portuguese language, which
      aims to evaluate physical incapacity due to low back pain. This contains 24 items pertaining
      to activities that can be impaired due to LBP. Individuals need to select the items that
      apply to their pain on that day. The selected items are summed for a total score ranging from
      0 to 24, with higher scores indicating more severe functional incapacity. The activity of
      sitting and standing is a common and important movement in daily life, and in the clinical
      practice it helps to determine a person's functional level. The patient initiates the FTSST
      sitting in a chair without arm support, with the upper limbs crossed over the chest, feet
      positioned at hip width and knees in 90° flexion. They will be asked to stand and sit five
      times as fast as possible. A timer will be used to measure the task execution time. The test
      will be performed twice and the mean time will be calculated.

      Perceived overall effect The patient's self-perception regarding the treatment will be
      evaluated using the Global Effect Perception Scale, a 11-point numerical scale ranging from
      -5 (much worse) to +5 (much better), where higher scores represent better recovery.(18)
      Emotional functionality Depression and anxiety will be assessed using the Beck Depression
      Inventory (BDI) and the Global Anxiety - Visual Analog Scale (GA-VAS), respectively.

      The BDI is a self-administered questionnaire that contains 21 items, with a score ranging
      from 0 to 3, where a higher score indicates more depressive symptoms. The GA-VAS is composed
      of a 100mm line, where the left extremity is related to the absence of anxiety, and the right
      extremity is related to the worst possible anxiety. The individual is asked to assess the
      intensity of their anxiety in the previous 24 hours and to mark this on the line. The
      distance from the left edge of the line to the mark placed by the patient is measured in
      millimeters. Greater measurements indicate greater anxiety.

      Patient satisfaction The evaluation of the patient's satisfaction with the treatment will be
      carried out using the MedRisk questionnaire of patient satisfaction with physiotherapeutic
      care. This questionnaire contains 20 items, covering global aspects of the treatment (2
      items), aspects related to the service provided (8 items), and aspects about the
      therapist-patient relationship (10 items). Following a Likert-type scale, the patient's
      response will range from 1 (strongly disagree) to 5 (strongly agree), where higher scores
      represent greater satisfaction with the treatment.

      Psychosocial factors The risk of a poor prognosis due to psychosocial factors will be
      assessed using the STarT Back Screening Tool (SBST), a self-administered questionnaire with 9
      items (4 related to referred pain and 5 related to psychosocial factors) where the patient
      has the response options "I agree" (1 point) and "I Disagree" (zero points) in the first
      eight items, and "Nothing", "A little" or "Moderate" (zero points each), "A lot" or
      "Extremely" (one point each) in the ninth item. If the total score is between 0-3 points, the
      patient is classified as low risk for poor prognosis. When the total score is greater than 3
      points the score of the psychosocial subscale, questions 5 to 9, is then considered. If the
      score of this subscale is less than or equal to 3 points, the patient is classified as medium
      risk and scores greater than 3 points are considered to indicate a high risk for poor
      prognosis. Procedures After the randomization, the acupuncturist will sequentially open the
      envelopes, and the individuals will be randomly assigned to one of five treatment groups: Low
      frequency EA (LF), high frequency EA (HF), alternating frequency EA (AF), control group (C)
      and placebo group (P), each containing 25 participants. The acupuncture points will be
      located and described according to the WHO Standard Acupuncture Locations. Based on the
      beneficial effects of previous clinical trials, the acupoints selected for this study will
      be: BL23, BL25, BL40, SP6 and KI3.

      Interventions Participants of the LF, HF and AF groups will be submitted to the treatment
      protocol, which will consist of the bilateral application of electroacupuncture using a
      previously calibrated electrostimulator (Sikuro DS100C), consisted of alternating symmetrical
      biphasic waves with continuous pulse train for the low (2Hz) or high (100Hz) frequency
      groups, and a mixed pulse train for the alternating frequency group (100Hz and 2Hz for 3
      seconds each); 100ms pulse duration and 0.5ms pulse width; and the maximum current
      (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is
      avoided. Trichotomy will be carried out when necessary and the skin will be disinfected with
      70% alcohol. With the participant lying down in a ventral position, the needles will be
      inserted at a 90º inclination with the skin, to a depth at which that the patient reports the
      "deQi" sensation (≅ 1.5cm).

