<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/NCT04490798</url>
  </required_header>
  <id_info>
    <org_study_id>ACUPATHWAY.R.1</org_study_id>
    <nct_id>NCT04490798</nct_id>
  </id_info>
  <brief_title>Effectiveness of Acupuncture Clinical Pathway</brief_title>
  <acronym>ACUPATHWAY</acronym>
  <official_title>A Retrospective Longitudinal Cohort Study to Determine the Effectiveness of Integrated a Clinical Pathway Approach for Chronic Pain Treatment With Acupuncture in a Pain Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Son Llatzer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Son Llatzer</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The study will be described the development and implementation of the Clinical pathway (CPW)&#xD;
      for acupuncture treatment in the management of patients with some chronic pain conditions.&#xD;
      The effectiveness of this CPW will be explored in this study through retrospective analysis&#xD;
      of clinical outcomes after administration of acupuncture treatment summarised in the&#xD;
      guidelines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This longitudinal, observational, retrospective study included adults (&gt;18 years) with common&#xD;
      chronic pain condition treated at the Son Llàtzer University Hospital Pain Clinic, in Palma&#xD;
      de Mallorca, Spain, from January 2015 to December 2018. All patients received treatment&#xD;
      according to the Acupuncture Clinical Pathway developed. The primary outcome measures will be&#xD;
      a change in pain intensity measured by VAS for pain at the completion of treatment. Number of&#xD;
      responder patients, reduction of pain medication intake, improve of quality of live scale,&#xD;
      sleep quality index and scale of anxiety and depression after treatment are also to be&#xD;
      included in the study.&#xD;
&#xD;
      The purpose of this study is to assess the effectiveness of integrated a clinical pathway&#xD;
      approach for chronic pain treatment with acupuncture in a Pain Clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain intensity measured by VAS for pain at the completion of treatment</measure>
    <time_frame>Baseline and after the completion of treatment at 4 months</time_frame>
    <description>Overall average pain intensity over the last month will be assessed by a continuous scale comprised of a horizontal line, anchored by 'no pain' (score of 0) and 'worst imaginable pain' (score of 100 (100 mm scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of responder patients to the acupuncture treatment.</measure>
    <time_frame>Baseline, 1 month and after the completion of treatment at 4 months</time_frame>
    <description>Responders will be defined as patients with a reduction of pain scores of more than 30%, decreasing medication intake or improving quality of live scale (≥ 20%), sleep quality index (≥ 30%) following our Clinical Pathway.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of pain medication intake after treatment</measure>
    <time_frame>Baseline, 1 month and after the completion of treatment at 4 months</time_frame>
    <description>Analgesic medicine use will be obtained with a questionnaire elaborated according to the European Health Interview Survey (EUROHIS) recommendations. Subjects will be asked (1) about the prescription medicine their general practitioner may have prescribed for them ('Have you taken any pain medicine prescribed by your general practitioner?') as well as any medication not prescribed by their general practitioner ('Have you taken any pain medicine not prescribed by your general practitioner') and (2) whether their prescribed and non-prescribed pain medication use has increased or decreased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improve of quality of live scale after treatment</measure>
    <time_frame>Baseline, 1 month and after the completion of treatment at 4 months</time_frame>
    <description>Patient-related quality of live by SF-12 measured. The Spanish version validated by Schmidt S et al is used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improve sleep quality index after treatment</measure>
    <time_frame>Baseline, 1 month and after the completion of treatment at 4 months</time_frame>
    <description>Measured with the Pittsburgh Sleep Quality Index (PSQ). The Spanish version validated by Hita-Contreras F et al is used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improve of scale of anxiety and depression after treatment</measure>
    <time_frame>Baseline, 1 month and after the completion of treatment at 4 months</time_frame>
    <description>Levels of depression and anxiety will be measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al is used.</description>
  </secondary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Actual">3245</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Lumbar Back Pain</condition>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Headache</condition>
  <condition>Shoulder Pain</condition>
  <condition>Cervicalgia</condition>
  <condition>Musculoskeletal Pain</condition>
  <arm_group>
    <arm_group_label>Lumbar back pain</arm_group_label>
    <description>Patients with lumbar back pain treated following the Acupuncture Treatment Clinic Pathway.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Musculoskeletal pain</arm_group_label>
