<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/NCT03837106</url>
  </required_header>
  <id_info>
    <org_study_id>Musicians: RCT program #2</org_study_id>
    <nct_id>NCT03837106</nct_id>
  </id_info>
  <brief_title>Workplace Rehabilitation for Musicians: Program Optimisation and Evaluation</brief_title>
  <official_title>Workplace Rehabilitation of Musculoskeletal Disorders in Professional Musicians: Program Optimisation and Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laval University</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: The classical musician's work, which comprises numerous daily hours of precise&#xD;
      and often strenuous repetitive movements in asymmetrical postures, renders them vulnerable to&#xD;
      musculoskeletal (MSK) injury. Performance-related MSK disorders (PRMDs) have been defined as&#xD;
      &quot;any pain, weakness, numbness, tingling or other physical symptoms that interfere with your&#xD;
      ability to play your instrument at the level to which you are accustomed&quot;. The lifetime&#xD;
      prevalence of PRMDs in professional instrumental musicians ranges from 62 to 93%.&#xD;
      Furthermore, typical musical instruction does not include education on physical health and&#xD;
      injury prevention, and this is thought to be an important factor in musicians' development of&#xD;
      pain and injuries.&#xD;
&#xD;
      The combination of musician-specific exercise and education on injury prevention may have&#xD;
      greater impacts on musicians' wellbeing than exercise or education alone. In a pilot trial,&#xD;
      15 orchestral musicians were offered an educational presentation and carried out a home&#xD;
      exercise program for 11 weeks. There were no dropouts, exercise adherence was high and&#xD;
      musicians reported improvement of their symptoms. However, certain weaknesses were&#xD;
      identified. Thus, this type of rehabilitation program demonstrates much potential for&#xD;
      improving the wellbeing of orchestral musicians, but improvements should be made. The&#xD;
      collaboration of experts with relevant backgrounds, including musicians who were exposed to&#xD;
      the program, can optimize the program.&#xD;
&#xD;
      Objectives and hypotheses: The objectives are 1) to identify facilitators and obstacles to&#xD;
      the implementation of the initial program by realizing focus groups with musicians; 2) to&#xD;
      adapt the program to the local context; 3) to evaluate the effectiveness of the revised&#xD;
      program to decrease the intensity, functional impact and frequency of PRMDs in musicians with&#xD;
      a pilot randomised controlled trial (RCT); 4) to evaluate the effect of the educational&#xD;
      components of the program on health-related knowledge and behaviour. The hypothesis for&#xD;
      objective 3 is that a decrease in PRMD intensity, frequency and functional limitations will&#xD;
      be demonstrated in the experimental group following participation in the program, compared to&#xD;
      the control group.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
        1. - Focus groups: The 15 pilot project participants will be invited to share their&#xD;
           perceptions regarding the initial program. Sessions will be comprised of questions on&#xD;
           implementation determinants described in the Consolidated Framework for Implementation&#xD;
           Research.&#xD;
&#xD;
        2. - Adaptation to local context: Experts in education and exercise will design the&#xD;
           components of the program according to results from Step 1. All new or modified&#xD;
           exercises will be reviewed by two clinicians, and tried by participants from the pilot&#xD;
           trial. New comments will be considered, and an adapted program will be proposed.&#xD;
&#xD;
        3. - Implementation and evaluation of effectiveness Participants: Fifty orchestral&#xD;
           musicians (25 per group) will be recruited from full and part-time orchestras and&#xD;
           university-level music performance programs. Students will be included because the&#xD;
           program will have the potential to directly impact the workers of tomorrow. Musicians&#xD;
           with and without PRMDs will be invited to participate, as the program is both preventive&#xD;
           and curative.&#xD;
&#xD;
      Study design: Pilot single-blind RCT with 1-year follow-up. Participants will be evaluated at&#xD;
      baseline (T0), at the end of the 3-month rehabilitation program (T1) and 1 year later (T2).&#xD;
      The baseline evaluation will consist of questionnaires on PRMD symptoms and functional&#xD;
      limitations. Following baseline, subjects will be randomly assigned to either a&#xD;
      rehabilitation program (exercise group) or no intervention (control group). Randomization&#xD;
      will be stratified by instrument group and PRMD prevalence (presence or absence of symptoms).&#xD;
      The same questionnaires will be completed by all participants at evaluations 2 and 3. All&#xD;
      meetings will be held in participants' workplace.&#xD;
&#xD;
      Intervention: The rehabilitation program will consist of education on healthy practice habits&#xD;
      and load and injury management and a 3-month home exercise program specific to musicians.&#xD;
      Control group members will receive no intervention until after T2.&#xD;
&#xD;
      Baseline demographics will be compared between groups (independent t-tests, chi-square&#xD;
      tests). Two-way mixed-model analyses of variance (ANOVA) will explore the effect of the&#xD;
      rehabilitation program on PRMD symptoms and functional limitations.&#xD;
&#xD;
      Relevance: Orchestral musicians frequently suffer from debilitating pain that can have a&#xD;
