Effects of Two Different Kinesiotaping Techniques in Carpal Tunnel Syndrome

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое Standard Exercise and Splint Therapy
  Twelve weeks of tendon/nerve gliding exercises and night splinting.

Первичные конечные точки

• Median Nerve Flattening Ratio (FR) [Срок оценки: At baseline (T0), 3rd week (T1), and 12th week (T2)]
• Median Nerve Cross-Sectional Area (CSA) [Срок оценки: At baseline (T0), 3rd week (T1), and 12th week (T2)]

Вторичные конечные точки (5)

• Visual Analog Scale (VAS) for Pain (Rest and activity pain intensity, 0-10 cm) [Срок оценки: At baseline (T0), 3rd week (T1), and 12th week (T2)]
• Visual Analog Scale (VAS) for Numbness/Paresthesia (Median nerve trajectory, 0-10 cm) [Срок оценки: At baseline (T0), 3rd week (T1), and 12th week (T2)]
• Boston Carpal Tunnel Questionnaire (BCTQ) for Symptom Severity and Functional Status [Срок оценки: At baseline (T0), 3rd week (T1), and 12th week (T2)]
• Douleur Neuropathique 4 (DN4) Questionnaire Score [Срок оценки: At baseline (T0), 3rd week (T1), and 12th week (T2)]
• Jamar Dynamometer Grip Strength in Kilograms (kg) [Срок оценки: At baseline (T0), 3rd week (T1), and 12th week (T2)]

Критерии участия

Критерии включения

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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07742293 · Protocol ID: 984

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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