Use Of Orthotics To Reduce Pain In Musicians

NCT07274540 | Completed

• 1 other identifier: 10840098-604.01.01-E.1378
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Musculoskeletal Pain and Functional Impairment in Musicians; Musculoskeletal Pain; Overuse Syndrome; Tendinopathy, Elbow

Keywords

Forearm Orthosis; Musician's Pain; Grip Strength; Evaluation; Instrument; Pain

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Pain Intensity as Measured by the Visual Analog Scale (VAS)

  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)

  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

• Change from Baseline in Isometric Grip Strength using Jamar Dynamometer

  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

  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

Secondary Outcomes (1)

• Change from Baseline in Quality of Life (SF-36)

  Baseline and 4 weeks

Study Arms (1)

Orthosis Group

EXPERIMENTAL

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

Interventions

Foream Band Orthosis DEVICE

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.

Orthosis Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Cumulative Trauma Disorders; Elbow Tendinopathy; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sprains and Strains; Wounds and Injuries; Tendinopathy; Elbow Injuries; Arm Injuries; Tendon Injuries

Study Officials

• Tuba Yıldız, Lecturer, PhD student

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: January 16, 2020
• Primary Completion: February 28, 2020
• Study Completion: March 30, 2020
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)