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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03837106
Other study ID # Musicians: RCT program #2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 18, 2019
Est. completion date December 23, 2020

Study information

Verified date October 2023
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date December 23, 2020
Est. primary completion date December 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Rehabilitation program
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.

Locations

Country Name City State
Canada CIRRIS Québec Quebec

Sponsors (1)

Lead Sponsor Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, 1 year
Secondary 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 Baseline, 1 year
Secondary 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 Baseline, 1 year
Secondary Perceived change of condition from baseline: Global Rating of Change Self-report questionnaire evaluating participants' perceived change over the course of the study 1 year
Secondary 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 Baseline,1 year
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