Carpal Tunnel Syndrome
Conditions
Keywords
Kinesiotaping, Ultrasonography, Median Nerve, Exercise Therapy
Brief 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). 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.
Interventions
OTHERButton Hole Kinesiotaping and Standard Therapy
Application of the Button Hole kinesiotaping technique combined with a standard program of tendon/nerve gliding exercises and a night splint for 12 weeks.
OTHERStandard Exercise and Splint Therapy
Twelve weeks of tendon/nerve gliding exercises and night splinting.
OTHERI-Strip Kinesiotaping and Standard 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.
Sponsors
Kayseri City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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).
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Nerve Flattening Ratio (FR) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Pain (Rest and activity pain intensity, 0-10 cm) | At baseline (T0), 3rd week (T1), and 12th week (T2) | 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. |
| Visual Analog Scale (VAS) for Numbness/Paresthesia (Median nerve trajectory, 0-10 cm) | At baseline (T0), 3rd week (T1), and 12th week (T2) | 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. |
| Boston Carpal Tunnel Questionnaire (BCTQ) for Symptom Severity and Functional Status | At baseline (T0), 3rd week (T1), and 12th week (T2) | 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. |
| Douleur Neuropathique 4 (DN4) Questionnaire Score | At baseline (T0), 3rd week (T1), and 12th week (T2) | Scale from 0 to 10; higher scores indicate a greater likelihood of neuropathic pain. |
| Jamar Dynamometer Grip Strength in Kilograms (kg) | At baseline (T0), 3rd week (T1), and 12th week (T2) | The average of three consecutive measurements taken in kilograms (kg) using a Jamar dynamometer; higher values indicate better grip strength. |
Contacts
CONTACTFurkan Erdinc, MD
Outcome results
None listed