Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001398897p
Ethics application status
Submitted, not yet approved
Date submitted
3/03/2021
Date registered
18/10/2021
Date last updated
18/10/2021
Date data sharing statement initially provided
18/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of therapeutic exercise on pain, quality of life and musical performance in instrumentalist musicians. Randomised Clinical trial.
Scientific title
The impact of therapeutic exercise in pain, quality of life and musical performance in instrumentalist musicians. Randomised Clinical trial.
Secondary ID [1] 303594 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
musculoskeletal pain 320962 0
central sensitization 320963 0
quality of life 320964 0
physical wellbeing 320966 0
Condition category
Condition code
Musculoskeletal 318772 318772 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 318773 318773 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is intended to last nine months for both groups, both interventional and control.
The interventional group will undergo a therapeutic exercise program during nine months, twice a week, which will be conducted by a specialized physiotherapist. Each session will have a 45 minute-duration and the physiotherapist will provide with the necessary materials to carry out the exercises. The treatment will be conducted face to face in the conservatories of the provinces of Huelva and Seville (Andalucía, Spain).
Therapeutic exercises will consist in specific exercises to train the muscles involved in the practice of the instruments: upper limb muscles stretching, movilizations to improve the range of movement and exiercises to increase force an endurance.
The mode of administration of the therapeutic exercise will be individual for each participant.
The level of intensity of the therapeutic exercise will depend on the participant´s general phisical condition. It will be assessed by the Borg RPE scale.
Adherence will be monitored by session attendance checklists.
The participants involved in the interventional group will also receive a monthly one-hour educational talk about exercise, body awareness, musculoskeletal pain, neurological pain approaches and advice to improve musical performance. This talk will be administered in groups of 20 participants, and the attendance will be checked by the use of a list.
Intervention code [1] 319881 0
Rehabilitation
Intervention code [2] 319882 0
Treatment: Other
Comparator / control treatment
The participants involved in the control group will receive a monthly one-hour educational talk about exercise, body awareness, musculoskeletal pain, neurological pain approaches and advice to improve musical performance.
The study is intended to last nine months for both groups, both interventional and control.
Control group
Active

Outcomes
Primary outcome [1] 326719 0
Change in musculoskeletal pain. Assessed with the VAS scale and the Nordic Musculoskeletal Questionnaire
Timepoint [1] 326719 0
Baseline, 3, 6 and 9 months after the intervention commencement (primary endpoint); and 3 months after the intervention conclusion.
Primary outcome [2] 326720 0
Change in Quality of life. Assessed with SF-36 Health Assessment Questionnaire.
Timepoint [2] 326720 0
Baseline, 3, 6 and 9 months after the intervention commencement (primary endpoint); and 3 months after the intervention conclusion.
Secondary outcome [1] 392466 0
Change in musical performance. Assessed with a face to face interview (qualitative assessment) in which the participant will describe if he/she still has disturbing symptoms. .
Timepoint [1] 392466 0
Baseline, 3, 6 and 9 months after the intervention commencement; and 3 months after the intervention conclusion.

Eligibility
Key inclusion criteria
Instrumentalist musicians (both professional and students)
Musculoskeletal pain caused by musical instrument practice
Reduced musical performance
Minimum age
14 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Musical Instrument conservatory classes duration less than 1 hour a week.
Music instrument practice less than 1 daily hour.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Size sample will be determined by using the G Power 3.1.9.4 software, assuming an alpha error of 0’05, a Beta error of 0’1, a desirable size effect of 0’08 and a statistical power of 0’9.
Under these conditions, the sample needed is a total of 56 participants for both groups. In prevention of sample losses the size will be increased in a 10%, which results in a total of 62 participants, 31 for each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/01/2022
Actual
Date of last participant enrolment
Anticipated
17/09/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment outside Australia
Country [1] 23497 0
Spain
State/province [1] 23497 0
SEVILLA

Funding & Sponsors
Funding source category [1] 308016 0
Self funded/Unfunded
Name [1] 308016 0
CRISTINA IGLESIAS CARRASCO
Country [1] 308016 0
Spain
Primary sponsor type
Individual
Name
CRISTINA IGLESIAS CARRASCO
Address
Faculty of Nursing, Physiotherapy and Podiatry
Avenzoar St., 6
41009 Seville
Spain
Country
Spain
Secondary sponsor category [1] 308738 0
Individual
Name [1] 308738 0
ESTHER MARÍA MEDRANO SÁNCHEZ
Address [1] 308738 0
Faculty of Nursing, Physiotherapy and Podiatry Avenzoar St., 6 41009 Seville Spain
Country [1] 308738 0
Spain

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308006 0
PEIBA PORTAL DE BIOÉTICA DE ANDALUCIA
Ethics committee address [1] 308006 0
Ethics committee country [1] 308006 0
Spain
Date submitted for ethics approval [1] 308006 0
19/07/2021
Approval date [1] 308006 0
Ethics approval number [1] 308006 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109206 0
Miss CRISTINA IGLESIAS CARRASCO
Address 109206 0
Faculty of Nursing, Physiotherapy and Podiatry Avenzoar St. 6 41009 Seville Spain
Country 109206 0
Spain
Phone 109206 0
+0034 669023953
Fax 109206 0
Email 109206 0
[email protected]
Contact person for public queries
Name 109207 0
ESTHER MARÍA MEDRANO SÁNCHEZ
Address 109207 0
Faculty of Nursing, Physiotherapy and Podiatry Avenzoar St. 6 41009 Seville Spain
Country 109207 0
Spain
Phone 109207 0
+0034 609076282
Fax 109207 0
+0034 954486527
Email 109207 0
[email protected]
Contact person for scientific queries
Name 109208 0
ESTHER MARÍA MEDRANO SÁNCHEZ
Address 109208 0
Faculty of Nursing, Physiotherapy and Podiatry Avenzoar St. 6 41009 Seville Spain
Country 109208 0
Spain
Phone 109208 0
+0034 609076282
Fax 109208 0
+0034 954486527
Email 109208 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual data will be shared after publishing the results.

What types of analyses could be done with individual participant data?
• For IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, and available for 2 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• By email to [email protected] or [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10878Statistical analysis plan  [email protected]


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.