      The individuals that are randomly assigned to the C and P groups will follow exactly the same
      protocol as the electroacupuncture groups, however the C group will not undergo electrical
      stimulation, as the acupuncturist will activate channels that are not connected to the
      patient. In the P group an adhesive moxa (Dong Yang®) will be placed on each acupoint and the
      needle will be inserted over it, so that the participant only feels the needle prick, but
      without perforation of the skin and the "deQi" sensation. In addition, as in group C, the
      electrodes will be connected to the needles, however, no electrical current will be applied.
      Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc.,
      Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks,
      totaling 10 sessions.

      Sample size calculation The sample calculation was defined assuming a two-point difference in
      pain intensity through the Numerical Pain Scale, with an estimated standard deviation of 1.47
      points. Considering a test power of 80%, a significance level of 5% and a sample loss of 20%,
      25 participants will be recruited for each group (125 in total). (G * Power 3 3.1. 9.2).

      Statistical analysis The statistical analysis will be performed according to the
      intention-to-treat principle. An analysis of variance (ANOVA) will be used to examine the
      effect of the treatment, time (pre- and post-treatment, 6 and 12 months follow up), and the
      interaction between groups versus time. If differences between the groups are identified,
      Tukey's multiple comparison test will be conducted. Two-sided paired t-tests will use for
      within-group comparisons (comparing baseline to follow up). The non-parametric statistical
      test (Kruskal Wallis) will be used if the data is not normally distributed. All statistical
      analyses will be conducted using SPSS (IBM Co, Armonk, New York, USA) for Windows, V.19.0.
      The confidence interval will be established at 95%, and the significance level will be set at
      5%.

      Safety At each treatment session the participants will be asked about any unpleasant and
      unintended signs or symptoms associated with the use of electroacupuncture. A questionnaire
      will also be used with a record of the duration and intensity of the adverse symptom reported
      by the patient, which will be scored according to a Likert-type scale from 1 to 5, with 1
      representing the absence of adverse symptoms and 5 severe adverse symptoms.

      Ethics and data security All the patients will participate voluntarily and will sign a
      consent form prior to the randomization. The access and storage of the data will be in
      accordance with the guidelines of the National Research Ethics Commission (CONEP). This study
      has been approved by the Ethics Committee of the University of São Paulo Medical School
      (authorization No. 2.903.991) and is registered in Plataforma Brasil (CAAE:
      89846118.7.0000.0065).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The individuals will be randomly assigned to one of five treatment groups: Low frequency EA (LF) with 2Hz, high frequency EA (HF) with 100Hz, alternating frequency EA (AF) with 2 and 100Hz for 3 seconds each, control group (C) and placebo group (P), each containing 25 participants. The LF, HF and AF groups will be submitted to the treatment protocol, which will consist of the bilateral application of electroacupuncture using NKL® portable electrostimulator. The C and P groups will follow exactly the same protocol as the electroacupuncture groups, however the C group will not undergo electrical stimulation, as the acupuncturist will activate channels that are not connected to the patient. In the P group an adhesive moxa will be placed on each acupoint and the needle will be inserted over it. In addition, as in group C, the electrodes will be connected to the needles, however, no electrical current will be applied.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Prior to the first treatment session, the random allocation sequence will be implemented by a researcher not involved in the patient recruitment or evaluation, and will be generated through the randomization.com program, where each number will match one of five study groups.
After the numbers are generated, they will be placed in sealed, brown envelopes and numbered in series, then given to the acupuncturist. This person will open them according to the numerical sequence, prior to the first session.
