Comparison of Low-intensity Laser and ESWT in Carpal Tunnel Syndrome

NCT ID: NCT05589805

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-30
• Study Completion Date: 2023-10-30

Brief Summary

Carpal tunnel syndrome is the most common neuropathy of the median nerve. Conservative methods are used in mild and moderate CTS in the treatment. In this study, we aimed to compare the effectiveness of low-intensity laser and ESWT treatments in patients with mild and moderate carpal tunnel syndrome diagnosed with EMG.

Detailed Description

Carpal tunnel syndrome is the most common neuropathy of the median nerve. Its incidence increases between the ages of 40-60. Its prevalence is 4-5%, and incidence is 2.7%. It is more common in women than men. The vast majority of cases are idiopathic.The first symptoms usually start at night. The patient wakes up with a feeling of swelling without any visible swelling and symptoms such as burning, numbness and tingling in the median nerve region.In severe cases, hand weakness and thenar atrophy develop. Provocative tests such as phalen, reverse phalen, tinel, carpal compression test, tourniquet test can be used in the examination.The diagnosis of carpal tunnel syndrome is made by nerve conduction studies and electromyography. Conservative methods are used in mild and moderate CTS in the treatment. Surgical methods are recommended in severe cases and in cases unresponsive to conservative treatment.One of the methods used in the treatment is Laser (Light Amplification by Stimulated Emission of Radiation).There are low and high intensity laser applications according to their energy densities. The basic mechanism of action is tissue stimulation. ESWT (Extracorporeal Shock Wave Therapy), another treatment method, shows therapeutic properties by focusing high-amplitude sound waves on the desired area of the body. Apart from the mechanical effect, it also has an effect at the cellular level.In previous studies, both low-intensity laser and ESWT application were found to be effective in the treatment of carpal tunnel syndrome. However, as far as we know, there is no study comparing the efficacy of low-intensity laser therapy and ESWT therapy in carpal tunnel syndrome. In this study, we aimed to compare the effectiveness of low-intensity laser and ESWT treatments in patients with mild and moderate carpal tunnel syndrome diagnosed with EMG.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESWT group

In addition to wrist splint, ESWT treatment (1.5 bar, 5Hz, 1000 beats) will be applied to the patients with the Elmed Vibrolith Ortho brand ESWT device, which we routinely use in the treatment of carpal tunnel syndrome, for 3 weeks, once a week.

Group Type: EXPERIMENTAL

Extracorporeal shock wave therapy

Intervention Type: DEVICE

In addition to wrist splint, ESWT treatment (1.5 bar, 5Hz, 1000 beats) will be applied to the patients with Elmed Vibrolith Ortho brand ESWT device, which we routinely use in the treatment of carpal tunnel syndrome, for 3 weeks, once a week.

Laser group

In addition to the wrist splint, the patients will be treated with the BTL-4110 Laser Topline model low-intensity laser device, which we routinely use in the treatment of carpal tunnel syndrome in our hospital, 5 days a week for 15 sessions of laser treatment.

Group Type: EXPERIMENTAL

Laser therapy

Intervention Type: DEVICE

In addition to the wrist splint, the patients will be treated with the BTL-4110 Laser Topline model low-intensity laser device, which we routinely use in the treatment of carpal tunnel syndrome in our hospital, 5 days a week for 15 sessions of laser treatment.

Control group

Patients will only be given a wrist splint to keep the wrist in neutral position.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

Patients will only be given a wrist splint to keep the wrist in neutral position.

Interventions

Extracorporeal shock wave therapy

In addition to wrist splint, ESWT treatment (1.5 bar, 5Hz, 1000 beats) will be applied to the patients with Elmed Vibrolith Ortho brand ESWT device, which we routinely use in the treatment of carpal tunnel syndrome, for 3 weeks, once a week.

Intervention Type: DEVICE

Laser therapy

In addition to the wrist splint, the patients will be treated with the BTL-4110 Laser Topline model low-intensity laser device, which we routinely use in the treatment of carpal tunnel syndrome in our hospital, 5 days a week for 15 sessions of laser treatment.

Intervention Type: DEVICE

Control group

Patients will only be given a wrist splint to keep the wrist in neutral position.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18-65 years
• Having a clinic compatible with carpal tunnel syndrome,
• Patients with electrophysiological data compatible with mild and moderate carpal tunnel syndrome

Exclusion Criteria

• Cervical radiculopathy , polyneuropathy , brachial plexopathy , thoracic outlet syndrome
• Regular use of oral steroids or nsaii in the last 3 months
• Systemic disease (DM, hypothyroidism, RA, gout, acromegaly, CKD, dialysis)
• Severe carpal tunnel syndrome (kts)

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

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Elif yaksi

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AIBU-FTR-EY-07

Identifier Type: -

Identifier Source: org_study_id