Musculoskeletal DisorderNCT03837106
Workplace Rehabilitation for Musicians: Program Optimisation and Evaluation
A study testing Rehabilitation program in people with Musculoskeletal Disorder, run by Laval University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorder
- What is being tested?
- Rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 18 Feb 2019to 23 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Full-time classical musician with or without musculoskeletal pain, student or professional
- ≥18 years
Who cannot join
- musculoskeletal injuries non-related to musical performance
- <15 hours per week playing their instrument
- corticosteroid injection in the 6 weeks pre-recruitment
- prescribed anti-inflammatories or gabapentin in the 3 weeks pre-recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Workplace Rehabilitation of Musculoskeletal Disorders in Professional Musicians: Program Optimisation and Evaluation
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.
Read more
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:
- - 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.
- - 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.
- - 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.
- Conditions
- Musculoskeletal Disorder
- Being tested
- Rehabilitation program
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation program | Experimental | Home and supervised exercise program specific to musicians. Injury prevention and management education program specific to musicians. Receives: Other: Rehabilitation program |
| No intervention | No intervention | Control group, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians (MPIIQM) at 12 months
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.
Measured: Baseline, 1 year
Secondary outcomes (4)
Change in symptom prevalence and frequency from baseline: Nordic Musculoskeletal Questionnaire at 12 months
Self-report questionnaire evaluating symptom prevalence and frequency in all regions of the body
Measured: Baseline, 1 year
Changes in health-related behaviour from baseline: Self-Assessment Questionnaire at 12 months
Self-report questionnaire evaluating changes in health related behaviour over the course of the study
Measured: Baseline, 1 year
Perceived change of condition from baseline: Global Rating of Change
Self-report questionnaire evaluating participants' perceived change over the course of the study
Measured: 1 year
Change in symptom frequency from baseline: Symptom frequency scale at 12 months
Self-report questionnaire evaluating frequency of symptoms on a scale from 0 to 10
Measured: Baseline,1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start18 Feb 2019
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Sébastien Roy, Laval University
- Investigators
- Jean-Sébastien Roy, PT, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837106
- Sponsor's protocol ID
- Musicians: RCT program #2
- Status last verified
- Oct 2023
- First submitted
- 7 Feb 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roos M, Lamontagne ME, Desmeules F, Dionne C, Savard I, Pinard AM, Lafrance S, Tanguay M, Roy JS. Workplace Injury Prevention and Wellness Program for Orchestra Musicians: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2024 Sep;54(9):584-593. doi: 10.2519/jospt.2024.12277.
PubMed 39180194
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workplace Rehabilitation of Musculoskeletal Disorders in Professional Musicians: Program Optimisation and Evaluation
- ClinicalTrials.gov ID
- NCT03837106
- Acronym / sponsor ID
- Musicians: RCT program #2
- Conditions
- Musculoskeletal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- - 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.
- - 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.
- - 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation program | Experimental | Other: Rehabilitation programHome and supervised exercise program specific to musicians. Injury prevention and management education program specific to musicians. |
| No intervention | No intervention | –Control group, no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Full-time classical musician with or without musculoskeletal pain, student or professional
- ≥18 years
Key exclusion criteria (4 listed)
- musculoskeletal injuries non-related to musical performance
- <15 hours per week playing their instrument
- corticosteroid injection in the 6 weeks pre-recruitment
- prescribed anti-inflammatories or gabapentin in the 3 weeks pre-recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation program3-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. | Other | Rehabilitation program |
Primary outcome
Change from baseline in the Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians (MPIIQM) at 12 months
Time frame: Baseline, 1 year
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.
4 secondary outcomes
Change in symptom prevalence and frequency from baseline: Nordic Musculoskeletal Questionnaire at 12 months
Time frame: Baseline, 1 year
Changes in health-related behaviour from baseline: Self-Assessment Questionnaire at 12 months
Time frame: Baseline, 1 year
Perceived change of condition from baseline: Global Rating of Change
Time frame: 1 year
Change in symptom frequency from baseline: Symptom frequency scale at 12 months
Time frame: Baseline,1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39180194Roos M, Lamontagne ME, Desmeules F, Dionne C, Savard I, Pinard AM, Lafrance S, Tanguay M, Roy JS. Workplace Injury Prevention and Wellness Program for Orchestra Musicians: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2024 Sep;54(9):584-593. doi: 10.2519/jospt.2024.12277.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Sébastien Roy, PT, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program in people with Musculoskeletal Disorder, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03837106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023; AzTrials last refreshed its copy on 29 Oct 2026.