Ignite Creation Date:
2024-05-06 @ 12:45 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03837106
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2019-02-07
Brief Title:
Workplace Rehabilitation for Musicians Program Optimisation and Evaluation
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
Workplace Rehabilitation of Musculoskeletal Disorders in Professional Musicians Program Optimisation and Evaluation
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background The classical musicians 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None