Carpal Tunnel SyndromeCTS-TAPENCT07742293
Effects of Two Different Kinesiotaping Techniques in Carpal Tunnel Syndrome
A study testing I-Strip Kinesiotaping and Standard Therapy, Button Hole Kinesiotaping and Standard Therapy and Standard Exercise and Splint Therapy in people with Carpal Tunnel Syndrome, run by Kayseri City Hospital.
Trial summary
This study aims to evaluate the clinical, functional, and ultrasonographic effects of two different kinesiotaping techniques added to a standard exercise and night splint program in the treatment of Carpal Tunnel Syndrome (CTS). 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?
- I-Strip Kinesiotaping and Standard Therapy, Button Hole Kinesiotaping and Standard Therapy and Standard Exercise and Splint Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Mar 2027
- 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
- Being aged between 18 and 65 years.
- Willingness and ability to sign the informed consent form.
- Having symptoms of carpal tunnel syndrome (hand numbness, tingling, pain) for at least 3 months.
- Clinical diagnosis of mild-to-moderate carpal tunnel syndrome confirmed by physical examination (positive Phalen/Tinel tests) and a prior nerve conduction study (EMG).
Who cannot join
- Previous wrist or hand surgery.
- Severe carpal tunnel syndrome on EMG (evidence of thenar atrophy or severe motor loss).
- History of trauma, fracture in the wrist area, or anatomical anomalies affecting ultrasonography.
- Cervical radiculopathy, polyneuropathy, diabetic neuropathy, or other concomitant upper extremity entrapment neuropathies.
- Local corticosteroid injection to the carpal tunnel within the last 6 months.
- Pregnancy.
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- Systemic corticosteroid use or inflammatory rheumatic diseases.
- Cognitive impairment or psychiatric illness preventing comprehension of questionnaire instructions.
- Lack of a prior EMG report upon admission to the outpatient clinic.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Two Different Kinesiotaping Techniques Added to Exercise on Clinical, Functional, and Ultrasonographic Outcomes in Carpal Tunnel Syndrome: A Randomized Controlled, Evaluator-Blinded Study
This study aims to evaluate the clinical, functional, and ultrasonographic effects of two different kinesiotaping techniques added to a standard exercise and night splint program in the treatment of Carpal Tunnel Syndrome (CTS). Participants will be randomly assigned to one of three groups: the I-Strip kinesiotaping technique group, the Button Hole kinesiotaping technique group, or a control group receiving only standard therapy. The study will assess treatment outcomes over a 12-week period using high-resolution ultrasound (specifically median nerve cross-sectional area and flattening ratio) and clinical parameters to determine the most effective conservative management approach.
Read the detailed description
Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy, typically managed conservatively with tendon and nerve gliding exercises alongside night splints. Recently, Kinesiotaping (KT) has gained popularity for its space-correction mechanism, which aims to increase microcirculation and reduce mechanical pressure on the median nerve. While immediate effects of KT have been studied, there is a lack of literature comparing the long-term structural and clinical effects of specific taping methods.
This prospective, randomized controlled, evaluator-blinded trial is designed to compare the 12-week efficacy of the original "I-Strip" and "Button Hole" kinesiotaping techniques when combined with standard exercise and splint therapy, against a standard therapy-only control group.
The primary objective is to investigate morphological changes in the median nerve using high-resolution neurosonography, specifically tracking the Cross-Sectional Area (CSA) and Flattening Ratio (FR) at the carpal tunnel inlet. Secondary objectives include evaluating improvements in pain and upper extremity functionality. By objectively monitoring structural recovery through dynamic ultrasound imaging, this study aims to provide evidence-based recommendations on the long-term anatomical and clinical benefits of different kinesiotaping applications in CTS management.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- I-Strip Kinesiotaping and Standard Therapy, Button Hole Kinesiotaping and Standard Therapy, Standard Exercise and Splint Therapy
- Keywords
- Kinesiotaping, Ultrasonography, Median Nerve, Exercise Therapy
- 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.
I-Strip Kinesiotaping and Standard TherapyOther
Application of the original I-Strip kinesiotaping technique combined with a standard program of tendon/nerve gliding exercises and a night splint for 12 weeks.
Button Hole Kinesiotaping and Standard TherapyOther
Application of the Button Hole kinesiotaping technique combined with a standard program of tendon/nerve gliding exercises and a night splint for 12 weeks.
