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The Effect of ESWT in Carpal Tunnel Syndrome (ESWT)

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ESWT
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring ESWT

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with a diagnosis of mild to moderate CTS in the nerve conduction study within the last 1 month,
  • Positive Phalen and Tinnel tests in clinical examination
  • Who agreed to participate in the study

Exclusion Criteria:

  • Patients with cervical radiculopathy,
  • Pregnant women,
  • Rheumatoid arthritis,
  • Thenar atrophy,
  • Steroid injection or surgical procedure in the wrist in the last 3 months.

Sites / Locations

  • Ahmet Kıvanç Menekşeoğlu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ESWT Group

Control Group

Arm Description

A total of 5 sessions of ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the patients in this group for 2 weeks. Median nerve and tendon shifting exercises will be taught to the patients and they will be asked to do it regularly.

Patients in the control group will be asked to do median nerve and tendon shifting exercises only for the wrist.

Outcomes

Primary Outcome Measures

Boston carpal tunnel questionnaire
The functional levels of the patients will be evaluated with the Boston carpal tunnel questionnaire.

Secondary Outcome Measures

Visual Analog Scale
The pain level of the patients will be evaluated with visual analog scale. The visual analog scale is scored between 0 and 10. Increased scores mean more pain.
Median nerve conduction study
Median nerve conduction velocity will be evaluated by ENMG.

