<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/NCT02969785</url>
  </required_header>
  <id_info>
    <org_study_id>Rubens A. da Silva</org_study_id>
    <nct_id>NCT02969785</nct_id>
  </id_info>
  <brief_title>Postural Control and Trunk Neuromuscular Activation in Athletes With Chronic Low Back Pain</brief_title>
  <acronym>PCMALBP</acronym>
  <official_title>An Intervention Program for the Trunk Neuromuscular Pattern and Postural Control in Athletes Chronic With Low Back Pain: A Feasibility and Clinical Trial Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Norte do Paraná</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Norte do Paraná</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 relevance of this study is given by the feasibility to assess the effect of an&#xD;
      intervention program based on the postural control and trunk neuromuscular activity,&#xD;
      comparing two methods: stabilization exercises vs. back strengthening exercises, in athletes&#xD;
      with low back pain. The main outcomes will be computed by electromyography measurement so&#xD;
      that to assess the trunk neuromuscular activation pattern as well as by force platform&#xD;
      parameters for determining of postural control. Clinical symptoms such as pain intensity,&#xD;
      perception of disability and fear and avoidance will also be computed. This is the first&#xD;
      study to compare two intervention methods using the main biological outcomes related to trunk&#xD;
      neuromuscular function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this study, a proposal of a 8-week intervention program will be carried out with lumbar&#xD;
      stabilization exercises and back strengthening exercises, in 32 athletes with chronic low&#xD;
      back, recruited by convenience and voluntaries from the community local and sports centers.&#xD;
      Before intervention, all participantes will be evaluated by: electromoyography during back&#xD;
      endurance and strength tests, balance performance, physical capacity, and by clinical&#xD;
      outcomes such as pain, disability and psychological factors. All baseline testing and&#xD;
      evaluation will be performed by a blinded evaluator to the study intervention. Afterwards,&#xD;
      the participants will be randomized in two groups by a blinded evaluator (people not enroled&#xD;
      to study): G1: exercises for lumbar stabilization; and G2: strengthening exercises. The&#xD;
      intervention will follow 8 weeks, with 50 minutes of duration each session of therapy&#xD;
      including measurement of blood pressure, heart rate and the Visual Analogue Scale (VAS)&#xD;
      before and after each session, and the perception of exercise intensity monitored by Borg&#xD;
      Scale. Within this proposal, the exercise sessions will performed twice a week. The&#xD;
      intervention will follow the CONSORT recommendations for randomized controlled trials. The&#xD;
      intervention will start in: G1 (n=16, motor control group), which will perform therapy with&#xD;
      specific exercises for lumbar stabilization including the Swiss ball as therapeutic resource;&#xD;
      while G2 (n=16, strength group) will perform back endurance progressive and resisted&#xD;
      exercises on a Roman chair. The participants will not be blind to the study due to the&#xD;
      characteristic of the exercises that often reflect to the improvement of the symptoms. In&#xD;
      case of eventual losses, the intention-to-treat method will be used for the analyses. After&#xD;
      the intervention, all groups will be invited to come back to the laboratory to proceed the&#xD;
      same evaluation from baseline (trunk activation during exercises, balance, and clinical&#xD;
      outcomes). For the analysis two-way ANOVA with repeated measures will be performed to compare&#xD;
      the effects of the intervention (two groups) and times (baseline vs. end 8-weeks measurement)&#xD;
      and the effects of interaction (Groups x Times). The size effect also will be computed to&#xD;
      determine the rate of the changes observed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">April 28, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eletromyography measurement</measure>
    <time_frame>Change from baseline muscular activation at 8 weeks</time_frame>
    <description>EMG estimates, Root Mean Square: RMS (in microvolts unit: uV) and Median Frequency: MF (in Hertz: Hz) will be computed to evaluate the back activation during strength maximal protocol and endurance dynamic test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Force platform measurement</measure>
    <time_frame>Change from baseline muscular activation at 8 weeks</time_frame>
    <description>Force platform measurement during balance performance using centre of pressure measures to assess balance performance.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Visual Analogic Scale</measure>
