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NCT Number: NCT06981715

Investigation of the Efficacy of Extracorporeal Shock Wave Therapy and Kinesiotaping Applied as an Addition to Conservative Treatment in Individuals With Carpal Tunnel Syndrome

This study was conducted to compare the effectiveness of different treatment combinations in individuals with carpal tunnel syndrome (CTS). Participants were divided into three groups: The control group received only night splinting and exercise programme, while the second group received extracorporeal shock wave therapy (ESWT) in addition. The third group received kinesiobanding in addition to night splinting, exercise and ESWT. The study evaluates the effect of multimodal conservative treatment approaches on CTS symptoms and aims to demonstrate the additional benefits of ESWT and kinesiobanding in particular. The findings provide important clues for clinical practice.

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

About this study

Carpal tunnel syndrome (CTS) is a common entrapment neuropathy resulting from compression of the median nerve at the wrist level, with symptoms such as paresthesia, pain and loss of muscle strength. This study comparatively evaluated the effects of different conservative treatment combinations on symptoms and functional status in individuals with CTS. Participants were divided into three groups. The control group received the standard conservative approach of night splinting and exercise programme. Extracorporeal shock wave therapy (ESWT) group received ESWT, which is known to increase tissue regeneration and blood flow, in addition to night splinting and exercise. In the ESWT+Taping group, in addition to night splinting, exercise and ESWT, kinesiobanding, which aims to provide proprioceptive support and reduce oedema, was applied. Pain intensity, symptom severity, functionality, hand grip strength and electrophysiological parameters were evaluated before and after treatment. This study draws attention to the importance of multidisciplinary and holistic approaches in the treatment of CTS and offers important contributions to clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients between the ages of 18 and 65 who applied to Ahi Evran University Physical Medicine and Rehabilitation Outpatient Clinic and were diagnosed with moderate or mild carpal tunnel syndrome by clinical, physical examination and EMG
  • Patients who understand and can apply the patient information form
  • Patients who gave consent and participated in the study according to the informed consent form

Exclusion criteria

  • Cervical radiculopathy
  • Polyneuropathy
  • Brachial plexopathy
  • History of trauma or fracture of the wrist and forearm
  • Systemic corticosteroid use, history of malignancy
  • History of carpal tunnel syndrome surgery
  • Pregnant and lactating women
  • Severe carpal tunnel syndrome, tenar atrophy on physical examination 9.
  • Patient reluctance to participate in treatment

Treatment and study plan

Conservative treatment

Other

Night Splint Resting splint fixing the ankle in neutral position

Worn every night before going to bed, used for 6-8 hours

Objective: To reduce the pressure on the median nerve

Exercise Programme:

Applied 1-2 times a day

Each exercise 10 repetitions, 2 sets

Content:

Nerve mobilisation exercises (median nerve sliding and stretching)

Wrist stretching and flexor-extensor tendon sliding exercises

Finger opening-closing, fist making exercises

ESWT

Other

ESWT Protocol:

Device Radial ESWT device Area of application Wrist volar surface (carpal tunnel area) Parameters Frequency: 5 Hz 4 Bar Number of beats 2000 pulses/session Application time 5-10 minutes per session

Kinesiotaping

Other

Kinesio taping was performed with the Button hole technique described by Dr Kenzo Kase. In this technique, a kinesio tape was measured and cut from the medial and lateral epicondyle level on the palmar side of the forearm, from the base of the proximal phalanges to the epicondyles of the humerus on the dorsal side of the forearm. The tape was folded and the midpoint was found, 2 short incisions were made and 2 button holes were obtained through which the 3rd and 4th finger would pass. The paper behind the band was torn and the 3rd and 4th fingers were passed through the holes. The patient's wrist was brought to extension and radial deviation and the tape was glued with a slight (15-25%) tension towards the medial epicondyle on the palmar side of the forearm. Then the wrist was flexed and ulnar deviated and the tape was glued with a slight (15-25%) tension towards the lateral epicondyle.

Primary outcomes

  1. Pain Severity

    Time frame: 5 week

    Visual Analogue Scale (VAS) was used to determine the presence and severity of low back pain in the study participants. GAS is a practical test with high validity and reliability in pain assessment. GAS is an assessment method numbered from 0 to 10, where '0' indicates no pain and '10' indicates the presence of the most severe pain. Participants were asked to mark the degree of pain they had on this scale and recorded.

Secondary outcomes

  1. Symptom Severity and Functionality

    Time frame: 5 week

    It was developed by Levine et al. in 1993 (102). In 2006, its Turkish validity and reliability was performed by Sezgin et al. This scale used for clinical standardisation of CTS consists of nineteen questions. The answers vary between one and five points. A high mean score indicates that the patient has low functional capacity and severe symptoms. The questionnaire consists of two parts, the Boston Symptom Severity Scale (SSS) and the Boston Functional Status Scale (FSS). The Boston-SSS has 11 questions and responses range from 'none (1 point)' to 'very severe (5 points)'. The Boston-FDS has 8 questions and the answers range from 'very easy (1 point)' to 'very difficult (5 points)'. The patient's score is divided by the total score and a ratio between 0 and 1 is obtained. A ratio closer to 1 indicates an increase in dysfunction and symptom severity.

  2. Hand Grip Strength

    Time frame: 5 week

    The Jamar dynamometer was used to measure gross grip strength. Jamar dynamometer measures static grip strength in kilograms. The measurements were performed in the position recommended by the American Society of Hand Therapists, with the patient sitting, arm in adduction, elbow flexed 90 degrees, forearm in neutral position. Patients were asked to squeeze the dynamometer with maximum strength for at least 3 seconds. 3 measurements were made and the measurements were made at 1 minute intervals and the mean was recorded in kilograms.

  3. Electrophysiological Assessments

    Time frame: 5 week

    A Nihon Kohden Neuropack S1 MEB-9400 electroneuromyography (ENMG) device (Nihon Kohden Corp., Tokyo, Japan) was utilized. Values of median sensory distal latency (mSDL) <3.6 ms, and median sensory nerve conduction velocity (mSNCV) >50 m/s were deemed normal. The classification for CTS provided by the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) was utilized.

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 21, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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