High Intensity Laser Therapy in Carpal Tunnel Syndrome

Afyonkarahisar Health Sciences University

Status: Completed

Conditions: Entrapment Neuropathy; Carpal Tunnel Syndrome; Musculoskeletal Diseases; Median Neuropathy

Treatments: Device: High-intensity laser therapy (HILT); Device: Sham High-intensity laser therapy (sham HILT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04949373

Afyonkarahisar Health Sciences

Details and patient eligibility

About

This research aims to investigate the effect of high-intensity laser therapy on pain, function, nerve conduction studies and grip strength in patients with idiopathic carpal tunnel syndrome.

Full description

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, and it causes numbness and tingling in the hand, atrophy and muscle weakness in the later stages. Any condition that increases the volume of the carpal tunnel and narrows the diameter of the tunnel may increase the compression of the median nerve under the transverse carpal ligament and cause symptoms. In majority of cases, no cause can be found and it is called "idiopathic".

While the diagnosis of CTS is made by the patient's history and physical examination methods, the diagnosis is confirmed with use of electrophysiological examination. Physical therapy, non-steroidal anti-inflammatory drug use, local steroid injection, hand-wrist rest splint, nerve/tendon gliding exercises; Physiotherapy modalities such as therapeutic ultrasound and laser are among the conservative treatment methods of CTS. Despite the effectiveness of surgery in the treatment of severe CTS cases, as is known, surgical treatment is not without risk. Therefore, mild to moderate CTS is treated conservatively.

Laser therapy is one of the physical therapy modalities, low-intensity laser therapy (LILT), whose biological effects occur secondary to direct photochemical effect and are not the result of thermal effects. High-intensity laser therapy (HILT), which has been widely used recently, is frequently used since it has small and slow light absorption from chromophores. HILT is not a concentrated light, but it diffuses in all directions (scattering phenomenon). This supports the wider effectiveness of HILT. HILT also has effects such as increased mitochondrial oxidative reactions, increased production of adenosine triphosphate, RNA and DNA (photochemical effect), increased tissue stimulation (photobiological), and reduced pain and inflammation. HILT, which has recently found many uses in musculoskeletal diseases, can affect a wider and deeper area in the tissues compared to the widely used LILT. Although there are many studies on the effectiveness of LILT therapy in CTS, there are few trials to study the effectiveness of HILT on clinical and electrophysiological parameters in CTS.

This investigation is designed as double-blind prospective sham controlled randomized study.

Participants were randomized into 2 groups: 1) HILT + nerve/tendon gliding exercises + rest splint and 2) Sham HILT+ nerve/tendon gliding exercises + rest splint

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild or moderate idiopathic carpal tunnel syndrome (clinically diagnosed and electrophysiologically confirmed CTS)

Exclusion criteria

• Diabetes mellitus,hypothyroidism, rheumatic diseases, acromegaly
• Polyneuropathy,
• Ipsilateral brachial plexopathy and traumatic nerve injury of the upper extremity
• Previous injection into the carpal tunnel and physical therapy within in the preceding 6 months
• Pregnancy
• History of malignancy
• Patients with cochlear implants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

HILT+nerve/tendon gliding exercise+rest splint

Experimental group

Description:

Patients will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for three weeks (one session per day for a total of 15 sessions). A 3-phase treatment program will be performed in each session, and a physiotherapist will then apply nerve/tendon gliding exercises program to the patients once daily. The patients will use rest splint at night.

Treatment:

Device: High-intensity laser therapy (HILT)

Sham HILT+nerve/tendon gliding exercise+rest splint

Sham Comparator group

Description:

Patients will receive sham laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for three weeks (one session per day for a total of 15 sessions). A 3-phase treatment program will be performed in each session, and a physiotherapist will then apply nerve/tendon gliding exercises program to the patients once daily . The patients will use rest splint at night.

Treatment:

Device: Sham High-intensity laser therapy (sham HILT)