Carpal Tunnel SyndromeNCT06514625
Sleep Quality in Carpal Tunnel Syndrome, Splinting and Kinesiotaping
A study testing splint in people with Carpal Tunnel Syndrome, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The effect of conservative treatments on sleep quality in carpal tunnel syndrome is unclear. Comparing the effect of splinting and kinesiotaping in carpal tunnel syndrome on functional status, pain, grip strength, nerve cross-sectional area and sleep quality. Participants were divided into 3 groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Nov 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with mild and moderate carpal tunnel syndrome with nerve conduction velocity study
- To be between the ages of 18-65
Who cannot join
- Inflammatory disease (rheumatoid arthritis, tendinitis, etc.),
- Osteoarthritis in the hand/wrist,
- Musculoskeletal conditions (hand, elbow, wrist),
- Thyroid disease
- Chronic kidney failure
- Carpal tunnel syndrome surgery,
Show all 9Show fewer
- History of surgery and/or trauma to the upper extremity and neck.
- Pregnancy or diabetes-related carpal tunnel syndrome,
- Receiving any treatment for carpal tunnel syndrome (splint therapy, electrophysical agents, exercise, local corticosteroid injection) up to 3 months prior to the tests.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Beyhekim Research and Training Hospital
Konya, Selçuklu, 42060
About this study
Official title: Effect of Splinting and Kinesiotaping Treatments on Functional Status, Sleep Quality and Median Nerve Cross-sectional Area in Carpal Tunnel Syndrome: a Single Blind Prospective Randomized Controlled Study
The effect of conservative treatments on sleep quality in carpal tunnel syndrome is unclear.
Comparing the effect of splinting and kinesiotaping in carpal tunnel syndrome on functional status, pain, grip strength, nerve cross-sectional area and sleep quality.
Participants were divided into 3 groups. One group received night splint and nerve tendon gliding exercises, one group received kinesiotaping and nerve tendon gliding exercises, and one group received only nerve tendon gliding exercises. Participants were evaluated by a blinded investigator at baseline and at 3 months by Visual Analogue Scale (VAS), Boston Carpal Tunnel Syndrome Questionnaire, Pittsburgh Sleep Quality Index (PSQI), Jamar hand dynamometer and ultrasonography.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- splint
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
splintDevice
ready night splints
| Study group | Role | What they receive |
|---|---|---|
| splint and exercise | Experimental | The patient was asked to wear the fabricated splint that fixes the wrist in the neutral position every night and during the day as much as possible Receives: Device: splint |
| kinesiotaping and exercise | Experimental | Kinesiotaping was applied twice a week for a total of 8 sessions for 4 weeks. Taping was performed with a "neural technique" for the median and "field correction technique" for releasing the carpal tunnel. The elbow was positioned in full extension, the forearm in supination, and the wrist in 30 extension. I tape was used for neural technique. Tape was applied to the skin along the median nerve from the second and third metacarpophalangeal joints to five centimetres distal to the medial epicondyle. For the area correction technique, the I tape, which is half of the wrist circumference, was heavily stretched to the volar side of the wrist and the middle 1/3 part was taped without stretching the edges. Receives: Device: splint |
| exercise | Active comparator | Nerve tendon gliding exercises were taught practically by an experienced physiotherapist. Participants were asked to do three sets of 10 repetitions every day for one month. Tendon gliding exercises were performed by bringing the hand into five different positions: regular grip, hook grip, punch, tabletop, and regular punch. Nerve gliding exercises were performed by bringing the fingers and wrist into six different positions: fingers and thumb in flexion with the wrist in neutral position, fingers and thumb in extension with the wrist in neutral position, thumb in neutral position with the wrist and fingers in extension, wrist, fingers, and thumb in extension, forearm in supination, and gentle stretching of the thumb with the other hand. Patients were given a thirty day exercise diary. Receives: Device: splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality
Evaluated with "The Pittsburgh Sleep Quality Index ".
Measured: at baseline and third month
median nerve cross-sectional area
Measured at the wrist by ultrasonography.
Measured: at baseline and third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Nov 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
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 Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514625
- Sponsor's protocol ID
- 79735520-799
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Karpuz S, Yilmaz R, Ozkan M, Kaya IC, Bulut O, Erol K, Yilmaz H. Effect of splinting and kinesiotaping treatments on functional status, sleep quality and median nerve cross-sectional area in carpal tunnel syndrome: A single blind prospective randomized controlled study. J Hand Ther. 2025 Jul-Sep;38(3):483-491. doi: 10.1016/j.jht.2024.12.001. Epub 2025 Jan 6.
