Effects of Radial Extracorporeal Shock Wave and Kinesio Taping Treatments in Patients with Carpal Tunnel Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome (CTS)
• Intervention / Treatment: Other: Extracorporeal shock wave therapy (ESWT); Other: Kinesio taping (KT); Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • Sisli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Those who received both extracorporeal shock wave therapy (ESWT) and kinesio taping (KB)	Other: Extracorporeal shock wave therapy (ESWT); Radial ESWT (Vibrolith OrthoⓇ) was applied to the wrist as 1000 pulses with a frequency of 5 Hz and a power of 1.5 bar. The treatment was applied once a week for a total of 3 sessions.; Other: Kinesio taping (KT); KT was prepared as 2 pieces of 2.5 cm I band and 1 piece of 5 cm I band. It was applied with a maximum of 50% tension (without tension on the ends) while the wrist was in 30 degrees of extension, forearm supination and elbow extension. The treatment was applied once a week for a total of 3 sessions.; Other: Exercise; Median nerve gliding exercises were given to the 4th group during the follow-up period. The same exercises were given to the other groups.
Active Comparator: Group 2; Those who received ESWT	Other: Extracorporeal shock wave therapy (ESWT); Radial ESWT (Vibrolith OrthoⓇ) was applied to the wrist as 1000 pulses with a frequency of 5 Hz and a power of 1.5 bar. The treatment was applied once a week for a total of 3 sessions.; Other: Exercise; Median nerve gliding exercises were given to the 4th group during the follow-up period. The same exercises were given to the other groups.
Active Comparator: Group 3; Those who received KT	Other: Kinesio taping (KT); KT was prepared as 2 pieces of 2.5 cm I band and 1 piece of 5 cm I band. It was applied with a maximum of 50% tension (without tension on the ends) while the wrist was in 30 degrees of extension, forearm supination and elbow extension. The treatment was applied once a week for a total of 3 sessions.; Other: Exercise; Median nerve gliding exercises were given to the 4th group during the follow-up period. The same exercises were given to the other groups.
Other: Group 4; Those who received only exercise	Other: Exercise; Median nerve gliding exercises were given to the 4th group during the follow-up period. The same exercises were given to the other groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level before treatment, 3rd week and 6th week after treatment	Pain level will be evaluated with the Visual Analog Scale. (minimum: 0, maximum: 100 mm)	From enrollment to the end of treatment at 3rd week and 6th week
Assessment of symptom severity and functionality	The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) questionnaire was used to assess symptom severity and functionality. It includes 2 subgroups: Symptom Severity Scale (SSS) and Functional Status Scale (FSS). Symptom severity is assessed with 11 questions, and functional status is assessed with 8 questions. Each question is scored from low to high, 1 to 5. As the total score increases, deterioration increases.	From enrollment to the end of treatment at 3rd week and 6th week
Assessment of median nerve cross sectional area by ultrasonography	The median nerve cross-sectional area was measured by tracing just proximal to the carpal tunnel entrance with the wrist resting on a table in a neutral position. The carpal tunnel entrance was identified by detecting the proximal side of the transverse carpal ligament. The distal radioulnar joint was also observed at this level.	From enrollment to the end of treatment at 3rd week and 6th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of grip strength and lateral pinch strength	A hydraulic hand dynamometer was used to assess grip strength, and a hydraulic pinchmeter was used to assess lateral pinch strength. Measurements were made using the 2nd level resistance (3.75 cm) with the elbow at 90 degrees of flexion and the forearm and wrist in a neutral position. Patients were asked to squeeze with maximum force, measurements were made three times, and the average result was recorded in kilograms. For lateral pinch (LP), the pinchmeter was pressed with the distal middle of the thumb, and the lateral part of the second phalanx of the index finger was used to support the lower part.	From enrollment to the end of treatment at 3rd week and 6th week
Assessment of functionality	Duruöz Hand Index was used for functional assessment. This questionnaire contains 18 questions on hand activities. It consists of five areas. There are eight questions on kitchen activities, two questions on dressing, two questions on personal hygiene, two questions on office work and four questions on other activities. The patient selects one of the answers for each question on a scale of one to five. The scores given for each question are added to obtain a total score ranging from 0 to 90. Higher scores indicate more severe hand disability.	From enrollment to the end of treatment at 3rd week and 6th week
Assessment of neuropathic pain	Douleur Neuropathique 4 Questions was used to assessment of neuropathic pain. The DN4 questionnaire consists of 10 items. The first 7 items are related to pain characteristics and sensation, while the remaining 3 items are related to examination. For each item, a score of "1" is given if the answer is "yes" and a score of "0" if the answer is "no". If the total number of yes answers from the 10 items is calculated as 4 or more, the patient is defined as having neuropathic pain.	From enrollment to the end of treatment at 3rd week and 6th week
Assessment of quality of life	The Nottingham Health Profile was used.As a general health status questionnaire, it provides a brief indication of a patient's perceived emotional, social and physical health and is designed for use in the general population. It is concerned with the individual's health status and includes energy levels, pain, emotional responses, sleep, social isolation and physical abilities. The energy levels domain consists of 3 items, pain 8 items, emotional responses 9 items, sleep and social isolation domains 5 items each and physical abilities domain 8 items. Each item requires a yes or no response. The patient's score is calculated out of a total of 600 points. The higher the score, the lower the quality of life.	From enrollment to the end of treatment at 3rd week and 6th week
Assessment of depression	Beck Depression Inventory was used for depression assessment. It consists of 21 items with four precursors scored between 0 and 3. Patients are asked to mark the item that best suits their mood in the past week. As the score increases, it is thought that the depressive state is more severe. The total score is scored as 0-9 = Minimal, 10-16 = mild, 17-29 = moderate, 30-63 = severe.	From enrollment to the end of treatment at 3rd week and 6th week

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Study Director: Banu Kuran, Professor, MD, Şişli Hamidiye Etfal Training and Research Hospital, Deparment of Physical Medicine and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: February 22, 2025
• First Submitted That Met QC Criteria: February 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 22, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: extracorporeal shock wave therapy; carpal tunnel syndrome; kinesio taping
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Disease; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 26.09.2023/4106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No