      lasting impact on their career. Our multi-sectorial research and clinical team hopes to&#xD;
      create an effective rehabilitation program that can be offered to many musical populations.&#xD;
      If the program is effective, next steps will include integration of the program into the&#xD;
      workplace. In order to have longer-lasting and further-reaching impacts on musicians'&#xD;
      wellbeing, the presence of rehabilitation in the workplace is the ultimate goal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Anticipated">December 17, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 17, 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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians (MPIIQM) at 12 months</measure>
    <time_frame>Baseline, 1 year</time_frame>
    <description>Self-report questionnaire containing two subscales: Pain Intensity (4 questions) and Pain Interference (5 questions). Each question is scored by the participant on a scale from 0 (&quot;no pain&quot; or &quot;does not interfere&quot; to 10 &quot;pain as bad as you can imagine&quot; or &quot;completely interferes&quot; for Pain Intensity and Pain Interference, respectively. The pain intensity scale ranges from 0 to 40, and pain interference from 0 to 50, for a possible total of 90 points (summation) where higher scores indicate worse outcomes and lower scores indicate better outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in symptom prevalence and frequency from baseline: Nordic Musculoskeletal Questionnaire at 12 months</measure>
    <time_frame>Baseline, 1 year</time_frame>
    <description>Self-report questionnaire evaluating symptom prevalence and frequency in all regions of the body</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health-related behaviour from baseline: Self-Assessment Questionnaire at 12 months</measure>
    <time_frame>Baseline, 1 year</time_frame>
    <description>Self-report questionnaire evaluating changes in health related behaviour over the course of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived change of condition from baseline: Global Rating of Change</measure>
    <time_frame>1 year</time_frame>
    <description>Self-report questionnaire evaluating participants' perceived change over the course of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in symptom frequency from baseline: Symptom frequency scale at 12 months</measure>
    <time_frame>Baseline,1 year</time_frame>
    <description>Self-report questionnaire evaluating frequency of symptoms on a scale from 0 to 10</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Musculoskeletal Disorder</condition>
  <arm_group>
    <arm_group_label>Rehabilitation program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Home and supervised exercise program specific to musicians. Injury prevention and management education program specific to musicians.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group, no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation program</intervention_name>
    <description>3-month rehabilitation program comprising exercise and education specific to musicians. The program will be supported by an online platform containing more than 50 exercise videos, narrated powerpoint presentations, informative videos, quizzes, and forums for communicating with a physiotherapist and for organizing group exercise sessions.</description>
    <arm_group_label>Rehabilitation program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Full-time classical musician with or without musculoskeletal pain, student or&#xD;
             professional&#xD;
&#xD;
          -  ≥18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  musculoskeletal injuries non-related to musical performance&#xD;
&#xD;
          -  &lt;15 hours per week playing their instrument&#xD;
&#xD;
          -  corticosteroid injection in the 6 weeks pre-recruitment&#xD;
&#xD;
          -  prescribed anti-inflammatories or gabapentin in the 3 weeks pre-recruitment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Sébastien Roy, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laval University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marianne Roos, MPT</last_name>
    <phone>418-529-9141</phone>
    <phone_ext>6127</phone_ext>
    <email>marianne.roos.1@ulaval.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>CIRRIS</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1M 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marianne Roos, MPT</last_name>
      <phone>418-529-9141</phone>
      <phone_ext>6127</phone_ext>
      <email>marianne.roos.1@ulaval.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 19, 2021</last_update_submitted>
  <last_update_submitted_qc>February 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Jean-Sébastien Roy</investigator_full_name>
    <investigator_title>Associate Professor, Rehabilitation Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03837106
org study id: Musicians: RCT program #2
nct id: NCT03837106
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: The classical musician's work, which comprises numerous daily hours of precise
      and often strenuous repetitive movements in asymmetrical postures, renders them vulnerable to
      musculoskeletal (MSK) injury. Performance-related MSK disorders (PRMDs) have been defined as
      "any pain, weakness, numbness, tingling or other physical symptoms that interfere with your
      ability to play your instrument at the level to which you are accustomed". The lifetime
      prevalence of PRMDs in professional instrumental musicians ranges from 62 to 93%.
      Furthermore, typical musical instruction does not include education on physical health and
      injury prevention, and this is thought to be an important factor in musicians' development of
      pain and injuries.