Standard Exercise and Splint TherapyOther
Twelve weeks of tendon/nerve gliding exercises and night splinting.
| Study group | Role | What they receive |
|---|---|---|
| I-Strip Kinesiotaping Group | Experimental | Participants will receive the original I-Strip kinesiotaping technique combined with standard exercise and a night splint program. Receives: Other: I-Strip Kinesiotaping and Standard Therapy; Other: Standard Exercise and Splint Therapy |
| Button Hole Kinesiotaping Group | Experimental | Participants will receive the Button Hole kinesiotaping technique combined with standard exercise and a night splint program. Receives: Other: Button Hole Kinesiotaping and Standard Therapy; Other: Standard Exercise and Splint Therapy |
| Control Group | Active comparator | Participants will only receive a standard exercise and overnight splint program. Receives: Other: Standard Exercise and Splint Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Nerve Flattening Ratio (FR)
Measurements will be taken at the pisiform bone level using resolution ultrasound.
Measured: At baseline (T0), 3rd week (T1), and 12th week (T2)
Median Nerve Cross-Sectional Area (CSA)
Using high-resolution ultrasound, measurements will be taken in millimeters square (mm2) at the pisiform bone level.
Measured: At baseline (T0), 3rd week (T1), and 12th week (T2)
Secondary outcomes (5)
Visual Analog Scale (VAS) for Pain (Rest and activity pain intensity, 0-10 cm)
Measured on a 0 to 100 mm scale (where 0 indicates no pain and 100 indicates the worst imaginable pain); higher scores indicate a worse outcome.
Measured: At baseline (T0), 3rd week (T1), and 12th week (T2)
Visual Analog Scale (VAS) for Numbness/Paresthesia (Median nerve trajectory, 0-10 cm)
The Visual Analog Scale (VAS) for numbness and paresthesia is a patient-reported outcome measure used to quantify the intensity of sensory disturbances along the median nerve distribution in the hand. Patients indicate the severity of their symptoms by making a mark on a 10 cm horizontal line anchored by "no numbness/paresthesia" (0 cm) and "worst imaginable numbness/paresthesia" (10 cm). The score is determined by measuring the distance in centimeters from the 0 baseline to the patient's mark. Higher scores reflect greater severity of sensory symptoms.
Measured: At baseline (T0), 3rd week (T1), and 12th week (T2)
Boston Carpal Tunnel Questionnaire (BCTQ) for Symptom Severity and Functional Status
Symptom Severity Scale (SSS): Consists of 11 items assessing pain, paresthesia, numbness, weakness, nocturnal symptoms, and overall symptom patterns. Each item is scored from 1 (mildest) to 5 (most severe). The final SSS score is calculated as the mean of the completed items (ranging from 1 to 5).
Functional Status Scale (FSS): Consists of 8 items evaluating the difficulty experienced in performing common daily activities requiring hand function (e.g., writing, buttoning clothes, holding a book, gripping objects). Each item is scored from 1 to 5. The final FSS score is calculated as the mean of the items (ranging from 1 to 5).
For both subscales, higher scores indicate worse symptom severity and greater functional impairment.
Measured: At baseline (T0), 3rd week (T1), and 12th week (T2)
Douleur Neuropathique 4 (DN4) Questionnaire Score
Scale from 0 to 10; higher scores indicate a greater likelihood of neuropathic pain.
Measured: At baseline (T0), 3rd week (T1), and 12th week (T2)
Jamar Dynamometer Grip Strength in Kilograms (kg)
The average of three consecutive measurements taken in kilograms (kg) using a Jamar dynamometer; higher values indicate better grip strength.
Measured: At baseline (T0), 3rd week (T1), and 12th week (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Furkan Erdinc, MD, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742293
- Sponsor's protocol ID
- Protocol ID: 984
- Acronym
- CTS-TAPE
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data underlying the results reported in the published article will be shared upon reasonable request directed to the corresponding author, starting from publication and ending 3 years following article publication.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Kinesiotaping Techniques Added to Exercise on Clinical, Functional, and Ultrasonographic Outcomes in Carpal Tunnel Syndrome: A Randomized Controlled, Evaluator-Blinded Study
- ClinicalTrials.gov ID
- NCT07742293
- Acronym / sponsor ID
- CTS-TAPE / Protocol ID: 984
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Kinesiotaping, Ultrasonography, Median Nerve, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Aug 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.
This study aims to evaluate the clinical, functional, and ultrasonographic effects of two different kinesiotaping techniques added to a standard exercise and night splint program in the treatment of Carpal Tunnel Syndrome (CTS). Participants will be randomly assigned to one of three groups: the I-Strip kinesiotaping technique group, the Button Hole kinesiotaping technique group, or a control group receiving only standard therapy. The study will assess treatment outcomes over a 12-week period using high-resolution ultrasound (specifically median nerve cross-sectional area and flattening ratio) and clinical parameters to determine the most effective conservative management approach.
