Clinical trial NCT03837106: Workplace Rehabilitation for Musicians: Program Optimisation and Evaluation
Official title: Workplace Rehabilitation of Musculoskeletal Disorders in Professional Musicians: Program Optimisation and Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorder
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Full-time classical musician with or without musculoskeletal pain, student or professional
* ≥18 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in the Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians (MPIIQM) at 12 months
timeFrame: Baseline, 1 year
Secondary outcomes:
measure: Change in symptom prevalence and frequency from baseline: Nordic Musculoskeletal Questionnaire at 12 months
timeFrame: Baseline, 1 year
measure: Changes in health-related behaviour from baseline: Self-Assessment Questionnaire at 12 months
timeFrame: Baseline, 1 year
measure: Perceived change of condition from baseline: Global Rating of Change
timeFrame: 1 year
measure: Change in symptom frequency from baseline: Symptom frequency scale at 12 months
timeFrame: Baseline,1 year
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CIRRIS
state: Quebec
Study officials:
affiliation: Laval University
name: Jean-Sébastien Roy, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: