Carpal Tunnel Syndrome (CTS)NCT07458152
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
A study testing Flexion Splint, Neutral Splint and Extension Splint in people with Carpal Tunnel Syndrome (CTS) and Peripheral Neuropathies, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Carpal tunnel syndrome (CTS) is the most common nerve compression syndrome. It develops as a result of the compression of the median nerve while passing through the osteofibrous structure of the carpal tunnel located at the wrist. Sensory symptoms are the most prominent feature of CTS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies, Median Nerve Entrapment
- What is being tested?
- Flexion Splint, Neutral Splint and Extension Splint
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of mild to moderate carpal tunnel syndrome confirmed by electrophysiological studies performed within the last year.
- Clinical findings consistent with carpal tunnel syndrome.
- Age between 18 and 65 years.
Who cannot join
- <18 years or >65 years
- Thenar atrophy
- Surgery history for CTS
- Steroid injection for CTS
- Physical treatment for CTS in the last 6 months
- Cervical radiculopathy
Show all 14Show fewer
- Tenosynovitis
- Peripheral polyneuropathy
- Another compressive neuropathy in the ipsilateral upper extremity
- History of trauma/fracture to the hand-wrist region
- Pregnancy
- Metabolic disease
- Rheumatic/autoimmune disease
- Kidney failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University
Istanbul
Fatma Merih Akpınar, +90 2124142000, merihcaliskan@gmail.com
About this study
Official title: Evaluation of the Effectiveness of Splint Use in Different Wrist Positions in the Treatment of Carpal Tunnel Syndrome: A Single-Blind, Randomized, Controlled Trial
Carpal tunnel syndrome (CTS) is the most common nerve compression syndrome. It develops as a result of the compression of the median nerve while passing through the osteofibrous structure of the carpal tunnel located at the wrist. Sensory symptoms are the most prominent feature of CTS. These symptoms are observed as pain, paresthesia, and decreased sensory sensitivity. As motor symptoms, thumb abduction and opposition are primarily affected. In advanced cases, atrophy develops in the thenar muscles. Patients may describe weakness as difficulty in writing, opening jars, buttoning, or grasping objects. The diagnosis is made by fulfilling both clinical and electrophysiological diagnostic criteria. CTS has both conservative and surgical treatment options. Conservative treatment includes splinting, physical therapy modalities, and injection options, and it is preferred in mild and moderate cases. Among non-surgical treatment options, splint use is a commonly applied intervention; however, there is no consensus regarding its effectiveness, the optimal wrist position during use, or the duration and frequency of splint application. A total of 108 hands from patients aged 18 to 55 years diagnosed with CTS will be included in this study and randomized into three groups. All groups will be given an education and exercise program. The first group will use a wrist splint fixed at 15° flexion; the second group at neutral position; and the third group at 20° extension, to be worn only at night for eight weeks. Patients will be evaluated before treatment, immediately after treatment, and two months after the end of treatment using measures of pain- numbness severity, functional status, motor and sensory examination findings, and nerve conduction studies. What makes this study unique is that it evaluates the effects of splints that stabilize the wrist at different angles together with electrophysiological findings. A review of the literature shows that while some studies have examined and compared the effects of splints fixed at different wrist angles on symptoms, functional status, and physical examination findings, there is no study that evaluates these effects along with electrophysiological findings. Therefore, this study, which will compare the effectiveness of splints at different angles, is expected to contribute to the literature. The expected outcomes of this research are that one or more types of splints used in the conservative treatment of CTS will provide improvements in symptom severity, functional status, sensory and motor physical examination findings, and electrophysiological evaluation findings at the end of treatment.
- Being tested
- Flexion Splint, Neutral Splint, Extension Splint, Education, Exercise
- Keywords
- Splints, Electromyography, Wrist splinting, Rehabilitation, Wrist posture
- Medical subject headings
- Carpal Tunnel Syndrome, Peripheral Nervous System Diseases, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexion SplintOther
Participants will wear wrist splint fixed at 15° of wrist flexion during nighttime only for eight weeks.
Neutral SplintOther
Participants will wear a wrist splint maintaining the wrist in a neutral position during nighttime only for eight weeks.
Extension SplintOther
Participants will wear a wrist splint fixed at 20° of wrist extension during nighttime only for eight weeks.
EducationBehavioural
All participants will also receive a standardized education.