Patients will remain blind regarding the category of their allocation throughout the data collection period of the study. Additionally, the evaluators responsible for the data collection and the outcomes assessor will be blinded to the patient allocation. The acupuncturist, being responsible for the interventions, will be the only person not blind to the type of treatment to be performed.
measure: Pain intensity - Numerical Rating Scale (NRS)
time frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
description: Will be measure using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Participants will be asked to rate their average pain levels in the 24 hours prior to the assessment.
measure: Pain intensity - Pressure pain threshold (PPT)
time frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
description: The PPT will be measured using a pressure algometer (EMG system, Brazil). The assessed region will be marked with a tape measure and a dermatographic pencil. Two points will be marked bilaterally: 5 cm to the right and left of the spinous process of L3 and L5. A control point will be marked on the anterior tibial muscle of the right leg, 5 cm lateral to the tuberosity of the tibia. The circular tip of the algometer will be positioned perpendicular to the participant's skin and gradually pressed until the participant reports that the pressure has become painful and unbearable. Three measurements will be taken at each point with an interval of 1 minute.
measure: Quality of pain
time frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
description: This will be analyzed using the McGill Pain Questionnaire, a valid and reliable instrument containing 78 pain descriptors divided into 4 categories (sensory, affective, evaluative and miscellaneous) and 20 subcategories, to which scores of 1 to 5 are attributed. The result is obtained by first scoring the words according to their position within the set of descriptors of each subcategory. The maximum score in the sensory category is 42, in the affective 14, in the evaluative 5 and in the miscellaneous 17. Then, the analysis is performed by adding these values associated with their categories. Higher scores equate to more intense pain.
measure: Perceived overall effect
time frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
description: The patient's self-perception regarding the treatment will be evaluated using the Global Effect Perception Scale, a 11-point numerical scale ranging from -5 (much worse) to +5 (much better), where higher scores represent better recovery.
measure: Emotional functionality - Depression
time frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
description: Depression will be assessed using the Beck Depression Inventory (BDI), a self-administered questionnaire that contains 21 items, with a score ranging from 0 to 3, where a higher score indicates more depressive symptoms.
measure: Patient satisfaction
time frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
description: The evaluation of the patient's satisfaction with the treatment will be carried out using the MedRisk questionnaire of patient satisfaction with physiotherapeutic care. This questionnaire contains 20 items, covering global aspects of the treatment (2 items), aspects related to the service provided (8 items), and aspects about the therapist-patient relationship (10 items). Following a Likert-type scale, the patient's response will range from 1 (strongly disagree) to 5 (strongly agree), where higher scores represent greater satisfaction with the treatment.
measure: Psychosocial factors
time frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
description: The risk of a poor prognosis due to psychosocial factors will be assessed using the STarT Back Screening Tool (SBST), a self-administered questionnaire with 9 items (4 related to referred pain and 5 related to psychosocial factors) where the patient has the response options "I agree" (1 point) and "I Disagree" (zero points) in the first eight items, and "Nothing", "A little" or "Moderate" (zero points each), "A lot" or "Extremely" (one point each) in the ninth item. If the total score is between 0-3 points, the patient is classified as low risk for poor prognosis. When the total score is greater than 3 points the score of the psychosocial subscale, questions 5 to 9, is then considered. If the score of this subscale is less than or equal to 3 points, the patient is classified as medium risk and scores greater than 3 points are considered to indicate a high risk for poor prognosis.
measure: Physical functioning - Roland Morris Disability Questionnaire
time frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
description: This measure will be assessed through the Roland Morris Disability Questionnaire. This is a self-administered questionnaire, adapted to the Portuguese language, which aims to evaluate physical incapacity due to low back pain. This contains 24 items pertaining to activities that can be impaired due to LBP. Individuals need to select the items that apply to their pain on that day. The selected items are summed for a total score ranging from 0 to 24, with higher scores indicating more severe functional incapacity.
