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Not yet recruiting NCT07742293

Effects of Two Different Kinesiotaping Techniques in Carpal Tunnel Syndrome

No phase Interventional Carpal Tunnel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: I-Strip Kinesiotaping and Standard Therapy, Button Hole Kinesiotaping and Standard Therapy, Standard Exercise and Splint Therapy.
Who it may be relevant to
Registry conditions: Carpal Tunnel Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

  • Other I-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.
  • Other Button 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.
  • Other Standard Exercise and Splint Therapy
    Twelve weeks of tendon/nerve gliding exercises and night splinting.

Primary outcome measures

  • Median Nerve Flattening Ratio (FR) [Time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)]
  • Median Nerve Cross-Sectional Area (CSA) [Time frame: At baseline (T0), 3rd week (T1), and 12th week (T2)]
Secondary outcome measures (5)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07742293 · Protocol ID: 984

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