ExerciseOther
All participants will also receive a standardized exercise program.
| Study group | Role | What they receive |
|---|---|---|
| 15° Flexion Wrist Splint Group | Active comparator | Not described Receives: Other: Flexion Splint; Behavioral: Education; Other: Exercise |
| Neutral Wrist Splint Group | Active comparator | Not described Receives: Other: Neutral Splint; Behavioral: Education; Other: Exercise |
| 20° Extension Wrist Splint Group | Active comparator | Not described Receives: Other: Extension Splint; Behavioral: Education; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve Conduction Study (NCS)
Median motor distal latency and conduction velocity and second finger recorded median sensory distal latency and conduction velocity will be measured in all individuals. In addition to routine conduction examinations, fourth finger recorded median-ulnar peak latency comparison examinations will also be made.
Measured: Baseline and week 12 (follow-up)
Secondary outcomes (8)
Visual Pain Scale (VAS)
Pain and numbness at rest, at night, and during movement will be assessed using a visual analog scale (VAS) ranging from 0 to 10, where 0 represents "no pain" and 10 represents "unbearable pain."
Measured: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
BCTSQ assesses the severity of symptoms and functional status in patients with carpal tunnel syndrome. The symptom severity scale assesses the symptoms with respect to severity, frequency, time and type. The scale consists of 11 questions with multiple-choice responses, scored from 1 point (mildest) to 5 points (most severe). The overall symptom severity score is calculated as the mean of the scores for the eleven individual items. The functional status scale assesses the affect of the carpal tunnel syndrome on daily living. The scale consists of 8 questions with multiple choice responses, scored from 1 point (no difficulty with the activity) to 5 points (can not perform the activity at all). The overall score for functional status was calculated as the mean of all eight. Thus, a higher symptom severity or functional status score indicates worse symptoms or dysfunction.
Measured: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Semmes Weinstein Monofilament Test (SWMT)
Using 20 pieces of SWMT, sensitive touch threshold sensitivity of each hand will be tested. The examiner and the subject will seated opposite each other. Both arms of the subject will arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. The monofilaments will be touched fingertips of first three fingers on the radial side of both hands, with enough force to bend the monofilament for 1.5 seconds. The thinnest monofilament numbers that the patient feels being touched will be recorded.
Measured: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Two Point Discrimination Test (TPDT)
Two point discrimination sense will be evaluated statically using an esthesiometer. The examiner and the subject will seated opposite each other. Both arms of the subject will arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. The contact time of the discriminator with the fingertip ranged from 3 to 5 seconds. The evaluation will be started by touching a single point on the first three fingertips on the radial side of both hands. Each three fingers will be evaluated separately and the distance between the two touched points will be increased by 1mm in each measurement. The smallest values will be taken in millimeters which the patient feels the two points as two separate points on the tested hand will be noted and the the average value written as the result.
Measured: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Hand Grip Force
The squeeze force will be measured while the patients are sitting, with the elbow in 90 degrees flexion and they will be asked to make a maximally voluntary grip. Measurements will be made three times in a row on both hands and the average of the three measurements will be noted as a result in kilogram (kg).
Measured: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Thumb and Forefinger Pinch Force
The pinch force with thumb and forefinger will be measured while the patients are sitting, with the elbow in 90 degrees flexion and they will be asked to make a maximally voluntary grip.The pinch force will be measured as kg with a pinch dynamometer, and the average of the three measurements will be noted as a result.
Measured: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Manuel Muscle Testing of M. Abductor Pollicis Brevis
Manual muscle testing will be evaluated in 5 grades. No visible or palpable muscle contraction 0, visible or palpable muscle contraction without motion grade 1, muscle contraction that creates movement at full of range of motion when gravity is eliminated grade 2, muscle contraction that creates movement at full of range of motion against gravity grade 3, muscle contraction that creates movement at full of range of motion against gravity and moderate resistance grade 4, muscle contraction that creates movement through the entire range of motion of the joint against gravity and full resistance will be considered as the grade 5
Measured: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Vibration Sensation
Vibration sense was tested with tuning fork. The examiner and the subject will be seated opposite each other. Both arms of the subject will be arranged on a table in supination, with palm upwards. The patient will be instructed to close their eyes. Vibrating tuning fork will be placed on the palmar aspect of the distal phalanx of first three fingers on the radial side of both hands, The patient will be asked to say 'done' when the vibration in his hand was over. The average of three measurements will be noted as a result in seconds.
Measured: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Mar 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- More trials run by Istanbul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Merih Akpınar, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458152
- Sponsor's protocol ID
- E-29624016-050.99-3310018
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Splint Use in Different Wrist Positions in the Treatment of Carpal Tunnel Syndrome: A Single-Blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07458152
- Acronym / sponsor ID
- E-29624016-050.99-3310018
- Keywords
- Splints, Electromyography, Wrist splinting, Rehabilitation, Wrist posture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 9 Mar 2026 (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.