Detailed description
Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy, typically managed conservatively with tendon and nerve gliding exercises alongside night splints. Recently, Kinesiotaping (KT) has gained popularity for its space-correction mechanism, which aims to increase microcirculation and reduce mechanical pressure on the median nerve. While immediate effects of KT have been studied, there is a lack of literature comparing the long-term structural and clinical effects of specific taping methods.
This prospective, randomized controlled, evaluator-blinded trial is designed to compare the 12-week efficacy of the original "I-Strip" and "Button Hole" kinesiotaping techniques when combined with standard exercise and splint therapy, against a standard therapy-only control group.
The primary objective is to investigate morphological changes in the median nerve using high-resolution neurosonography, specifically tracking the Cross-Sectional Area (CSA) and Flattening Ratio (FR) at the carpal tunnel inlet. Secondary objectives include evaluating improvements in pain and upper extremity functionality. By objectively monitoring structural recovery through dynamic ultrasound imaging, this study aims to provide evidence-based recommendations on the long-term anatomical and clinical benefits of different kinesiotaping applications in CTS management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I-Strip Kinesiotaping Group | Experimental | Other: I-Strip Kinesiotaping and Standard Therapy, Other: Standard Exercise and Splint TherapyParticipants will receive the original I-Strip kinesiotaping technique combined with standard exercise and a night splint program. |
| Button Hole Kinesiotaping Group | Experimental | Other: Button Hole Kinesiotaping and Standard Therapy, Other: Standard Exercise and Splint TherapyParticipants will receive the Button Hole kinesiotaping technique combined with standard exercise and a night splint program. |
| Control Group | Active comparator | Other: Standard Exercise and Splint TherapyParticipants will only receive a standard exercise and overnight splint program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being aged between 18 and 65 years.
- Willingness and ability to sign the informed consent form.
- Having symptoms of carpal tunnel syndrome (hand numbness, tingling, pain) for at least 3 months.
- Clinical diagnosis of mild-to-moderate carpal tunnel syndrome confirmed by physical examination (positive Phalen/Tinel tests) and a prior nerve conduction study (EMG).
Key exclusion criteria (9 listed)
- Previous wrist or hand surgery.
- Severe carpal tunnel syndrome on EMG (evidence of thenar atrophy or severe motor loss).
- History of trauma, fracture in the wrist area, or anatomical anomalies affecting ultrasonography.
- Cervical radiculopathy, polyneuropathy, diabetic neuropathy, or other concomitant upper extremity entrapment neuropathies.
- Local corticosteroid injection to the carpal tunnel within 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 |
|---|---|---|
| I-Strip Kinesiotaping and Standard TherapyApplication of the original I-Strip kinesiotaping technique combined with a standard program of tendon/nerve gliding exercises and a night splint for 12 weeks. | Other | I-Strip Kinesiotaping Group |
| Button Hole Kinesiotaping and Standard TherapyApplication of the Button Hole kinesiotaping technique combined with a standard program of tendon/nerve gliding exercises and a night splint for 12 weeks. | Other | Button Hole Kinesiotaping Group |
| Standard Exercise and Splint TherapyTwelve weeks of tendon/nerve gliding exercises and night splinting. | Other | Button Hole Kinesiotaping Group, Control Group, I-Strip Kinesiotaping Group |
Primary outcome
Median Nerve Flattening Ratio (FR)
Time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)
Measurements will be taken at the pisiform bone level using resolution ultrasound.
Median Nerve Cross-Sectional Area (CSA)
Time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)
Using high-resolution ultrasound, measurements will be taken in millimeters square (mm2) at the pisiform bone level.
5 secondary outcomes
Visual Analog Scale (VAS) for Pain (Rest and activity pain intensity, 0-10 cm)
Time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)
Visual Analog Scale (VAS) for Numbness/Paresthesia (Median nerve trajectory, 0-10 cm)
Time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)
Boston Carpal Tunnel Questionnaire (BCTQ) for Symptom Severity and Functional Status
Time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)
Douleur Neuropathique 4 (DN4) Questionnaire Score
Time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)
Jamar Dynamometer Grip Strength in Kilograms (kg)
Time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)
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 7 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data underlying the results reported in the published article will be shared upon reasonable request directed to the corresponding author, starting from publication and ending 3 years following article publication.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing I-Strip Kinesiotaping and Standard Therapy, Button Hole Kinesiotaping and Standard Therapy and Standard Exercise and Splint Therapy in people with Carpal Tunnel Syndrome, run by Kayseri City Hospital.
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 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: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Furkan Erdinc, MD (+905413216609, frkn.erdinc01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Nerve Flattening Ratio (FR) (time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)). 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?
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 7 Aug 2026.