Rest splints versus high-intensity laser therapy for carpal tunnel syndrome
Comparison of the Effects of Rest Splints and High-Intensity Laser Therapy on Pain, Function, Nerve Conduction Studies, and Grip Strength in Patients With Carpal Tunnel Syndrome
This project will test whether adding high-intensity laser therapy or using rest splints alongside physical therapy helps people with carpal tunnel syndrome reduce pain and improve hand function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Afyonkarahisar Health Sciences University Academic / other |
| Locations | 2 sites (Afyonkarahisar and 1 other locations) |
| Trial ID | NCT07294157 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized controlled trial that assigns participants with electromyography-confirmed carpal tunnel syndrome to one of three groups: a rest-splint plus physical therapy program, high-intensity laser therapy (HILT) plus the same physical therapy program, or sham HILT plus the same program. The active treatments are delivered over six weeks with sessions five days per week (30 sessions total) and include range-of-motion, strengthening, nerve- and tendon-sliding, stretching, and desensitization exercises. Outcomes include pain, hand function, grip strength, and nerve conduction study parameters. The trial compares symptom and objective nerve changes between splinting and laser approaches when added to a standardized exercise-based rehabilitation protocol.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 years old with clinically and electromyographically confirmed carpal tunnel syndrome who can attend outpatient physical therapy and have no contraindications to the treatments.
Not a fit: Patients with excluded conditions such as diabetes, hypothyroidism, polyneuropathy, prior recent carpal tunnel injections or physical therapy, pregnancy, cochlear implants, epilepsy, or recent neck/shoulder surgery are not eligible and therefore will not receive benefit from participation in this trial.
Why it matters
Potential benefit: If successful, the trial could identify a non-surgical option that reduces pain and improves hand strength and nerve function for people with carpal tunnel syndrome.
How similar studies have performed: Wrist splints are an established conservative treatment for carpal tunnel syndrome, while prior studies of laser therapies (including lower- and higher-intensity lasers) have shown mixed results, so the approach has some precedent but is not conclusively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Afyonkarahisar and 1 other locations
- Afyonkarahisar Health Science University — Afyonkarahisar, Turkey (Türkiye) (Not_yet_recruiting)
- Afyonkarahisar Health Sciences Unıversity — Afyonkarahisar, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Ümit DÜNDAR, Profesor — Afyonkarahi̇sar Health Sci̇ences Uni̇versity
- Study coordinator: Ümit DÜNDAR, Profesor
- Email: umitftr@yahoo.com
- Phone: 05337494526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.