The Effect of ESWT in Carpal Tunnel Syndrome

NCT ID: NCT04896398

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-11-01

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESWT Group

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.

Group Type: EXPERIMENTAL

ESWT

Intervention Type: DEVICE

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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ESWT

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.

Intervention Type: DEVICE

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.

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

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Kivanc Menekseoglu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmet K Menekşeoğlu

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Süleyman Research and Training Hospital

Locations

Ahmet Kıvanç Menekşeoğlu

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021-1

Identifier Type: -

Identifier Source: org_study_id