- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07274540
Use Of Orthotics To Reduce Pain In Musicians
December 10, 2025 updated by: Tuba YILDIZ, Medipol University
The Effects Of Front Arm Band Orthosis On Pain, Functionalite And Grip Force Evaluation To Person Of Play Instrument
This interventional clinical study investigates the effectiveness of applying a forearm strap orthosis in 30 individuals experiencing forearm pain due to playing a musical instrument.
Participants used the orthosis for 4 weeks.
The primary objective is to evaluate the changes in pain levels and grip strength following this period.
The study also explores the potential of this intervention to improve functionality and quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The therapeutic and biomechanical effects of orthoses are utilized in the management of musculoskeletal disorders frequently encountered in instrumental musicians; this interventional study aims to prospectively evaluate the effect of a standardized forearm strap orthosis intervention on pain intensity, grip strength, and upper extremity functionality after a 4-week usage period in instrumental musicians.
The study employs an Interventional type, single-group assignment, non-randomized pre-post design, enrolling 30 individuals from the Sulukule Art Academy of Fatih Municipality who meet the inclusion criteria.
The primary outcome measures are the McGill Melzack Pain Questionnaire and Visual Analogue Scale (VAS) scores, grip strength values measured with the Jamar dynamometer, and Disabilities of the Arm, Shoulder, and Hand (DASH-T) Questionnaire scores, all obtained pre- and post- orthosis use.
The secondary outcome measure is the evaluation of quality of life using the Short Form 36 (SF-36) Quality of Life Survey.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beykoz
-
Istanbul, Beykoz, Turkey (Türkiye), 34810
- Medipol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants were between 18 and 55 years old at the time of enrollment.
- Participants had been playing an instrument for more than six months.
- Participants had been playing an instrument for at least one hour a day.
- Participants were willing and able to adapt to orthotic treatment.
Exclusion Criteria:
- Participants had a history of surgery and/or trauma to the elbow where orthosis treatment was required.
- Participants were receiving physiotherapy treatment within the last 6 months.
- Participants had an acute injury that prevented performance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Orthosis Group
All participants received the Forearm Strap Orthosis intervention for a total period of 4 weeks.
Measurements for primary and secondary outcomes were collected at baseline (pre-intervention) and immediately following the 4-week orthosis usage period (post-intervention).
Data collection for this single-group intervention study was completed in 2020.
|
The Forearm Band Orthosis was applied and used by participants for 4 weeks during instrumental music playing sessions and daily activities.
The orthosis aimed to provide counterforce to the muscle tendon unit to reduce tension at the epicondyle and alleviate pain associated with repetitive strain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Isometric Grip Strength using Jamar Dynamometer
Time Frame: Baseline and 4 weeks
|
The maximum isometric grip strength of the affected hand was measured using the Jamar Dynamometer device.
|
Baseline and 4 weeks
|
|
Change from Baseline in Upper Extremity Functional Status using the Disabilities of the Arm, Shoulder, and Hand (DASH-T) Score
Time Frame: Baseline and 4 weeks
|
It was a standardized questionnaire that measured upper extremity disability and its symptoms.
A decrease in the DASH-T score (increased functionality) was evaluated.
|
Baseline and 4 weeks
|
|
Change from Baseline in Pain Intensity as Measured by the Visual Analog Scale (VAS)
Time Frame: Baseline and 4 weeks
|
The VAS was a valid measure that recorded participants' perceived pain intensity.
A decrease in the VAS score was evaluated.
VAS ranges from a minimum of 0 (no pain) to a maximum of 10 (the most severe pain imaginable); higher scores indicate worse (more severe) pain.
|
Baseline and 4 weeks
|
|
Change from Baseline in Pain Experience Measured by the McGill Melzack Pain Questionnaire Score (MPQ-PRI)
Time Frame: Baseline and 4 weeks
|
It was a questionnaire that measured the sensory, emotional, and evaluative aspects of pain.
The decrease in the score was evaluated.
The MPQ-PRI ranges from a minimum of 0 (no pain) to a maximum of 78 (the most severe and comprehensive pain); higher scores indicate a worse and more multidimensional pain experience.
|
Baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Quality of Life (SF-36)
Time Frame: Baseline and 4 weeks
|
It was a survey that assessed the physical and mental components of quality of life.
The increase in the SF-36 score was evaluated.
The scores obtained from the form range from a minimum of 0 (poorest mental health and function) to a maximum of 100 (best function); higher scores indicate better physical and mental health and functioning.
|
Baseline and 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tuba Yıldız, Lecturer, PhD student, Medipol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 16, 2020
Primary Completion (Actual)
February 28, 2020
Study Completion (Actual)
March 30, 2020
Study Registration Dates
First Submitted
November 27, 2025
First Submitted That Met QC Criteria
November 27, 2025
First Posted (Estimated)
December 10, 2025
Study Record Updates
Last Update Posted (Actual)
December 18, 2025
Last Update Submitted That Met QC Criteria
December 10, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Elbow Injuries
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Wounds and Injuries
- Tendon Injuries
- Arm Injuries
- Tendinopathy
- Sprains and Strains
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Elbow Tendinopathy
- Pain
- Musculoskeletal Pain
- Cumulative Trauma Disorders
Other Study ID Numbers
- 10840098-604.01.01-E.1378
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data (IPD) will not be shared.
This decision is based on the informed consent provided by the participants, which did not grant permission for future data sharing beyond the scope of the original research project.
Additionally, the study's sponsor does not possess the institutional infrastructure or dedicated resources required to de-identify, host, and manage a controlled data access platform for external investigators.
The study results will be published in the scientific literature as aggregate data to ensure patient confidentiality and compliance with ethical approvals.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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