Musculoskeletal PainNCT07274540
Use Of Orthotics To Reduce Pain In Musicians
A study testing Foream Band Orthosis in people with Musculoskeletal Pain and Overuse Syndrome, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Musculoskeletal Pain, Overuse Syndrome, Tendinopathy, Elbow
- What is being tested?
- Foream Band Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2020to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Musculoskeletal Pain, Overuse Syndrome, Tendinopathy, Elbow, Musculoskeletal Pain and Functional Impairment in Musicians
- Being tested
- Foream Band Orthosis
- Keywords
- Forearm Orthosis, Musician's Pain, Grip Strength, Evaluation, Instrument, Pain
- Medical subject headings
- Musculoskeletal Pain, Cumulative Trauma Disorders, Elbow Tendinopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foream Band OrthosisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Foream Band Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks
Secondary outcomes (1)
Change from Baseline in Quality of Life (SF-36)
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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start16 Jan 2020
- Primary completion28 Feb 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba YILDIZ, Medipol University
- Investigators
- Tuba Yıldız, Lecturer, PhD student, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274540
- Sponsor's protocol ID
- 10840098-604.01.01-E.1378
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Front Arm Band Orthosis On Pain, Functionalite And Grip Force Evaluation To Person Of Play Instrument
- ClinicalTrials.gov ID
- NCT07274540
- Acronym / sponsor ID
- 10840098-604.01.01-E.1378
- Conditions
- Musculoskeletal Pain, Overuse Syndrome, Tendinopathy, Elbow, Musculoskeletal Pain and Functional Impairment in Musicians
- Keywords
- Forearm Orthosis, Musician's Pain, Grip Strength, Evaluation, Instrument, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthosis Group | Experimental | Device: Foream Band OrthosisAll 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foream Band OrthosisThe 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. | Device | Orthosis Group |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Change from Baseline in Quality of Life (SF-36)
Time frame: Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuba Yıldız, Lecturer, PhD student principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foream Band Orthosis in people with Musculoskeletal Pain and Overuse Syndrome, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain Intensity as Measured by the Visual Analog Scale (VAS) (time frame: Baseline and 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.