measure: Emotional functionality - Anxiety
time frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
description: Anxiety will be assessed using the Global Anxiety - Visual Analog Scale (GA-VAS). This is composed of a 100mm line, where the left extremity is related to the absence of anxiety, and the right extremity is related to the worst possible anxiety. The individual is asked to assess the intensity of their anxiety in the previous 24 hours and to mark this on the line. The distance from the left edge of the line to the mark placed by the patient is measured in millimeters. Greater measurements indicate greater anxiety.
measure: Physical functioning - Five Times Sit to Stand Test
time frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment
description: This measure will be assessed through the Five Times Sit to Stand Test (FTSST). The patient initiates the FTSST sitting in a chair without arm support, with the upper limbs crossed over the chest, feet positioned at hip width and knees in 90° flexion. They will be asked to stand and sit five times as fast as possible. A timer will be used to measure the task execution time. The test will be performed twice and the mean time will be calculated.
arm group label: Low frequency EA
arm group type: Experimental
description: 25 participants will receive bilateral application of electroacupuncture using a previously calibrated EL 608 electrostimulator (NKL® portable), with the following parameters: balanced asymmetrical biphasic polarized pulse with continuous pulse train with 2Hz; 100ms pulse duration and 0.5ms pulse width; and the maximum current (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is avoided. Trichotomy will be carried out when necessary and the skin will be disinfected with 70% alcohol. With the participant lying down in a ventral position, the needles will be inserted at a 90º inclination with the skin, to a depth at which that the patient reports the "deQi" sensation (≅ 1.5cm).
arm group label: High frequency EA
arm group type: Experimental
description: 25 participants will receive 25 participants will receive bilateral application of electroacupuncture using a previously calibrated EL 608 electrostimulator (NKL® portable), with the following parameters: balanced asymmetrical biphasic polarized pulse with continuous pulse train with 100Hz; 100ms pulse duration and 0.5ms pulse width; and the maximum current (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is avoided. Trichotomy will be carried out when necessary and the skin will be disinfected with 70% alcohol. With the participant lying down in a ventral position, the needles will be inserted at a 90º inclination with the skin, to a depth at which that the patient reports the "deQi" sensation (≅ 1.5cm).
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.
arm group label: Alternating frequency EA
arm group type: Experimental
description: 25 participants will receive 25 participants will receive bilateral application of electroacupuncture using a previously calibrated EL 608 electrostimulator (NKL® portable), with the following parameters: balanced asymmetrical biphasic polarized pulse with continuous pulse train with 100Hz and 2Hz for 3 seconds each; 100ms pulse duration and 0.5ms pulse width; and the maximum current (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is avoided. Trichotomy will be carried out when necessary and the skin will be disinfected with 70% alcohol. With the participant lying down in a ventral position, the needles will be inserted at a 90º inclination with the skin, to a depth at which that the patient reports the "deQi" sensation (≅ 1.5cm).
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.
arm group label: Control Group
arm group type: Active Comparator
description: 25 participants will follow exactly the same protocol as the experimental groups, however they will not undergo electrical stimulation, as the acupuncturist will activate channels that are not connected to the patient.
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.
arm group label: Placebo Group
arm group type: Placebo Comparator
description: 25 participants will will follow exactly the same protocol as the experimental groups, however an adhesive moxa (Dong Yang®) will be placed on each acupoint and the needle will be inserted over it, so that the participant only feels the needle prick, but without perforation of the skin and the "deQi" sensation. In addition, as in the control group, the electrodes will be connected to the needles, however, no electrical current will be applied.
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.
intervention type: Procedure
intervention name: Electroacupuncture
description: The interventions will be performed by acupuncture specialists with at least 3 years of clinical experience, who will receive prior training to ensure that they rigorously follow the study protocol and are familiar with the types of treatments, including details such as acupuncture points and manipulation of electroacupuncture parameters.
