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Efficacy of Extracorporeal Shock Wave Therapy in Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Low dose ESWT application
High dose ESWT application
Sham ESWT
Exercise Training
Sponsored by
University of Beykent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, Extracorporeal Shockwave Therapy, Median Neuropathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Gaziosmanpasa Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Low dose ESWT application group

High dose ESWT group

Control group

Arm Description

Exercise Training Low dose ESWT application

Exercise Training High dose ESWT application

Exercise Training Sham ESWT

Outcomes

Primary Outcome Measures

Boston Carpal Tunnel Syndrome Questionnaire
The boston carpal tunnel syndrome questionnaire will be used to measure the severity of the disease and the level of functionality.

Secondary Outcome Measures

Hand Grip Force
Hand grip strength will be measured with a Jamar dynamometer.
Nerve Conduction Velocity
The conduction velocity of the median nerve will be measured according to the American Academy of Neurology
Short Form- 36
The quality of life of the patients will be evaluated with short form 36.
Visual analog scale
The pain intensity felt by the participants during rest and activity, respectively, will be evaluated by VAS

Full Information

First Posted
March 29, 2022
Last Updated
May 30, 2022
Sponsor
University of Beykent
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1. Study Identification

Unique Protocol Identification Number
NCT05314777
Brief Title
Efficacy of Extracorporeal Shock Wave Therapy in Carpal Tunnel Syndrome
Official Title
Comparison of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) at Different Pulse Numbers in Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
August 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Beykent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Syndrome, Extracorporeal Shockwave Therapy, Median Neuropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose ESWT application group
Arm Type
Experimental
Arm Description
Exercise Training Low dose ESWT application
Arm Title
High dose ESWT group
Arm Type
Experimental
Arm Description
Exercise Training High dose ESWT application
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Exercise Training Sham ESWT
Intervention Type
Procedure
Intervention Name(s)
Low dose ESWT application
Intervention Description
Patients trained for low dose ESWT application.
Intervention Type
Procedure
Intervention Name(s)
High dose ESWT application
Intervention Description
Patients trained for high dose ESWT application.
Intervention Type
Procedure
Intervention Name(s)
Sham ESWT
Intervention Description
Patients trained for sham ESWT.
Intervention Type
Procedure
Intervention Name(s)
Exercise Training
Intervention Description
Patients trained for exercise training.
Primary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire
Description
The boston carpal tunnel syndrome questionnaire will be used to measure the severity of the disease and the level of functionality.
Time Frame
First month- Third month
Secondary Outcome Measure Information:
Title
Hand Grip Force
Description
Hand grip strength will be measured with a Jamar dynamometer.
Time Frame
First month- Third month
Title
Nerve Conduction Velocity
Description
The conduction velocity of the median nerve will be measured according to the American Academy of Neurology
Time Frame
First month- Third month
Title
Short Form- 36
Description
The quality of life of the patients will be evaluated with short form 36.
Time Frame
First month- Third month
Title
Visual analog scale
Description
The pain intensity felt by the participants during rest and activity, respectively, will be evaluated by VAS
Time Frame
First month- Third month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasemin Karaaslan, Ph.D.
Phone
05358459625
Email
ptyasemindeveci@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin Karaaslan, Ph.D.
Organizational Affiliation
Beykent University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatih Ozyurt, Pt
Organizational Affiliation
Beykent University
Official's Role
Study Chair
Facility Information:
Facility Name
Gaziosmanpasa Training and Research Hospital
City
İstanbul
ZIP/Postal Code
34488
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasemin Karaaslan
Email
ptyasemindeveci@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Extracorporeal Shock Wave Therapy in Carpal Tunnel Syndrome

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