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NCT Number: NCT07274540

Use Of Orthotics To Reduce Pain In Musicians

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.

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Key information

Conditions

Musculoskeletal Pain Arm Injuries Cumulative Trauma Disorders Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain and Functional Impairment in Musicians Neurologic Manifestations Overuse Syndrome Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sprains and Strains Tendinopathy Tendinopathy, Elbow Tendon Injuries Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

The Effects Of Front Arm Band Orthosis On Pain, Functionalite And Grip Force Evaluation To Person Of Play Instrument

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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