PubMed 39765425
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Splinting and Kinesiotaping Treatments on Functional Status, Sleep Quality and Median Nerve Cross-sectional Area in Carpal Tunnel Syndrome: a Single Blind Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06514625
- Acronym / sponsor ID
- 79735520-799
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 23 Jul 2024 (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.
The effect of conservative treatments on sleep quality in carpal tunnel syndrome is unclear.
Comparing the effect of splinting and kinesiotaping in carpal tunnel syndrome on functional status, pain, grip strength, nerve cross-sectional area and sleep quality.
Participants were divided into 3 groups. One group received night splint and nerve tendon gliding exercises, one group received kinesiotaping and nerve tendon gliding exercises, and one group received only nerve tendon gliding exercises. Participants were evaluated by a blinded investigator at baseline and at 3 months by Visual Analogue Scale (VAS), Boston Carpal Tunnel Syndrome Questionnaire, Pittsburgh Sleep Quality Index (PSQI), Jamar hand dynamometer and ultrasonography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| splint and exercise | Experimental | Device: splintThe patient was asked to wear the fabricated splint that fixes the wrist in the neutral position every night and during the day as much as possible |
| kinesiotaping and exercise | Experimental | Device: splintKinesiotaping was applied twice a week for a total of 8 sessions for 4 weeks. Taping was performed with a "neural technique" for the median and "field correction technique" for releasing the carpal tunnel. The elbow was positioned in full extension, the forearm in supination, and the wrist in 30 extension. I tape was used for neural technique. Tape was applied to the skin along the median nerve from the second and third metacarpophalangeal joints to five centimetres distal to the medial epicondyle. For the area correction technique, the I tape, which is half of the wrist circumference, was heavily stretched to the volar side of the wrist and the middle 1/3 part was taped without stretching the edges. |
| exercise | Active comparator | Device: splintNerve tendon gliding exercises were taught practically by an experienced physiotherapist. Participants were asked to do three sets of 10 repetitions every day for one month. Tendon gliding exercises were performed by bringing the hand into five different positions: regular grip, hook grip, punch, tabletop, and regular punch. Nerve gliding exercises were performed by bringing the fingers and wrist into six different positions: fingers and thumb in flexion with the wrist in neutral position, fingers and thumb in extension with the wrist in neutral position, thumb in neutral position with the wrist and fingers in extension, wrist, fingers, and thumb in extension, forearm in supination, and gentle stretching of the thumb with the other hand. Patients were given a thirty day exercise diary. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being diagnosed with mild and moderate carpal tunnel syndrome with nerve conduction velocity study
- To be between the ages of 18-65
Key exclusion criteria (9 listed)
- Inflammatory disease (rheumatoid arthritis, tendinitis, etc.),
- Osteoarthritis in the hand/wrist,
- Musculoskeletal conditions (hand, elbow, wrist),
- Thyroid disease
- Chronic kidney failure
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 |
|---|---|---|
| splintready night splints | Device | exercise, kinesiotaping and exercise, splint and exercise |
Primary outcome
sleep quality
Time frame: at baseline and third month
Evaluated with "The Pittsburgh Sleep Quality Index ".
median nerve cross-sectional area
Time frame: at baseline and third month
Measured at the wrist by ultrasonography.
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 23 Jul 2024.
- Derived from this study: PubMed 39765425Karpuz S, Yilmaz R, Ozkan M, Kaya IC, Bulut O, Erol K, Yilmaz H. Effect of splinting and kinesiotaping treatments on functional status, sleep quality and median nerve cross-sectional area in carpal tunnel syndrome: A single blind prospective randomized controlled study. J Hand Ther. 2025 Jul-Sep;38(3):483-491. doi: 10.1016/j.jht.2024.12.001. Epub 2025 Jan 6.
- Individual participant dataSharing planned: Undecided
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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?
A study testing splint in people with Carpal Tunnel Syndrome, run by Konya Beyhekim Training and Research Hospital 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 2 inclusion and 9 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 23 Jul 2024. 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?
sleep quality (time frame: at baseline and third month). The study lists 2 primary outcomes in all. 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 NCT06514625, 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 23 Jul 2024.