Clinical trial NCT06850779: Effects of Radial Extracorporeal Shock Wave and Kinesio Taping Treatments in Patients With Carpal Tunnel Syndrome
Official title: Effects of Radial Extracorporeal Shock Wave and Kinesio Taping Treatments on Quality of Life, Hand Function and Median Nerve Cross-Sectional Area Measured by Ultrasonography in Patients With Carpal Tunnel Syndrome: A Single-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: carpal tunnel syndrome
extracorporeal shock wave therapy
kinesio taping
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carpal Tunnel Syndrome (CTS) is a common upper extremity nerve compression syndrome that causes significant economic and social burden to affected individuals. Although the severity may vary among patients, symptoms such as night pain, transient numbness, tingling, constant pain, muscle weakness, and sleep disturbance may be observed. The treatment of CTS can be grouped as nonsurgical and surgical treatments. The aim of this study is to investigate the effects of treatment with sound waves and a healing method called extracorporeal shock wave therapy and a therapeutic flexible tape called kinesiology taping on pain, grip strength, quality of life, depression symptoms, hand functions, and ultrasonographic median nerve cross-sectional area in patients with CTS.

Detailed description: Carpal tunnel syndrome is the most common nerve entrapment syndrome, typically affecting the dominant extremity. Symptoms often become more pronounced at night, and may include numbness, tingling, electric shock sensations, pain, and other related symptoms. Diagnosis can be made based on patient history, physical examination, electrodiagnostic tests, and ultrasonography. Treatment options include splinting, exercise therapy, physical therapy modalities, various injections, and surgical methods.

In our study, we compared the effects of extracorporeal shock wave therapy (ESWT) and kinesiology taping (KT) on carpal tunnel syndrome. The study involved four randomized groups: Group 1 received both ESWT and KT, Group 2 received only ESWT, Group 3 received only KT, and Group 4 received exercise therapy alone. Evaluations were conducted using the Visual Analog Scale, Boston Carpal Tunnel Questionnaire, Douleur Neuropathique 4 Questions, Nottingham Health Profile, grip strength measurements, and median nerve cross-sectional area via ultrasonography. Evaluations were performed three times: before treatment, at week 3, and at week 6.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate unilateral carpal tunnel syndrome confirmed by electroneuromyography (ENMG)
* Patients over 18 years of age
* Symptom duration of at least 3 months
* Those who have not received any medical treatment other than analgesics in the last 3 months

Exclusion Criteria:

* Bilateral Carpal Tunnel Syndrome (CTS)
* Severe CTS detected by ENMG
* Operated CTS
* Corticosteroid injection within the last 3 months
* History of peripheral nerve damage
* Secondary CTS causes (thyroid dysfunction, connective tissue diseases)
* Cervical disc herniation
* DeQuervain tenosynovitis, trigger finger, Dupuytren contracture
* Inflammatory disorder
* Bleeding disorder
* Pregnancy
* Malignancy

Primary outcomes:
measure: Pain level before treatment, 3rd week and 6th week after treatment
timeFrame: From enrollment to the end of treatment at 3rd week and 6th week
measure: Assessment of symptom severity and functionality
timeFrame: From enrollment to the end of treatment at 3rd week and 6th week
measure: Assessment of median nerve cross sectional area by ultrasonography
timeFrame: From enrollment to the end of treatment at 3rd week and 6th week
Secondary outcomes:
measure: Assessment of grip strength and lateral pinch strength
timeFrame: From enrollment to the end of treatment at 3rd week and 6th week
measure: Assessment of functionality
timeFrame: From enrollment to the end of treatment at 3rd week and 6th week
measure: Assessment of neuropathic pain
timeFrame: From enrollment to the end of treatment at 3rd week and 6th week
measure: Assessment of quality of life
timeFrame: From enrollment to the end of treatment at 3rd week and 6th week
measure: Assessment of depression
timeFrame: From enrollment to the end of treatment at 3rd week and 6th week
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Şişli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: Şişli Hamidiye Etfal Training and Research Hospital, Deparment of Physical Medicine and Rehabilitation
name: Banu Kuran, Professor, MD
role: STUDY_DIRECTOR
References: