SplintsNCT05731869
Investigation of the Effect of Epicondylitis Band and Wrist Orthosis
An observational study of Splints, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
Muscles that are frequently injured in the extensor group are extensor carpi radialis longus, extensor carpi radialis brevis, and extensor digitorum communis. Injury of these muscles is seen as lateral epicondylitis in the clinic. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Splints
- What is being tested?
- epicondylitis band and wrist orhosis
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 1 Sep 2022
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals
Who may be able to join
- Between 18-45 years old
- Right upper extremity dominant
- No upper extremity limitation in activities of daily living
- Volunteer individuals
Who cannot join
- With orthopedic, neurological and rheumatological problems in the upper extremity
- Entrapment neuropathy, TOS, cervical radiculopathy, and cervical disc herniation
- History of upper extremity injury or surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Epicondylitis Band and Wrist Orthosis on Extensor Muscle Activity and Upper Extremity Functions
Muscles that are frequently injured in the extensor group are extensor carpi radialis longus, extensor carpi radialis brevis, and extensor digitorum communis. Injury of these muscles is seen as lateral epicondylitis in the clinic. Physiotherapy techniques are frequently applied in the management of diseases related to forearm extensor muscles such as lateral epicondylitis. Various orthoses such as lateral epicondylitis band, wrist orthosis, dynamic extensor brace are used for this. Studies have been conducted on pain, hand function and orthosis satisfaction of different types of lateral epicondylitis orthoses, and the number of studies investigating the effects on muscle activation is insufficient.Therefore, the aim of the study is to examine the effects of different types of orthoses used for the forearm extensor group on extensor muscle activation and upper limb functions.
- Conditions
- Splints
- Being tested
- epicondylitis band, wrist orhosis
- Keywords
- surface electromyography, muscle activation, orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epicondylitis bandOther
An off-the-shelf lateral epicondylitis tape in S-M-L dimensions was used distal to the lateral epicondylitis.
wrist orhosisOther
Wrist orthosis of the shelf was used in sizes S-M-L, covering the hand and wrist.
| Study group | Role | What they receive |
|---|---|---|
| Control group | The group measured without the use of orthoses and tapes | |
| Epicondylitis Band Group | Group measured with epicondylitis band Receives: Other: epicondylitis band | |
| Wrist Orthosis Group | Group measured with wrist orthosis Receives: Other: wrist orhosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle activation
A superficial EMG system will be used to measure signals from the extensor carpi radialis longus/brevis and extensor carpi digitorum communis muscles.Electrodes will be placed according to SENIAM criteria.The signals received from the muscles of the individuals will be recorded during grasping. As a result, the average muscle activations of the muscles during the activity will be numerically recorded in %MVIC.
Measured: one hour
Secondary outcomes (2)
hand function
Jebson Taylor Hand Function Test, which includes daily life activities (writing, eating, etc.) and consists of 7 sub-parameters, was applied to measure hand function. The score is recorded in seconds and the score gets worse as the second increases.
Measured: one hour
satisfaction level
The OPUS questionnaire was used to measure the participants' orthotic satisfaction. The OPUS questionnaire evaluates the weight, durability, aesthetics, ease of putting on, skin and clothing problems, comfort, and the pain-reducing effect of the orthosis associated with the orthosis. The higher the score, the higher the level of satisfaction.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Jul 2021
- Primary completion1 Jan 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SplintsStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731869
- Sponsor's protocol ID
- 2021/058
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sari M, Ozturk D, Bek N. Comparison of two different orthoses used in the treatment of lateral epicondylitis. Prosthet Orthot Int. 2025 Feb 1;49(1):127-132. doi: 10.1097/PXR.0000000000000345. Epub 2024 Mar 22.
PubMed 38517366
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Epicondylitis Band and Wrist Orthosis on Extensor Muscle Activity and Upper Extremity Functions
- ClinicalTrials.gov ID
- NCT05731869
- Acronym / sponsor ID
- 2021/058
- Conditions
- Splints
- Keywords
- surface electromyography, muscle activation, orthosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 16 Feb 2023 (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.
Muscles that are frequently injured in the extensor group are extensor carpi radialis longus, extensor carpi radialis brevis, and extensor digitorum communis. Injury of these muscles is seen as lateral epicondylitis in the clinic. Physiotherapy techniques are frequently applied in the management of diseases related to forearm extensor muscles such as lateral epicondylitis. Various orthoses such as lateral epicondylitis band, wrist orthosis, dynamic extensor brace are used for this. Studies have been conducted on pain, hand function and orthosis satisfaction of different types of lateral epicondylitis orthoses, and the number of studies investigating the effects on muscle activation is insufficient.Therefore, the aim of the study is to examine the effects of different types of orthoses used for the forearm extensor group on extensor muscle activation and upper limb functions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –The group measured without the use of orthoses and tapes |
| Epicondylitis Band Group | – | Other: epicondylitis bandGroup measured with epicondylitis band |
| Wrist Orthosis Group | – | Other: wrist orhosisGroup measured with wrist orthosis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals
Key inclusion criteria (4 listed)
- Between 18-45 years old
- Right upper extremity dominant
- No upper extremity limitation in activities of daily living
- Volunteer individuals
Key exclusion criteria (3 listed)
- With orthopedic, neurological and rheumatological problems in the upper extremity
- Entrapment neuropathy, TOS, cervical radiculopathy, and cervical disc herniation
- History of upper extremity injury or surgery in the last 6 months
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 |
|---|---|---|
| epicondylitis bandAn off-the-shelf lateral epicondylitis tape in S-M-L dimensions was used distal to the lateral epicondylitis. | Other | Epicondylitis Band Group |
| wrist orhosisWrist orthosis of the shelf was used in sizes S-M-L, covering the hand and wrist. | Other | Wrist Orthosis Group |
Primary outcome
muscle activation
Time frame: one hour
A superficial EMG system will be used to measure signals from the extensor carpi radialis longus/brevis and extensor carpi digitorum communis muscles.Electrodes will be placed according to SENIAM criteria.The signals received from the muscles of the individuals will be recorded during grasping. As a result, the average muscle activations of the muscles during the activity will be numerically recorded in %MVIC.
2 secondary outcomes
hand function
Time frame: one hour
satisfaction level
Time frame: one hour
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 16 Feb 2023.
- Derived from this study: PubMed 38517366Sari M, Ozturk D, Bek N. Comparison of two different orthoses used in the treatment of lateral epicondylitis. Prosthet Orthot Int. 2025 Feb 1;49(1):127-132. doi: 10.1097/PXR.0000000000000345. Epub 2024 Mar 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Splints, run by Ankara Yildirim Beyazıt 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 16 Feb 2023. 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?
muscle activation (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05731869, which also lists 1 linked publication.
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 16 Feb 2023.