Carpal tunnel syndrome (CTS) is the most common nerve compression syndrome. It develops as a result of the compression of the median nerve while passing through the osteofibrous structure of the carpal tunnel located at the wrist. Sensory symptoms are the most prominent feature of CTS. These symptoms are observed as pain, paresthesia, and decreased sensory sensitivity. As motor symptoms, thumb abduction and opposition are primarily affected. In advanced cases, atrophy develops in the thenar muscles. Patients may describe weakness as difficulty in writing, opening jars, buttoning, or grasping objects. The diagnosis is made by fulfilling both clinical and electrophysiological diagnostic criteria. CTS has both conservative and surgical treatment options. Conservative treatment includes splinting, physical therapy modalities, and injection options, and it is preferred in mild and moderate cases. Among non-surgical treatment options, splint use is a commonly applied intervention; however, there is no consensus regarding its effectiveness, the optimal wrist position during use, or the duration and frequency of splint application. A total of 108 hands from patients aged 18 to 55 years diagnosed with CTS will be included in this study and randomized into three groups. All groups will be given an education and exercise program. The first group will use a wrist splint fixed at 15° flexion; the second group at neutral position; and the third group at 20° extension, to be worn only at night for eight weeks. Patients will be evaluated before treatment, immediately after treatment, and two months after the end of treatment using measures of pain- numbness severity, functional status, motor and sensory examination findings, and nerve conduction studies. What makes this study unique is that it evaluates the effects of splints that stabilize the wrist at different angles together with electrophysiological findings. A review of the literature shows that while some studies have examined and compared the effects of splints fixed at different wrist angles on symptoms, functional status, and physical examination findings, there is no study that evaluates these effects along with electrophysiological findings. Therefore, this study, which will compare the effectiveness of splints at different angles, is expected to contribute to the literature. The expected outcomes of this research are that one or more types of splints used in the conservative treatment of CTS will provide improvements in symptom severity, functional status, sensory and motor physical examination findings, and electrophysiological evaluation findings at the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15° Flexion Wrist Splint Group | Active comparator | Other: Flexion Splint, Behavioral: Education, Other: Exercise |
| Neutral Wrist Splint Group | Active comparator | Other: Neutral Splint, Behavioral: Education, Other: Exercise |
| 20° Extension Wrist Splint Group | Active comparator | Other: Extension Splint, Behavioral: Education, Other: Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of mild to moderate carpal tunnel syndrome confirmed by electrophysiological studies performed within the last year.
- Clinical findings consistent with carpal tunnel syndrome.
- Age between 18 and 65 years.
Key exclusion criteria (14 listed)
- <18 years or >65 years
- Thenar atrophy
- Surgery history for CTS
- Steroid injection for CTS
- Physical treatment for CTS 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 |
|---|---|---|
| Flexion SplintParticipants will wear wrist splint fixed at 15° of wrist flexion during nighttime only for eight weeks. | Other | 15° Flexion Wrist Splint Group |
| Neutral SplintParticipants will wear a wrist splint maintaining the wrist in a neutral position during nighttime only for eight weeks. | Other | Neutral Wrist Splint Group |
| Extension SplintParticipants will wear a wrist splint fixed at 20° of wrist extension during nighttime only for eight weeks. | Other | 20° Extension Wrist Splint Group |
| EducationAll participants will also receive a standardized education. | Behavioural | 15° Flexion Wrist Splint Group, 20° Extension Wrist Splint Group, Neutral Wrist Splint Group |
| ExerciseAll participants will also receive a standardized exercise program. | Other | 15° Flexion Wrist Splint Group, 20° Extension Wrist Splint Group, Neutral Wrist Splint Group |
Primary outcome
Nerve Conduction Study (NCS)
Time frame: Baseline and week 12 (follow-up)
Median motor distal latency and conduction velocity and second finger recorded median sensory distal latency and conduction velocity will be measured in all individuals. In addition to routine conduction examinations, fourth finger recorded median-ulnar peak latency comparison examinations will also be made.
8 secondary outcomes
Visual Pain Scale (VAS)
Time frame: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
Time frame: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Semmes Weinstein Monofilament Test (SWMT)
Time frame: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Two Point Discrimination Test (TPDT)
Time frame: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Hand Grip Force
Time frame: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Thumb and Forefinger Pinch Force
Time frame: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Manuel Muscle Testing of M. Abductor Pollicis Brevis
Time frame: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Vibration Sensation
Time frame: Baseline, Week 8 (end of intervention) and Week 12 (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexion Splint, Neutral Splint and Extension Splint in people with Carpal Tunnel Syndrome (CTS) and Peripheral Neuropathies, run by Istanbul 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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve Conduction Study (NCS) (time frame: Baseline and week 12 (follow-up)). 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 4 Nov 2026.