Efficacy of Extracorporeal Shock Wave Therapy in Carpal Tunnel Syndrome

NCT ID: NCT05314777

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2022-12-20

Brief Summary

The aim of the study is to examine the effects of ESWT applications at different pulse rates on pain, function, grip strength and median nerve conduction velocity in patients with Carpal Tunnel Syndrome. The patients will be randomly divided into 3 groups: the low dose ESWT group (28), the high dose ESWT group (28), and the control group (28). The first two groups will receive ESWT treatment at different doses, while the control group will be treated with sound only (1 time/week-3 weeks).

Detailed Description

The aim of the study is to examine the effects of ESWT applications at different pulse rates on pain, function, grip strength and median nerve conduction velocity in patients with Carpal Tunnel Syndrome. The sample of the study will consist of patients with carpal tunnel syndrome who were diagnosed in Gaziosmapaşa Training and Research Hospital between April 2022 and December 2022 and whose symptoms have persisted for at least 3 months. The patients will be randomly divided into 3 groups: the low dose ESWT group (28), the high dose ESWT group (28), and the control group (28). The first two groups will receive ESWT treatment at different doses, while the control group will be treated with sound only (1 time/week-3 weeks). The evaluation of the patients participating in the study will be made by the physician who is not aware of the groups. Evaluations will be made 3 times before the treatment, at the 1st month and at the 3rd month. In the evaluation, Boston Carpal Tunnel Syndrome Questionnaire to evaluate symptoms and functionality, visual analog scale (VAS) to evaluate pain, SF-36 to evaluate quality of life, hand dynamometer to evaluate grip strength and electrodiagnostic examination to evaluate median nerve conduction velocity will be performed. After the initial evaluations, the patients participating in the study will be randomly divided into 3 groups. Tendon shifting and nerve shifting exercises will be performed in all groups. ESWT will be applied to 2 groups at different beat numbers. One session of ESWT will be applied to both groups each week for 3 consecutive weeks. In addition to the exercises in the low dose ESWT group, 1000 beats at a pressure of 4 bar and a frequency of 5 Hz will be applied on the ESWT carpal tunnel. In addition to the exercises in the high-dose ESWT group, 2000 beats at a pressure of 4 bar and a frequency of 5 Hz will be applied on the ESWT carpal tunnel. In the control group, in addition to the exercises, sham ESWT will be applied. No energy will be used in Sham ESWT application, only sound will be given. Each group will be given a 15-minute cold-pack application after the ESWT application. The exercises will be taught to the patient before the first ESWT application and the exercises will be given to the patients in brochure form. These exercises will be given to the patient as home exercises. You will be asked to do these exercises at home in 2 sets of 5 repetitions 2 times a day. Tendon gliding exercises are performed with the fingers in 5 different positions as regular grip, hook grip, fist, desktop and normal fist. In the distal median nerve gliding exercise, firstly, in the neutral position of the wrist, the fingers and thumb are flexed, in the second position, all the fingers are in the neutral position, in the third position, when the thumb is in the neutral position, the wrist and other fingers are in extension, in the fourth position, the wrist, thumb and other fingers are in extension, In the fifth position, when the wrist and fingers are in the same position, the forearm is in supination, in the sixth position, in the fifth position, the thumb stretching is applied.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low dose ESWT application group

Exercise Training Low dose ESWT application

Group Type: EXPERIMENTAL

Low dose ESWT application

Intervention Type: PROCEDURE

Patients trained for low dose ESWT application.

Exercise Training

Intervention Type: PROCEDURE

Patients trained for exercise training.

High dose ESWT group

Exercise Training High dose ESWT application

Group Type: EXPERIMENTAL

High dose ESWT application

Intervention Type: PROCEDURE

Patients trained for high dose ESWT application.

Exercise Training

Intervention Type: PROCEDURE

Patients trained for exercise training.

Control group

Exercise Training Sham ESWT

Group Type: ACTIVE_COMPARATOR

Sham ESWT

Intervention Type: PROCEDURE

Patients trained for sham ESWT.

Exercise Training

Intervention Type: PROCEDURE

Patients trained for exercise training.

Interventions

Low dose ESWT application

Patients trained for low dose ESWT application.

Intervention Type: PROCEDURE

High dose ESWT application

Patients trained for high dose ESWT application.

Intervention Type: PROCEDURE

Sham ESWT

Patients trained for sham ESWT.

Intervention Type: PROCEDURE

Exercise Training

Patients trained for exercise training.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Being between the ages of 18-65,

• Clinical symptoms persisting for at least 3 months
• Pain, tingling and paresthesia in the first 3 fingers together with the Phalen and Tinel test makes the patient positive,
• Patients who are positive are evaluated by a specialist in electrodiagnostic testing and the clinical stage of CTS is determined.
• Mild to moderate CTS is diagnosed if the sensory nerve action potential (SNAP) is >6 μV and the combined muscle action potential (CMAP) is >2.1 mV.
• Being diagnosed with mild and moderate CTS

Exclusion Criteria

• The patient who received CTS operation or corticosteroid treatment,
• Presence of systemic diseases that will affect our treatment such as diabetes, rheumatoid arthritis, gout,
• It has been determined as atrophy in the thenar region of the hand (Xu,2020).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Beykent

OTHER

Sponsor Role: lead

Responsible Party

Yasemin Karaaslan

Ph.D. Pt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasemin Karaaslan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Beykent University

Fatih Ozyurt, Pt

Role: STUDY_CHAIR

Beykent University

Locations

Gaziosmanpasa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Yasemin Karaaslan, Ph.D.

Role: CONTACT

ptyasemindeveci@gmail.com

05358459625

Facility Contacts

Yasemin Karaaslan

Role: primary

ptyasemindeveci@gmail.com

Other Identifiers

02032022

Identifier Type: -

Identifier Source: org_study_id