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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Foream Band Orthosis
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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