An interventional study of I-Strip Kinesiotaping and Standard Therapy and Button Hole Kinesiotaping and Standard Therapy in Carpal Tunnel Syndrome, sponsored by Kayseri City Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Kayseri City Hospital · Not applicable, Interventional, and Treatment
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.
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.
587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Kayseri City Hospital is the lead sponsor of 49 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Being aged between 18 and 65 years.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the original I-Strip kinesiotaping technique combined with standard exercise and a night splint program.
Other: I-Strip Kinesiotaping and Standard Therapy · Other: Standard Exercise and Splint Therapy
Participants will receive the Button Hole kinesiotaping technique combined with standard exercise and a night splint program.
Other: Button Hole Kinesiotaping and Standard Therapy · Other: Standard Exercise and Splint Therapy
Participants will only receive a standard exercise and overnight splint program.
Other: Standard Exercise and Splint Therapy
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.
Application of the Button Hole kinesiotaping technique combined with a standard program of tendon/nerve gliding exercises and a night splint for 12 weeks.
Twelve weeks of tendon/nerve gliding exercises and night splinting.
Median Nerve Flattening Ratio (FR)
Measurements will be taken at the pisiform bone level using resolution ultrasound.
Time frame: 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.
Time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)
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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning from the date of publication and extending for 3 years.
Access criteria: Researchers who provide a scientifically sound proposal and whose proposed use of data has been approved by the principal investigator. Requests can be directed to the corresponding author via email.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Feb 2027, 6 months later.
Of 251 non-industry interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 27. This study's planned 6 months is below that.
Counting every sponsor, half of 261 studies reached it within 12 months; a quarter within 7 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Kayseri City Hospital