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

NCT07294157 | Recruiting

• 1 other identifier: 2024-KAEK-09
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Carpal Tunnel Syndrome; Physical Therapy Modalities; Electromyography veya Nerve Conduction

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS):

  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.

  Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)

Secondary Outcomes (12)

• Boston Carpal Tunnel Questionnaire:

  Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)

• LANSS neuropathic pain assessment scale

  Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)

• Quick DASH Questionnaire

  Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)

• Median nerve distal motor latency

  Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)

Study Arms (3)

Experimental: 1. Group (rest splint group)

EXPERIMENTAL

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.

Device: Rest splint group

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

EXPERIMENTAL

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.

Device: high-intensity laser therapy (HILT)

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

SHAM COMPARATOR

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.

Device: sham high-intensity laser therapy (HILT)

Interventions

Rest splint group DEVICE

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.

Experimental: 1. Group (rest splint group)

high-intensity laser therapy (HILT) DEVICE

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.

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

sham high-intensity laser therapy (HILT) DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (2)

Afyonkarahisar Health Science University

Afyonkarahisar, 0300, Turkey (Türkiye)

NOT YET RECRUITING

Afyonkarahisar Health Sciences Unıversity

Afyonkarahisar, 0300, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Ashour AA, Yehia RM, ElMeligie MM, Hanafy AF. Effectiveness of high intensity laser therapy on pain, grip strength and median nerve conductivity in pregnant women with carpal tunnel syndrome: A randomized controlled trial. J Hand Ther. 2023 Jul-Sep;36(3):536-545. doi: 10.1016/j.jht.2022.03.005. Epub 2022 Jul 8.

  PMID: 35817691 BACKGROUND

• Yigit F, Ordahan B. Effects of high-intensity laser therapy on pain, functional status, hand grip strength, and median nerve cross-sectional area by ultrasonography in patients with carpal tunnel syndrome. Lasers Med Sci. 2023 Oct 31;38(1):248. doi: 10.1007/s10103-023-03913-z.

  PMID: 37906312 BACKGROUND

• Ezzati K, Laakso EL, Saberi A, Yousefzadeh Chabok S, Nasiri E, Bakhshayesh Eghbali B. A comparative study of the dose-dependent effects of low level and high intensity photobiomodulation (laser) therapy on pain and electrophysiological parameters in patients with carpal tunnel syndrome. Eur J Phys Rehabil Med. 2020 Dec;56(6):733-740. doi: 10.23736/S1973-9087.19.05835-0. Epub 2019 Nov 18.

  PMID: 31742366 BACKGROUND

Related Links

• Effectiveness of high intensity laser therapy on pain, grip strength and median nerve conductivity in pregnant women with carpal tunnel syndrome: A randomized controlled trial
• Effects of high-intensity laser therapy on pain, functional status, hand grip strength, and median nerve cross-sectional area by ultrasonography in patients with carpal tunnel syndrome
• A comparative study of the dose-dependent effects of low level and high intensity photobiomodulation (laser) therapy on pain and electrophysiological parameters in patients with carpal tunnel syndrome

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Ümit DÜNDAR, Profesor

  AFYONKARAHİSAR HEALTH SCİENCES UNİVERSITY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ümit DÜNDAR, Profesor

CONTACT

05337494526; umitftr@yahoo.com

Ramazan TUNCER, M.D

CONTACT

05060238608; ramazantuncer992@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: med.doctor

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

TU (2)