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Recruiting Not applicable

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

NCT07294157 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-12-15
Last updated
2026-01-13

Condition(s) studied

Carpal Tunnel Syndrome (CTS)

Investigational drug(s) / intervention(s)

Rest splint grouphigh-intensity laser therapy (HILT)sham high-intensity laser therapy (HILT)

Rest splint group: We routinely provide the following physical therapy program to patients with carpal tunnel syndrome in our physical therapy unit: hand wrist ROM isometric strengthening, intrinsic muscle strengthening, hand 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, and they will be instructed to use the resting splint as much as possible during the day and maximally at night for 6 weeks. Rest splint: The WingMed brand splint is specially designed to hold the wrist in a neutral position with volar support, allowing pronation and supination of the wrist but not allowing flexion, extension, radial, or ulnar deviation.

high-intensity laser therapy (HILT): Group 2 (high-intensity laser therapy (HILT)) will undergo pulsed laser therapy using the HIRO 3 device (ASA Laser, Arcugnano, Italy) five times a week for 6 weeks (a total of 30 sessions, one session per day) in addition to the physical therapy program. During each session, a three-phase treatment program will be administered to patients once a day, accompanied by a physical therapist, consisting of nerve/tendon gliding exercises.

sham high-intensity laser therapy (HILT): The sham-HILT group will receive sham laser therapy using the HIRO 3 device (ASA Laser, Arcugnano, Italy) five times a week for six weeks (a total of 30 sessions, one session per day) in addition to the physical therapy program. After patients see that the device is turned on during the sham application, the same treatment will be applied to the same treatment area for the same duration without allowing laser current output from the device.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Visual Analog Scale (VAS): — Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)
    Patients' musculoskeletal pain intensity was assessed using the visual analog scale (VAS). The meanings of the numbers placed on a 10 cm line from 0 to 10 were explained to the patients. It was explained that no pain was 0, the most severe pain ever experienced was 10, and moderate pain was 5 points. Based on these explanations, patients were asked to rate their pain levels for the past week.

Trial sites (2)

FacilityCityRegionStatus
Afyonkarahisar Health Science University Afyonkarahisar Turkey (Türkiye) Not Yet Recruiting
Afyonkarahisar Health Sciences Unıversity Afyonkarahisar Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07294157 on ClinicalTrials.gov ↗ ← All trials in Turkey