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

NCT06850779 | Completed

• 1 other identifier: 26.09.2023/4106
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

carpal tunnel syndrome; extracorporeal shock wave therapy; kinesio taping

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Assessment of grip strength and lateral pinch strength

  From enrollment to the end of treatment at 3rd week and 6th week

• Assessment of functionality

  From enrollment to the end of treatment at 3rd week and 6th week

• Assessment of neuropathic pain

  From enrollment to the end of treatment at 3rd week and 6th week

• Assessment of quality of life

  From enrollment to the end of treatment at 3rd week and 6th week

• Assessment of depression

  From enrollment to the end of treatment at 3rd week and 6th week

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Those who received both extracorporeal shock wave therapy (ESWT) and kinesio taping (KB)

Other: Extracorporeal shock wave therapy (ESWT); Other: Kinesio taping (KT); Other: Exercise

Group 2

ACTIVE COMPARATOR

Those who received ESWT

Other: Extracorporeal shock wave therapy (ESWT); Other: Exercise

Group 3

ACTIVE COMPARATOR

Those who received KT

Other: Kinesio taping (KT); Other: Exercise

Group 4

OTHER

Those who received only exercise

Other: Exercise

Interventions

Extracorporeal shock wave therapy (ESWT) OTHER

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.

Group 1; Group 2

Kinesio taping (KT) OTHER

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.

Group 1; Group 3

Exercise OTHER

Median nerve gliding exercises were given to the 4th group during the follow-up period. The same exercises were given to the other groups.

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Extracorporeal Shockwave Therapy; Exercise

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Banu Kuran, Professor, MD

  Şişli Hamidiye Etfal Training and Research Hospital, Deparment of Physical Medicine and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 27, 2025
• Study Start: October 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

TU (1)