    <description>Patients with musculoskeletal pain treated following the Acupuncture Treatment Clinic Pathway.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervicalgia</arm_group_label>
    <description>Patients with cervicalgia treated following the Acupuncture Treatment Clinic Pathway.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Knee osteoarthritis</arm_group_label>
    <description>Patients with knee osteoarthritis treated following the Acupuncture Treatment Clinic Pathway.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Headache</arm_group_label>
    <description>Patients with headache treated following the Acupuncture Treatment Clinic Pathway.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Shoulder pain</arm_group_label>
    <description>Patients with shoulder pain treated following the Acupuncture Treatment Clinic Pathway.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <description>The electro-acupuncture device was a biphasic pulse generator. It was used with maximum tolerable intensity of current and a frequency of 3 Hz. The points were selected according to the Traditional Chinese Medicine meridian theory to treat the different painful syndromes. Just as in a regular acupuncture treatment, needles are inserted into acupuncture points but small crocodile clips are then attached to the ends of needles to connect them to an electro-acupuncture device. In traditional acupuncture the inserted needles are manually vibrated to induce a response whilst in electro-acupuncture the bi-phasic current results in a constant (controlled) vibration of the needles and a direct electrical stimulation.</description>
    <arm_group_label>Cervicalgia</arm_group_label>
    <arm_group_label>Headache</arm_group_label>
    <arm_group_label>Knee osteoarthritis</arm_group_label>
    <arm_group_label>Lumbar back pain</arm_group_label>
    <arm_group_label>Musculoskeletal pain</arm_group_label>
    <arm_group_label>Shoulder pain</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients (&gt;18 years), who received acupuncture treatment for chronic pain&#xD;
        (cervicalgia, low back pain, knee osteoarthritis, shoulder pain, headache or&#xD;
        musculoskeletal pain), applying Acupuncture Treatment Clinical Pathway.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult patients (&gt;18 years) Acupuncture treatment for chronic pain (cervicalgia, low back&#xD;
        pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), Applying&#xD;
        Acupuncture treatment Clinical Pathway and completed at least 50% of the medical&#xD;
        appointments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Adult patients (&gt;18 years) Acupuncture treatment for chronic pain (cervicalgia, low back&#xD;
        pain, knee osteoarthritis, shoulder pain, headache or musculoskeletal pain), Without&#xD;
        applying Acupuncture treatment Clinical Pathway or not completed at least 50% of the&#xD;
        medical appointments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier Mata, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anaesthesia Department, Son Llàtzer University Hospital. Palma, Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Son Llatzer University Hospital</name>
      <address>
        <city>Palma</city>
        <state>Balear Islands</state>
        <zip>07198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://wonder.cdc.gov</url>
    <description>Wide-ranging online data for epidemiologic research (WONDER). , &quot;Atlanta, GA: CDC, National Center for Health Statistics,&quot; 2016. [Online]. Available: http://wonder.cdc.gov.. [Accessed 7 july 2020].</description>
  </link>
  <reference>
    <citation>Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.</citation>
    <PMID>9820257</PMID>
  </reference>
  <reference>
    <citation>Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.</citation>
    <PMID>22965186</PMID>
  </reference>
  <reference>
    <citation>Lee MS, Ernst E. Acupuncture for pain: an overview of Cochrane reviews. Chin J Integr Med. 2011 Mar;17(3):187-9. doi: 10.1007/s11655-011-0665-7. Epub 2011 Feb 27.</citation>
    <PMID>21359919</PMID>
  </reference>
  <reference>
    <citation>Vickers AJ, Linde K. Acupuncture for chronic pain. JAMA. 2014 Mar 5;311(9):955-6. doi: 10.1001/jama.2013.285478.</citation>
    <PMID>24595780</PMID>
  </reference>
  <reference>
    <citation>Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.</citation>
    <PMID>26977696</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>
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    <citation>Camm AJ, Fox KAA. Strengths and weaknesses of 'real-world' studies involving non-vitamin K antagonist oral anticoagulants. Open Heart. 2018 Apr 21;5(1):e000788. doi: 10.1136/openhrt-2018-000788. eCollection 2018.</citation>
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    <citation>Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.</citation>
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    <citation>von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.</citation>
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    <citation>Nosikov A , Gudex C . eds. EUROHIS:, &quot;Developing common instruments for health surveys. Amsterdam: IOS Press, 2003.&quot;.</citation>