    <time_frame>Change from baseline muscular activation at 8 weeks</time_frame>
    <description>Pain measurement using Short Version of Pain Questionnaire McGill (score 0 to 78; while higher score is determined by poor condition related to pain) and Visual Analogue Scale for pain intensity (score of 0 to 10 intensity; being 10 of poor score for VAS).</description>
  </other_outcome>
  <other_outcome>
    <measure>Disability questionnaire</measure>
    <time_frame>Change from baseline muscular activation at 8 weeks</time_frame>
    <description>Disability measurement using Oswestry questionnaire.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fear-avoidance questionnaire</measure>
    <time_frame>Change from baseline muscular activation at 8 weeks</time_frame>
    <description>Fear-avoidance model measurement using Waddel questionnaire related to work and physical activity.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Athletic Injury</condition>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>G1: exercises for lumbar stabilization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Specific exercises for lumbar stabilization. The Group 1 (G1) will perform therapy with specific exercises for lumbar stabilization whith the Swiss ball as a therapeutic resource, including warming; stretching of hamstrings, paraspinals, trapezes; phasic perineal exercise; tonic perineal exercise; pelvic lumbar synergism; trunk mobility; mobility of the shoulder girdle; balance; and slow pelvic balance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G2: back strengthening exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Back strengthening exercises. The Group 2 (G2) will perform therapy including strengthning of back muscles on a Roman chair machine for flexion and extension of trunk with load progression from training volume for endurance and strength gains.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>G1: exercises for lumbar stabilization</intervention_name>
    <description>Specific exercises for lumbar stabilization. The Group 1 (G1) will perform therapy with specific exercises for lumbar stabilization whith the Swiss ball as a therapeutic resource, including warming; stretching of hamstrings, paraspinals, trapezes; phasic perineal exercise; tonic perineal exercise; pelvic lumbar synergism; trunk mobility; mobility of the shoulder girdle; balance; and slow pelvic balance.</description>
    <arm_group_label>G1: exercises for lumbar stabilization</arm_group_label>
    <other_name>therapeutic exercises</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>G2: back strengthening exercises</intervention_name>
    <description>Specific back exercises. The Group 2 (G2) will perform therapy including back strengthing exercise on a Roman chair machine to perform flexion and extension of trunk with load progressive training.</description>
    <arm_group_label>G2: back strengthening exercises</arm_group_label>
    <other_name>Back resistive training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic low back pain at least for three months, in a unique or multiple episodes.&#xD;
&#xD;
          -  low back pain of unknown origin and mechanical nature.&#xD;
&#xD;
          -  athletes must be train or play five times in a week.&#xD;
&#xD;
          -  athletes must be participate in some official competition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous surgery (locomotor appareil).&#xD;
&#xD;
          -  discal herniation diagnosis.&#xD;
&#xD;
          -  nerve root entrapment.&#xD;
&#xD;
          -  spondylolisis.&#xD;
&#xD;
          -  spondylolisthesis;&#xD;
&#xD;
          -  lumbar stenosis.&#xD;
&#xD;
          -  hip cartilage damage.&#xD;
&#xD;
          -  labral injury,&#xD;
&#xD;
          -  piriformis syndrome.&#xD;
&#xD;
          -  neurological disease.&#xD;
&#xD;
          -  no current treatment in Physiotherapy or Pilates or Manual Therapy.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rubens da Silva, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Laboratory of Functional Assessment and Human Motor Performance (LAFUP)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory of Functional Assessment and Human Motor Performance (LAFUP)</name>
      <address>
        <city>Londrina</city>
        <state>Paraná</state>
        <zip>86041-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015 Dec;29(12):1155-67. doi: 10.1177/0269215515570379. Epub 2015 Feb 13.</citation>
    <PMID>25681408</PMID>
  </reference>
  <reference>
    <citation>Moon HJ, Choi KH, Kim DH, Kim HJ, Cho YK, Lee KH, Kim JH, Choi YJ. Effect of lumbar stabilization and dynamic lumbar strengthening exercises in patients with chronic low back pain. Ann Rehabil Med. 2013 Feb;37(1):110-7. doi: 10.5535/arm.2013.37.1.110. Epub 2013 Feb 28.</citation>