After the randomization, the acupuncturist will sequentially open the envelopes, and the individuals will be randomly assigned to one of five treatment groups: Low frequency EA (LF), high frequency EA (HF), alternating frequency EA (AF), control group (C) and placebo group (P), each containing 25 participants. The acupuncture points will be located and described according to the WHO Standard Acupuncture Locations. Based on the beneficial effects of previous clinical trials, the acupoints selected for this study will be: BL23, BL25, BL40, SP6 and KI3.
arm group label: Alternating frequency EA
arm group label: High frequency EA
arm group label: Low frequency EA
other name: Acupuncture
intervention type: Device
intervention name: Needle
description: Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used.
arm group label: Alternating frequency EA
arm group label: Control Group
arm group label: High frequency EA
arm group label: Low frequency EA
arm group label: Placebo Group
intervention type: Device
intervention name: Adhesive Moxa
description: In the placebo group an adhesive moxa will be placed on each acupoint and the needle will be inserted over it.
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sarina F Torres, Master´s
phone: 41985120128
phone ext: 55
email: sarinaftorres@gmail.com
last name: Amélia P Marques, PhD
phone: 113893-4401
phone ext: 55
email: pasqual@usp.br
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
citation: Malta DC, Oliveira MM, Andrade SSCA, Caiaffa WT, Souza MFM, Bernal RTI. Factors associated with chronic back pain in adults in Brazil. Rev Saude Publica. 2017 Jun 1;51(suppl 1):9s. doi: 10.1590/S1518-8787.2017051000052.
PMID: 28591350
citation: Wong AYL, Karppinen J, Samartzis D. Low back pain in older adults: risk factors, management options and future directions. Scoliosis Spinal Disord. 2017 Apr 18;12:14. doi: 10.1186/s13013-017-0121-3. eCollection 2017.
PMID: 28435906
citation: Robinson HS, Dagfinrud H. Reliability and screening ability of the StarT Back screening tool in patients with low back pain in physiotherapy practice, a cohort study. BMC Musculoskelet Disord. 2017 May 31;18(1):232. doi: 10.1186/s12891-017-1553-x.
PMID: 28569152
citation: Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
PMID: 28192789
citation: Chou R, Deyo R, Friedly J, Skelly A, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S. Systemic Pharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):480-492. doi: 10.7326/M16-2458. Epub 2017 Feb 14.
PMID: 28192790
citation: Langevin HM, Schnyer R, MacPherson H, Davis R, Harris RE, Napadow V, Wayne PM, Milley RJ, Lao L, Stener-Victorin E, Kong JT, Hammerschlag R; Executive Board of the Society for Acupuncture Research. Manual and electrical needle stimulation in acupuncture research: pitfalls and challenges of heterogeneity. J Altern Complement Med. 2015 Mar;21(3):113-28. doi: 10.1089/acm.2014.0186. Epub 2015 Feb 24.
PMID: 25710206
citation: Comachio J, Oliveira Magalhaes M, Nogueira Burke T, Vidal Ramos LA, Peixoto Leao Almeida G, Silva AP, Ferreira de Meneses SR, Costa-Frutuoso JR, Santos Miotto Amorim C, Pasqual Marques A. Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial. Trials. 2015 Oct 15;16:469. doi: 10.1186/s13063-015-0850-7.
PMID: 26472590
citation: Liu L, Skinner M, McDonough S, Mabire L, Baxter GD. Acupuncture for low back pain: an overview of systematic reviews. Evid Based Complement Alternat Med. 2015;2015:328196. doi: 10.1155/2015/328196. Epub 2015 Mar 4.
PMID: 25821485
citation: MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010 Jun 8;7(6):e1000261. doi: 10.1371/journal.pmed.1000261.
PMID: 20543992
citation: Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
PMID: 15621359
citation: Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe.
PMID: 18923324
citation: Nusbaum L, Natour J, Ferraz MB, Goldenberg J. Translation, adaptation and validation of the Roland-Morris questionnaire--Brazil Roland-Morris. Braz J Med Biol Res. 2001 Feb;34(2):203-10. doi: 10.1590/s0100-879x2001000200007.