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    <citation>Monton C, Perez Echeverria MJ, Campos R, Garcia Campayo J, Lobo A. [Anxiety scales and Goldberg's depression: an efficient interview guide for the detection of psychologic distress]. Aten Primaria. 1993 Oct 15;12(6):345-9. Spanish.</citation>
    <PMID>8218816</PMID>
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    <citation>Schmidt S, Vilagut G, Garin O, Cunillera O, Tresserras R, Brugulat P, Mompart A, Medina A, Ferrer M, Alonso J. [Reference guidelines for the 12-Item Short-Form Health Survey version 2 based on the Catalan general population]. Med Clin (Barc). 2012 Dec 8;139(14):613-25. doi: 10.1016/j.medcli.2011.10.024. Epub 2012 Jan 11. Spanish.</citation>
    <PMID>22244683</PMID>
  </reference>
  <reference>
    <citation>Hita-Contreras F, Martinez-Lopez E, Latorre-Roman PA, Garrido F, Santos MA, Martinez-Amat A. Reliability and validity of the Spanish version of the Pittsburgh Sleep Quality Index (PSQI) in patients with fibromyalgia. Rheumatol Int. 2014 Jul;34(7):929-36. doi: 10.1007/s00296-014-2960-z. Epub 2014 Feb 8.</citation>
    <PMID>24509897</PMID>
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    <citation>Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009 Dec;146(3):238-244. doi: 10.1016/j.pain.2009.08.019.</citation>
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  </reference>
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    <citation>Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.</citation>
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    <citation>Herman JP, Figueiredo H, Mueller NK, Ulrich-Lai Y, Ostrander MM, Choi DC, Cullinan WE. Central mechanisms of stress integration: hierarchical circuitry controlling hypothalamo-pituitary-adrenocortical responsiveness. Front Neuroendocrinol. 2003 Jul;24(3):151-80. doi: 10.1016/j.yfrne.2003.07.001.</citation>
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    <citation>Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 2009 Sep;47(3):1077-85. doi: 10.1016/j.neuroimage.2009.05.083. Epub 2009 Jun 6.</citation>
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    <citation>Zubieta JK, Stohler CS. Neurobiological mechanisms of placebo responses. Ann N Y Acad Sci. 2009 Mar;1156:198-210. doi: 10.1111/j.1749-6632.2009.04424.x.</citation>
    <PMID>19338509</PMID>
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    <citation>Lee SC, Yin SJ, Lee ML, Tsai WJ, Sim CB. Effects of acupuncture on serum cortisol level and dopamine beta-hydroxylase activity in normal Chinese. Am J Chin Med. 1982;10(1-4):62-9. doi: 10.1142/S0192415X82000117.</citation>
    <PMID>7183209</PMID>
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    <citation>Schneider A, Weiland C, Enck P, Joos S, Streitberger K, Maser-Gluth C, Zipfel S, Bagheri S, Herzog W, Friederich HC. Neuroendocrinological effects of acupuncture treatment in patients with irritable bowel syndrome. Complement Ther Med. 2007 Dec;15(4):255-63. doi: 10.1016/j.ctim.2006.12.002. Epub 2007 Feb 20.</citation>
    <PMID>18054727</PMID>
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    <citation>Tsigos C, Chrousos GP. Hypothalamic-pituitary-adrenal axis, neuroendocrine factors and stress. J Psychosom Res. 2002 Oct;53(4):865-71. doi: 10.1016/s0022-3999(02)00429-4.</citation>
    <PMID>12377295</PMID>
  </reference>
  <reference>
    <citation>Lawal AK, Rotter T, Kinsman L, Machotta A, Ronellenfitsch U, Scott SD, Goodridge D, Plishka C, Groot G. What is a clinical pathway? Refinement of an operational definition to identify clinical pathway studies for a Cochrane systematic review. BMC Med. 2016 Feb 23;14:35. doi: 10.1186/s12916-016-0580-z.</citation>
    <PMID>26904977</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Son Llatzer</investigator_affiliation>
    <investigator_full_name>Javier Mata</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>acupuncture treatment</keyword>
  <keyword>clinical pathway</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Headache</mesh_term>
    <mesh_term>Neck Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04490798
org study id: ACUPATHWAY.R.1
nct id: NCT04490798
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study will be described the development and implementation of the Clinical pathway (CPW)
      for acupuncture treatment in the management of patients with some chronic pain conditions.
      The effectiveness of this CPW will be explored in this study through retrospective analysis
      of clinical outcomes after administration of acupuncture treatment summarised in the
      guidelines.
This longitudinal, observational, retrospective study included adults (>18 years) with common
      chronic pain condition treated at the Son Llàtzer University Hospital Pain Clinic, in Palma
      de Mallorca, Spain, from January 2015 to December 2018. All patients received treatment
      according to the Acupuncture Clinical Pathway developed. The primary outcome measures will be
      a change in pain intensity measured by VAS for pain at the completion of treatment. Number of
      responder patients, reduction of pain medication intake, improve of quality of live scale,
      sleep quality index and scale of anxiety and depression after treatment are also to be
      included in the study.