    <PMID>23525973</PMID>
  </reference>
  <reference>
    <citation>Cairns MC, Foster NE, Wright C. Randomized controlled trial of specific spinal stabilization exercises and conventional physiotherapy for recurrent low back pain. Spine (Phila Pa 1976). 2006 Sep 1;31(19):E670-81. doi: 10.1097/01.brs.0000232787.71938.5d.</citation>
    <PMID>16946640</PMID>
  </reference>
  <reference>
    <citation>McGill SM, Karpowicz A. Exercises for spine stabilization: motion/motor patterns, stability progressions, and clinical technique. Arch Phys Med Rehabil. 2009 Jan;90(1):118-26. doi: 10.1016/j.apmr.2008.06.026.</citation>
    <PMID>19154838</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Norte do Paraná</investigator_affiliation>
    <investigator_full_name>Rubens Alexandre da Silva Jr</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Postural control</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Sports injuries</keyword>
  <keyword>Low back pain</keyword>
  <keyword>training</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>
    <mesh_term>Athletic Injuries</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/NCT02969785
org study id: Rubens A. da Silva
nct id: NCT02969785
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The relevance of this study is given by the feasibility to assess the effect of an
      intervention program based on the postural control and trunk neuromuscular activity,
      comparing two methods: stabilization exercises vs. back strengthening exercises, in athletes
      with low back pain. The main outcomes will be computed by electromyography measurement so
      that to assess the trunk neuromuscular activation pattern as well as by force platform
      parameters for determining of postural control. Clinical symptoms such as pain intensity,
      perception of disability and fear and avoidance will also be computed. This is the first
      study to compare two intervention methods using the main biological outcomes related to trunk
      neuromuscular function.
For this study, a proposal of a 8-week intervention program will be carried out with lumbar
      stabilization exercises and back strengthening exercises, in 32 athletes with chronic low
      back, recruited by convenience and voluntaries from the community local and sports centers.
      Before intervention, all participantes will be evaluated by: electromoyography during back
      endurance and strength tests, balance performance, physical capacity, and by clinical
      outcomes such as pain, disability and psychological factors. All baseline testing and
      evaluation will be performed by a blinded evaluator to the study intervention. Afterwards,
      the participants will be randomized in two groups by a blinded evaluator (people not enroled
      to study): G1: exercises for lumbar stabilization; and G2: strengthening exercises. The
      intervention will follow 8 weeks, with 50 minutes of duration each session of therapy
      including measurement of blood pressure, heart rate and the Visual Analogue Scale (VAS)
      before and after each session, and the perception of exercise intensity monitored by Borg
      Scale. Within this proposal, the exercise sessions will performed twice a week. The
      intervention will follow the CONSORT recommendations for randomized controlled trials. The
      intervention will start in: G1 (n=16, motor control group), which will perform therapy with
      specific exercises for lumbar stabilization including the Swiss ball as therapeutic resource;
      while G2 (n=16, strength group) will perform back endurance progressive and resisted
      exercises on a Roman chair. The participants will not be blind to the study due to the
      characteristic of the exercises that often reflect to the improvement of the symptoms. In
      case of eventual losses, the intention-to-treat method will be used for the analyses. After
      the intervention, all groups will be invited to come back to the laboratory to proceed the
      same evaluation from baseline (trunk activation during exercises, balance, and clinical
      outcomes). For the analysis two-way ANOVA with repeated measures will be performed to compare
      the effects of the intervention (two groups) and times (baseline vs. end 8-weeks measurement)
      and the effects of interaction (Groups x Times). The size effect also will be computed to
      determine the rate of the changes observed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Eletromyography measurement
time frame: Change from baseline muscular activation at 8 weeks
description: EMG estimates, Root Mean Square: RMS (in microvolts unit: uV) and Median Frequency: MF (in Hertz: Hz) will be computed to evaluate the back activation during strength maximal protocol and endurance dynamic test.