Full Information

First Posted
May 13, 2021
Last Updated
March 16, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04896398
Brief Title
The Effect of ESWT in Carpal Tunnel Syndrome
Acronym
ESWT
Official Title
Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
50 patients who meet the inclusion criteria will be included in this prospective, randomized and controlled study. Demographic information of the patients will be taken and recorded. After the patients are numbered according to the order of application, they will be divided into 2 groups as study and control groups according to randomization with the computer program. A total of 5 sessions of ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the study group (1st group) for 2 weeks. Patients will be taught median nerve and tendon shifting exercises and will be asked to do it regularly. Patients in the control group (Group 2) will be asked to perform median nerve and tendon shifting exercises only for the wrist. Patients will be evaluated before treatment, at 4 and 12 weeks after treatment. In the evaluation, Boston Carpal Tunnel Inquiry Form, pain severity assessment with VAS (visual analog scale), neuropathic pain intensity with LANSS scale and median nerve conduction velocity with EMG will be evaluated.
Detailed Description
Carpal tunnel syndrome is a clinical picture that occurs with a group of symptoms and signs as a result of compression and compression in the carpal tunnel where the median nerve passes to the wrist. Another name is hand-wrist canal disease, the most common entrapment is neuropathy. It is generally observed in individuals between the ages of 40-60, its prevalence is 4-5%, and it is 3 times more common in women than men. Clinical signs 1.-2.-3. numbness, tingling, abduction and positioning of the thumb, pain in the wrist and inner part of the hand, autonomic symptoms (heat or discoloration, dry skin) worsening of symptoms due to provocative factors (forcing the wrist to flex). Loss of strength and atrophy of the palm muscles occur in the later stages. The diagnosis is made by clinical examination, electrophysiological methods (EMG) and imaging methods (such as ultrasound, magnetic resonance imaging). Clinical examination consists of sensory motor examination and provocative tests. Treatment is divided into conservative and surgical. Among the conservative treatment methods, splinting, exercise (sliding movements of the median nerve and wrist flexor tendons in the wrist), local corticosteroid injection (corticosteroid injection into the carpal tunnel), ultrasound (warming the deep tissues with sound energy), TENS (electrodes placed on the skin). pain relief by applying controlled low-voltage electric current to the nervous system through the skin), paraffin bath (immersion of the hand in a pool of heat-melted paraffin), ergonomic arrangements. ESWT is a widely used treatment method in the treatment of carpal tunnel syndrome in recent years. ESWT is called "Extracorporeal Shock Wave Therapy", in Turkish "Shock Wave Therapy Applied Outside the Body" or simply "Shock Wave Therapy". It is a treatment method based on the principle of focusing the shock (pressure) waves created outside the body to the desired area of the body by means of a steel-headed applicator. Shock waves are single pulsatile acoustic waves of high amplitude. It reaches high pressure (100Mpa) and then negative pressure (5-10 Mpa) in a short time expressed in nanoseconds (10 ns). This device was first applied in the destruction of urinary stones in the 1980s. In the following years, it has been used in cases such as shoulder calcific tendinitis, lateral epicondylitis, plantar fasciitis, and fracture healing. Currently indications for ESWT are non-union fractures, revision arthroplasties, lateral epicondylitis, plantar fascitis, calcified tendinitis of the shoulder, avascular necrosis of the femoral head, Achilles tendinitis, patellar tendinitis, myofascial pain syndrome, ischemic heart disease, peyronia disease, chronic diabetic heart disease. It covers a wide range of disease groups such as ulcers, knee osteoarthritis, complex regional pain syndrome, carpal tunnel syndrome. Studies have shown that ESWT increases angiogenesis, neovascularization, anti-inflammatory growth factor release, progenitor and stem cell activation. Morphological changes were detected in cutaneous sensory nerve fibers with shock wave application on the nerves. It has been observed that there is a relationship between reduction of PGP 9.5 (protein gene product) and CGRP (calcitonin gene-related peptide) and pain reduction following shock application in sensory nerve fibers in the epidermal region. At the same time, integrin molecules are secreted for axonal growth with shock application and this continues cumulatively with ESWT application. GAP 43 (growth associated phosphoprotein) molecule, which is a marker related to axonal regeneration and which is highly expressed especially during neuron development and axonal 3/10 elongation, has been found to increase after ESWT application. In this study, it was aimed to investigate the effectiveness of ESWT treatment applied to patients diagnosed with mild to moderate carpal tunnel syndrome by EMG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
ESWT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After the patients are numbered according to the order of application, they will be divided into 2 groups as study and control groups according to randomization made with the computer program (block randomization). A total of 5 sessions of ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the study group (1st group) for 2 weeks. Median nerve and tendon shifting exercises will be taught to the patients and they will be asked to do it regularly. Patients in the control group (Group 2) will be asked to perform median nerve and tendon shifting exercises only for the wrist. Patients will be evaluated before treatment and at 4 and 12 weeks after treatment.
Masking
Investigator
Masking Description
The evaluation of the patients will be made by an evaluator who has no knowledge of group distribution.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESWT Group
Arm Type
Experimental
Arm Description
A total of 5 sessions of ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the patients in this group for 2 weeks. Median nerve and tendon shifting exercises will be taught to the patients and they will be asked to do it regularly.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients in the control group will be asked to do median nerve and tendon shifting exercises only for the wrist.
Intervention Type
Device
Intervention Name(s)
ESWT
Intervention Description
In the study group, a total of 5 sessions of focused ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the affected wrist within 2 weeks.
Primary Outcome Measure Information:
Title
Boston carpal tunnel questionnaire
Description
The functional levels of the patients will be evaluated with the Boston carpal tunnel questionnaire.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
The pain level of the patients will be evaluated with visual analog scale. The visual analog scale is scored between 0 and 10. Increased scores mean more pain.
Time Frame
3 months
Title
Median nerve conduction study
Description
Median nerve conduction velocity will be evaluated by ENMG.
Time Frame
3 months

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: Patients with a diagnosis of mild to moderate CTS in the nerve conduction study within the last 1 month, Positive Phalen and Tinnel tests in clinical examination Who agreed to participate in the study Exclusion Criteria: Patients with cervical radiculopathy, Pregnant women, Rheumatoid arthritis, Thenar atrophy, Steroid injection or surgical procedure in the wrist in the last 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet K Menekşeoğlu
Organizational Affiliation
Kanuni Sultan Süleyman Research and Training Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmet Kıvanç Menekşeoğlu
City
Istanbul
ZIP/Postal Code
34015
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Identity information of the patients other than their gender, age and BMI will not be shared.

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The Effect of ESWT in Carpal Tunnel Syndrome

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