      The purpose of this study is to assess the effectiveness of integrated a clinical pathway
      approach for chronic pain treatment with acupuncture in a Pain Clinic.
observational model: Cohort
time perspective: Retrospective
measure: Change in pain intensity measured by VAS for pain at the completion of treatment
time frame: Baseline and after the completion of treatment at 4 months
description: Overall average pain intensity over the last month will be assessed by a continuous scale comprised of a horizontal line, anchored by 'no pain' (score of 0) and 'worst imaginable pain' (score of 100 (100 mm scale)
measure: Number of responder patients to the acupuncture treatment.
time frame: Baseline, 1 month and after the completion of treatment at 4 months
description: Responders will be defined as patients with a reduction of pain scores of more than 30%, decreasing medication intake or improving quality of live scale (≥ 20%), sleep quality index (≥ 30%) following our Clinical Pathway.
measure: Reduction of pain medication intake after treatment
time frame: Baseline, 1 month and after the completion of treatment at 4 months
description: Analgesic medicine use will be obtained with a questionnaire elaborated according to the European Health Interview Survey (EUROHIS) recommendations. Subjects will be asked (1) about the prescription medicine their general practitioner may have prescribed for them ('Have you taken any pain medicine prescribed by your general practitioner?') as well as any medication not prescribed by their general practitioner ('Have you taken any pain medicine not prescribed by your general practitioner') and (2) whether their prescribed and non-prescribed pain medication use has increased or decreased.
measure: Improve of quality of live scale after treatment
time frame: Baseline, 1 month and after the completion of treatment at 4 months
description: Patient-related quality of live by SF-12 measured. The Spanish version validated by Schmidt S et al is used
measure: Improve sleep quality index after treatment
time frame: Baseline, 1 month and after the completion of treatment at 4 months
description: Measured with the Pittsburgh Sleep Quality Index (PSQ). The Spanish version validated by Hita-Contreras F et al is used
measure: Improve of scale of anxiety and depression after treatment
time frame: Baseline, 1 month and after the completion of treatment at 4 months
description: Levels of depression and anxiety will be measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al is used.
arm group label: Lumbar back pain
description: Patients with lumbar back pain treated following the Acupuncture Treatment Clinic Pathway.
arm group label: Musculoskeletal pain
description: Patients with musculoskeletal pain treated following the Acupuncture Treatment Clinic Pathway.
arm group label: Cervicalgia
description: Patients with cervicalgia treated following the Acupuncture Treatment Clinic Pathway.
arm group label: Knee osteoarthritis
description: Patients with knee osteoarthritis treated following the Acupuncture Treatment Clinic Pathway.
arm group label: Headache
description: Patients with headache treated following the Acupuncture Treatment Clinic Pathway.
arm group label: Shoulder pain
description: Patients with shoulder pain treated following the Acupuncture Treatment Clinic Pathway.
intervention type: Procedure
intervention name: Electroacupuncture
description: The electro-acupuncture device was a biphasic pulse generator. It was used with maximum tolerable intensity of current and a frequency of 3 Hz. The points were selected according to the Traditional Chinese Medicine meridian theory to treat the different painful syndromes. Just as in a regular acupuncture treatment, needles are inserted into acupuncture points but small crocodile clips are then attached to the ends of needles to connect them to an electro-acupuncture device. In traditional acupuncture the inserted needles are manually vibrated to induce a response whilst in electro-acupuncture the bi-phasic current results in a constant (controlled) vibration of the needles and a direct electrical stimulation.
arm group label: Cervicalgia
arm group label: Headache
arm group label: Knee osteoarthritis
arm group label: Lumbar back pain
arm group label: Musculoskeletal pain
arm group label: Shoulder pain
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javier Mata, MD
role: Principal Investigator
affiliation: Anaesthesia Department, Son Llàtzer University Hospital. Palma, Spain
facility: 
country: Spain
url: https://wonder.cdc.gov
description: Wide-ranging online data for epidemiologic research (WONDER). , "Atlanta, GA: CDC, National Center for Health Statistics," 2016. [Online]. Available: http://wonder.cdc.gov.. [Accessed 7 july 2020].
citation: Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.
PMID: 9820257
citation: Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
PMID: 22965186
citation: Lee MS, Ernst E. Acupuncture for pain: an overview of Cochrane reviews. Chin J Integr Med. 2011 Mar;17(3):187-9. doi: 10.1007/s11655-011-0665-7. Epub 2011 Feb 27.
PMID: 21359919
citation: Vickers AJ, Linde K. Acupuncture for chronic pain. JAMA. 2014 Mar 5;311(9):955-6. doi: 10.1001/jama.2013.285478.
PMID: 24595780
citation: Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.
PMID: 26977696
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responsible party type: Principal Investigator
investigator affiliation: Hospital Son Llatzer
investigator full name: Javier Mata
investigator title: Principal Investigator
mesh term: Shoulder Pain
mesh term: Osteoarthritis, Knee
mesh term: Musculoskeletal Pain
mesh term: Chronic Pain
mesh term: Headache
mesh term: Neck Pain
mesh term: Low Back Pain
sharing ipd: No