NCT03837106

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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2020

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

February 7, 2019

Last Update Submit

October 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in symptom prevalence and frequency from baseline: Nordic Musculoskeletal Questionnaire at 12 months

    Baseline, 1 year

  • Changes in health-related behaviour from baseline: Self-Assessment Questionnaire at 12 months

    Baseline, 1 year

  • Perceived change of condition from baseline: Global Rating of Change

    1 year

  • Change in symptom frequency from baseline: Symptom frequency scale at 12 months

    Baseline,1 year

Study Arms (2)

Rehabilitation program

EXPERIMENTAL

Home and supervised exercise program specific to musicians. Injury prevention and management education program specific to musicians.

Other: Rehabilitation program

No intervention

NO INTERVENTION

Control group, no intervention

Interventions

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.

Rehabilitation program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIRRIS

Québec, Quebec, G1M 2S8, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jean-Sébastien Roy, PT, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Rehabilitation Department

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 11, 2019

Study Start

February 18, 2019

Primary Completion

December 23, 2020

Study Completion

December 23, 2020

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations