Comparison of Rest Splints vs High-Intensity Laser Therapy in Carpal Tunnel Syndrome

Afyonkarahisar Health Sciences University

Status: Enrolling

Conditions: Carpal Tunnel Syndrome (CTS)

Treatments: Device: Rest splint group; Device: high-intensity laser therapy (HILT); Device: sham high-intensity laser therapy (HILT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07294157

2024-KAEK-09

Details and patient eligibility

About

The aim of this study is to compare the effectiveness of rest splints and high-intensity laser therapy(HILT) added to physical therapy programs for patients with carpal tunnel syndrome in terms of pain, function, nerve conduction studies, and grip strength.

Full description

Carpal tunnel syndrome (CTS) is the most common entrapment nerve compression, causing numbness and tingling in the hand, atrophy and muscle weakness in advanced stages. Any condition that increases the volume of the carpal tunnel and narrows the diameter of the tunnel can increase the compression of the median nerve under the transverse carpal ligament and cause symptoms. The use of a wrist splint or wrist brace is a common method of non-surgical treatment of carpal tunnel syndrome. The wrist splint is designed to allow rotation and supination, while eliminating the possibility of extension, flexion and radial-ulnar deviation.High-intensity laser therapy is used to provide symptomatic relief and reduce pain-related inflammation. The soothing effect of the laser is remarkable, especially in acute cases, but in the case of chronic disorders, the pain may be aggravated after the first treatments and is continued only if it decreases.

This study was designed as a prospective randomised controlled trial. Participants were randomised into 3 groups. The 1st group will receive wrist range of motion exercises, isometric strengthening, intrinsic muscle strengthening, wrist stretching, desensitization exercises, tendon sliding exercises, median nerve sliding exercises, wrist flexion and extension exercises, grip strengthening exercises and resting splint application for 6 weeks, 5 days a week, 30 sessions in total. The 2nd group (HILT group) will be given high intensity laser therapy 5 days a week for 6 weeks (30 sessions in total) in addition to the physical therapy program. The 3rd group will be the sham HILT group and physical therapy exercises will be applied like the other groups.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-75 years who have been diagnosed with carpal tunnel syndrome based on their medical history, physical examination, clinical findings, and electromyography(EMG) results, who have applied to the outpatient clinic for physical therapy, and who have no contraindications for treatment will be included in the study after obtaining their consent.

Exclusion criteria

• Diabetes Mellitus
• Hypothyroidism
• Acromegaly
• Rheumatic Diseases
• Polyneuropathy
• Ipsilateral brachial plexopathy and traumatic nerve injury in the upper extremity
• Previous injection into the carpal tunnel within the last 6 months and physical therapy
• Pregnancy
• History of malignant tumors
• Patients with cochlear implants
• Acquired Immunodeficiency Syndrome
• History of neck and/or shoulder surgery
• Corticosteroid consumption, analgesic medication use
• Epilepsy
• Skin lesion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

Experimental: 1. Group (rest splint group)

Experimental group

Description:

The physical therapy program we routinely provide to patients with carpal tunnel syndrome in our physical therapy unit (wrist ROM isometric strengthening, intrinsic muscle strengthening, wrist stretching, desensitization exercises, tendon gliding exercises, median nerve gliding exercises, wrist flexion and extension exercises, grip strengthening exercises) will be provided to patients with carpal tunnel syndrome in our physical therapy unit. Patients will be instructed to use a splint for rest as much as possible during the day and for as long as possible at night for a period of 6 weeks.

Treatment:

Device: Rest splint group

Experimental: Group 2 (high-intensity laser therapy (HILT))

Experimental group

Description:

This group will receive high-intensity laser therapy applied over the carpal tunnel region. HILT delivers deep tissue photothermal and photomechanical effects, promoting tissue repair and reducing inflammation. The treatment is expected to decrease pain and improve nerve conduction and grip strength.

Treatment:

Device: high-intensity laser therapy (HILT)

Sham Comparator: Group 3 (sham high-intensity laser therapy (HILT) )

Sham Comparator group

Description:

Participants in this group will undergo a placebo laser treatment using the same device without active laser emission. The procedure will mimic the real HILT application to ensure blinding. This group will help distinguish the true therapeutic effects of HILT from placebo responses.

Treatment:

Device: sham high-intensity laser therapy (HILT)