      The combination of musician-specific exercise and education on injury prevention may have
      greater impacts on musicians' wellbeing than exercise or education alone. In a pilot trial,
      15 orchestral musicians were offered an educational presentation and carried out a home
      exercise program for 11 weeks. There were no dropouts, exercise adherence was high and
      musicians reported improvement of their symptoms. However, certain weaknesses were
      identified. Thus, this type of rehabilitation program demonstrates much potential for
      improving the wellbeing of orchestral musicians, but improvements should be made. The
      collaboration of experts with relevant backgrounds, including musicians who were exposed to
      the program, can optimize the program.

      Objectives and hypotheses: The objectives are 1) to identify facilitators and obstacles to
      the implementation of the initial program by realizing focus groups with musicians; 2) to
      adapt the program to the local context; 3) to evaluate the effectiveness of the revised
      program to decrease the intensity, functional impact and frequency of PRMDs in musicians with
      a pilot randomised controlled trial (RCT); 4) to evaluate the effect of the educational
      components of the program on health-related knowledge and behaviour. The hypothesis for
      objective 3 is that a decrease in PRMD intensity, frequency and functional limitations will
      be demonstrated in the experimental group following participation in the program, compared to
      the control group.

      Methods:

        1. - Focus groups: The 15 pilot project participants will be invited to share their
           perceptions regarding the initial program. Sessions will be comprised of questions on
           implementation determinants described in the Consolidated Framework for Implementation
           Research.

        2. - Adaptation to local context: Experts in education and exercise will design the
           components of the program according to results from Step 1. All new or modified
           exercises will be reviewed by two clinicians, and tried by participants from the pilot
           trial. New comments will be considered, and an adapted program will be proposed.

        3. - Implementation and evaluation of effectiveness Participants: Fifty orchestral
           musicians (25 per group) will be recruited from full and part-time orchestras and
           university-level music performance programs. Students will be included because the
           program will have the potential to directly impact the workers of tomorrow. Musicians
           with and without PRMDs will be invited to participate, as the program is both preventive
           and curative.

      Study design: Pilot single-blind RCT with 1-year follow-up. Participants will be evaluated at
      baseline (T0), at the end of the 3-month rehabilitation program (T1) and 1 year later (T2).
      The baseline evaluation will consist of questionnaires on PRMD symptoms and functional
      limitations. Following baseline, subjects will be randomly assigned to either a
      rehabilitation program (exercise group) or no intervention (control group). Randomization
      will be stratified by instrument group and PRMD prevalence (presence or absence of symptoms).
      The same questionnaires will be completed by all participants at evaluations 2 and 3. All
      meetings will be held in participants' workplace.

      Intervention: The rehabilitation program will consist of education on healthy practice habits
      and load and injury management and a 3-month home exercise program specific to musicians.
      Control group members will receive no intervention until after T2.

      Baseline demographics will be compared between groups (independent t-tests, chi-square
      tests). Two-way mixed-model analyses of variance (ANOVA) will explore the effect of the
      rehabilitation program on PRMD symptoms and functional limitations.

      Relevance: Orchestral musicians frequently suffer from debilitating pain that can have a
      lasting impact on their career. Our multi-sectorial research and clinical team hopes to
      create an effective rehabilitation program that can be offered to many musical populations.
      If the program is effective, next steps will include integration of the program into the
      workplace. In order to have longer-lasting and further-reaching impacts on musicians'
      wellbeing, the presence of rehabilitation in the workplace is the ultimate goal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change from baseline in the Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians (MPIIQM) at 12 months
time frame: Baseline, 1 year
description: Self-report questionnaire containing two subscales: Pain Intensity (4 questions) and Pain Interference (5 questions). Each question is scored by the participant on a scale from 0 ("no pain" or "does not interfere" to 10 "pain as bad as you can imagine" or "completely interferes" for Pain Intensity and Pain Interference, respectively. The pain intensity scale ranges from 0 to 40, and pain interference from 0 to 50, for a possible total of 90 points (summation) where higher scores indicate worse outcomes and lower scores indicate better outcomes.
measure: Change in symptom prevalence and frequency from baseline: Nordic Musculoskeletal Questionnaire at 12 months
time frame: Baseline, 1 year
description: Self-report questionnaire evaluating symptom prevalence and frequency in all regions of the body
measure: Changes in health-related behaviour from baseline: Self-Assessment Questionnaire at 12 months
time frame: Baseline, 1 year
description: Self-report questionnaire evaluating changes in health related behaviour over the course of the study
measure: Perceived change of condition from baseline: Global Rating of Change
time frame: 1 year
description: Self-report questionnaire evaluating participants' perceived change over the course of the study
measure: Change in symptom frequency from baseline: Symptom frequency scale at 12 months
time frame: Baseline,1 year
description: Self-report questionnaire evaluating frequency of symptoms on a scale from 0 to 10
arm group label: Rehabilitation program
arm group type: Experimental
description: Home and supervised exercise program specific to musicians. Injury prevention and management education program specific to musicians.
arm group label: No intervention
arm group type: No Intervention
description: Control group, no intervention
intervention type: Other
intervention name: Rehabilitation program
description: 3-month rehabilitation program comprising exercise and education specific to musicians. The program will be supported by an online platform containing more than 50 exercise videos, narrated powerpoint presentations, informative videos, quizzes, and forums for communicating with a physiotherapist and for organizing group exercise sessions.
arm group label: Rehabilitation program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Sébastien Roy, PT, PhD
role: Principal Investigator
affiliation: Laval University
last name: Marianne Roos, MPT
phone: 418-529-9141
phone ext: 6127
email: marianne.roos.1@ulaval.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Jean-Sébastien Roy
investigator title: Associate Professor, Rehabilitation Department
mesh term: Musculoskeletal Diseases