High-intensity laser therapy for carpal tunnel syndrome

Evaluation of the Clinical, Sonographic, and Electrophysiological Efficacy of High-Intensity Laser Therapy (HILT) in Carpal Tunnel Syndrome

This trial will test whether high-intensity laser therapy helps adults 18–65 with mild-to-moderate carpal tunnel syndrome reduce pain and improve nerve function and hand strength compared with a sham procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ankara City Hospital Bilkent (Academic / other)
• Locations: 1 site (Ankara, Ankara, Çankaya)
• Trial ID: NCT07414069 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, double-blind, sham-controlled trial comparing Nd:YAG high-intensity laser therapy (HILT) to a sham HILT procedure in adults with electrophysiologically confirmed mild-to-moderate carpal tunnel syndrome. Participants aged 18–65 will be randomized to receive active or sham treatments and followed with clinical pain and function measures, grip strength testing, nerve conduction studies, and ultrasonographic measurement of median nerve cross-sectional area. The trial uses objective electrophysiological and sonographic endpoints in addition to patient-reported outcomes to determine whether HILT produces analgesic, anti-inflammatory, or biostimulatory effects. Study procedures are conducted at a single tertiary care center with blinded treatment delivery and outcome assessment.

Who should consider this trial

Good fit: Adults aged 18–65 with clinical symptoms and electrophysiological confirmation of mild-to-moderate carpal tunnel syndrome who can attend clinic visits and provide informed consent are ideal candidates.

Not a fit: Patients with severe carpal tunnel syndrome, prior carpal tunnel surgery, systemic causes of neuropathy (for example diabetes or hypothyroidism), recent steroid injection, or other peripheral neuropathies are unlikely to benefit or are excluded from participation.

Why it matters

Potential benefit: If successful, HILT could offer a noninvasive option to reduce pain and improve hand function and nerve conduction in people with mild-to-moderate carpal tunnel syndrome.

How similar studies have performed: Some small open-label and clinical reports suggest benefit from HILT, but sham-controlled, double-blind trials with objective nerve and ultrasound measures are limited.

Eligibility criteria

Inclusion Criteria:

* Age between 18 and 65 years
* Clinical symptoms consistent with carpal tunnel syndrome
* Electrophysiologically confirmed mild or moderate carpal tunnel syndrome
* Ability to comply with the study protocol and follow-up assessments
* Provided written informed consent

Exclusion Criteria:

* Severe carpal tunnel syndrome on electrophysiological examination
* Previous surgical treatment for carpal tunnel syndrome
* Local causes of carpal tunnel syndrome (e.g., mass lesions, ganglion cysts, tumors)
* Systemic conditions associated with carpal tunnel syndrome (e.g., diabetes mellitus, hypothyroidism, pregnancy, acromegaly)
* History of corticosteroid injection for carpal tunnel syndrome within the last 6 months
* Presence of polyneuropathy, radiculopathy, or other upper extremity peripheral nerve disorders
* Contraindications to electrophysiological testing or laser therapy
* Inability to complete follow-up assessments

Where this trial is running

Ankara, Ankara, Çankaya

• Ankara Bilkent City Hospital — Ankara, Ankara, Çankaya, Turkey (Türkiye) (Recruiting)

Study contacts

• Principal investigator: Filiz Eser, professor — Ankara City Hospital Bilkent
• Study coordinator: Ceren FINDIK KILIÇ

Conditions Carpal Tunnel Syndrome; High-Intensity Laser Therapy; HILT; Entrapment Neuropathy; Median Nerve