PMID: 11175495
citation: Menezes Costa Lda C, Maher CG, McAuley JH, Hancock MJ, de Melo Oliveira W, Azevedo DC, Freitas Pozzi LM, Pereira AR, Costa LO. The Brazilian-Portuguese versions of the McGill Pain Questionnaire were reproducible, valid, and responsive in patients with musculoskeletal pain. J Clin Epidemiol. 2011 Aug;64(8):903-12. doi: 10.1016/j.jclinepi.2010.12.009. Epub 2011 Mar 27.
PMID: 21444194
citation: Gomes-Oliveira MH, Gorenstein C, Lotufo Neto F, Andrade LH, Wang YP. Validation of the Brazilian Portuguese version of the Beck Depression Inventory-II in a community sample. Braz J Psychiatry. 2012 Dec;34(4):389-94. doi: 10.1016/j.rbp.2012.03.005.
PMID: 23429809
citation: de Fatima Costa Oliveira N, Oliveira Pena Costa L, Nelson R, Maher CG, Beattie PF, de Bie R, Oliveira W, Camara Azevedo D, da Cunha Menezes Costa L. Measurement properties of the Brazilian Portuguese version of the MedRisk instrument for measuring patient satisfaction with physical therapy care. J Orthop Sports Phys Ther. 2014 Nov;44(11):879-89. doi: 10.2519/jospt.2014.5150.
PMID: 25361861
citation: Pilz B, Vasconcelos RA, Marcondes FB, Lodovichi SS, Mello W, Grossi DB. The Brazilian version of STarT Back Screening Tool - translation, cross-cultural adaptation and reliability. Braz J Phys Ther. 2014 Sep-Oct;18(5):453-61. doi: 10.1590/bjpt-rbf.2014.0028. Epub 2014 Aug 29.
PMID: 25372008
citation: Varoli FK, Pedrazzi V. Adapted version of the McGill Pain Questionnaire to Brazilian Portuguese. Braz Dent J. 2006;17(4):328-35. doi: 10.1590/s0103-64402006000400012.
PMID: 17262148
citation: Kahraman T, Ozcan Kahraman B, Salik Sengul Y, Kalemci O. Assessment of sit-to-stand movement in nonspecific low back pain: a comparison study for psychometric properties of field-based and laboratory-based methods. Int J Rehabil Res. 2016 Jun;39(2):165-70. doi: 10.1097/MRR.0000000000000164.
PMID: 27031182
citation: Gorenstein C, Andrade L, Vieira Filho AH, Tung TC, Artes R. Psychometric properties of the Portuguese version of the Beck Depression Inventory on Brazilian college students. J Clin Psychol. 1999 May;55(5):553-62. doi: 10.1002/(sici)1097-4679(199905)55:53.0.co;2-d.
PMID: 10392786
citation: Williams VS, Morlock RJ, Feltner D. Psychometric evaluation of a visual analog scale for the assessment of anxiety. Health Qual Life Outcomes. 2010 Jun 8;8:57. doi: 10.1186/1477-7525-8-57.
PMID: 20529361
citation: WHO standard acupuncture point locations in the Western Pacific Region. Manila, Philippines. 2009:1-242.
citation: Liu L, Skinner MA, McDonough SM, Baxter GD. Acupuncture for chronic low back pain: a randomized controlled feasibility trial comparing treatment session numbers. Clin Rehabil. 2017 Dec;31(12):1592-1603. doi: 10.1177/0269215517705690. Epub 2017 May 1.
PMID: 28459161
citation: Wang H, Yang G, Wang S, Zheng X, Zhang W, Li Y. The Most Commonly Treated Acupuncture Indications in the United States: A Cross-Sectional Study. Am J Chin Med. 2018 Oct 9:1-33. doi: 10.1142/S0192415X18500738. Online ahead of print.
PMID: 30298749
citation: Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.
PMID: 29971708
citation: Yin C, Buchheit TE, Park JJ. Acupuncture for chronic pain: an update and critical overview. Curr Opin Anaesthesiol. 2017 Oct;30(5):583-592. doi: 10.1097/ACO.0000000000000501.
PMID: 28719458
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be available within one year of study completion.
ipd access criteria: Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.