Efficacy of Extracorporeal Shock Wave Therapy in Carpal Tunnel Syndrome

Sponsor
University of Beykent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05314777
Collaborator
(none)
60
1
3
6.7
9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Low dose ESWT application
  • Procedure: High dose ESWT application
  • Procedure: Sham ESWT
  • Procedure: Exercise Training
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Comparison of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) at Different Pulse Numbers in Carpal Tunnel Syndrome
Actual Study Start Date :
May 30, 2022
Anticipated Primary Completion Date :
Aug 20, 2022
Anticipated Study Completion Date :
Dec 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low dose ESWT application group

Exercise Training Low dose ESWT application

Procedure: Low dose ESWT application
Patients trained for low dose ESWT application.

Procedure: Exercise Training
Patients trained for exercise training.

Experimental: High dose ESWT group

Exercise Training High dose ESWT application

Procedure: High dose ESWT application
Patients trained for high dose ESWT application.

Procedure: Exercise Training
Patients trained for exercise training.

Active Comparator: Control group

Exercise Training Sham ESWT

Procedure: Sham ESWT
Patients trained for sham ESWT.

Procedure: Exercise Training
Patients trained for exercise training.

Outcome Measures

Primary Outcome Measures

  1. Boston Carpal Tunnel Syndrome Questionnaire [First month- Third month]

    The boston carpal tunnel syndrome questionnaire will be used to measure the severity of the disease and the level of functionality.

Secondary Outcome Measures

  1. Hand Grip Force [First month- Third month]

    Hand grip strength will be measured with a Jamar dynamometer.

  2. Nerve Conduction Velocity [First month- Third month]

    The conduction velocity of the median nerve will be measured according to the American Academy of Neurology

  3. Short Form- 36 [First month- Third month]

    The quality of life of the patients will be evaluated with short form 36.

  4. Visual analog scale [First month- Third month]

    The pain intensity felt by the participants during rest and activity, respectively, will be evaluated by VAS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gaziosmanpasa Training and Research Hospital İstanbul Turkey 34488

Sponsors and Collaborators

  • University of Beykent

Investigators

  • Principal Investigator: Yasemin Karaaslan, Ph.D., Beykent University
  • Study Chair: Fatih Ozyurt, Pt, Beykent University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yasemin Karaaslan, Ph.D. Pt., University of Beykent
ClinicalTrials.gov Identifier:
NCT05314777
Other Study ID Numbers:
  • 02032022
First Posted:
Apr 6, 2022
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yasemin Karaaslan, Ph.D. Pt., University of Beykent
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2022