measure: Force platform measurement
time frame: Change from baseline muscular activation at 8 weeks
description: Force platform measurement during balance performance using centre of pressure measures to assess balance performance.
measure: Visual Analogic Scale
time frame: Change from baseline muscular activation at 8 weeks
description: Pain measurement using Short Version of Pain Questionnaire McGill (score 0 to 78; while higher score is determined by poor condition related to pain) and Visual Analogue Scale for pain intensity (score of 0 to 10 intensity; being 10 of poor score for VAS).
measure: Disability questionnaire
time frame: Change from baseline muscular activation at 8 weeks
description: Disability measurement using Oswestry questionnaire.
measure: Fear-avoidance questionnaire
time frame: Change from baseline muscular activation at 8 weeks
description: Fear-avoidance model measurement using Waddel questionnaire related to work and physical activity.
arm group label: G1: exercises for lumbar stabilization
arm group type: Experimental
description: Specific exercises for lumbar stabilization. The Group 1 (G1) will perform therapy with specific exercises for lumbar stabilization whith the Swiss ball as a therapeutic resource, including warming; stretching of hamstrings, paraspinals, trapezes; phasic perineal exercise; tonic perineal exercise; pelvic lumbar synergism; trunk mobility; mobility of the shoulder girdle; balance; and slow pelvic balance.
arm group label: G2: back strengthening exercises
arm group type: Active Comparator
description: Back strengthening exercises. The Group 2 (G2) will perform therapy including strengthning of back muscles on a Roman chair machine for flexion and extension of trunk with load progression from training volume for endurance and strength gains.
intervention type: Other
intervention name: G1: exercises for lumbar stabilization
description: Specific exercises for lumbar stabilization. The Group 1 (G1) will perform therapy with specific exercises for lumbar stabilization whith the Swiss ball as a therapeutic resource, including warming; stretching of hamstrings, paraspinals, trapezes; phasic perineal exercise; tonic perineal exercise; pelvic lumbar synergism; trunk mobility; mobility of the shoulder girdle; balance; and slow pelvic balance.
arm group label: G1: exercises for lumbar stabilization
other name: therapeutic exercises
intervention type: Other
intervention name: G2: back strengthening exercises
description: Specific back exercises. The Group 2 (G2) will perform therapy including back strengthing exercise on a Roman chair machine to perform flexion and extension of trunk with load progressive training.
arm group label: G2: back strengthening exercises
other name: Back resistive training
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rubens da Silva, PhD
role: Study Director
affiliation: Laboratory of Functional Assessment and Human Motor Performance (LAFUP)
facility: 
country: Brazil
citation: Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015 Dec;29(12):1155-67. doi: 10.1177/0269215515570379. Epub 2015 Feb 13.
PMID: 25681408
citation: Moon HJ, Choi KH, Kim DH, Kim HJ, Cho YK, Lee KH, Kim JH, Choi YJ. Effect of lumbar stabilization and dynamic lumbar strengthening exercises in patients with chronic low back pain. Ann Rehabil Med. 2013 Feb;37(1):110-7. doi: 10.5535/arm.2013.37.1.110. Epub 2013 Feb 28.
PMID: 23525973
citation: Cairns MC, Foster NE, Wright C. Randomized controlled trial of specific spinal stabilization exercises and conventional physiotherapy for recurrent low back pain. Spine (Phila Pa 1976). 2006 Sep 1;31(19):E670-81. doi: 10.1097/01.brs.0000232787.71938.5d.
PMID: 16946640
citation: McGill SM, Karpowicz A. Exercises for spine stabilization: motion/motor patterns, stability progressions, and clinical technique. Arch Phys Med Rehabil. 2009 Jan;90(1):118-26. doi: 10.1016/j.apmr.2008.06.026.
PMID: 19154838
responsible party type: Principal Investigator
investigator affiliation: Universidade Norte do Paraná
investigator full name: Rubens Alexandre da Silva Jr
investigator title: Professor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Athletic Injuries
sharing ipd: No