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

NCT ID: NCT07294157

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-09-15

Brief Summary

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The aim of this study is to compare the effectiveness of rest splints and high-intensity laser therapy added to physical therapy programs for patients with carpal tunnel syndrome in terms of pain, function, nerve conduction studies, and grip strength.

Detailed Description

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Carpal tunnel syndrome (CTS) is the most common entrapment nerve compression, causing numbness and tingling in the hand, atrophy and muscle weakness in advanced stages. Any condition that increases the volume of the carpal tunnel and narrows the diameter of the tunnel can increase the compression of the median nerve under the transverse carpal ligament and cause symptoms. The use of a wrist splint or wrist brace is a common method of non-surgical treatment of carpal tunnel syndrome. The wrist splint is designed to allow rotation and supination, while eliminating the possibility of extension, flexion and radial-ulnar deviation.High-intensity laser therapy is used to provide symptomatic relief and reduce pain-related inflammation. The soothing effect of the laser is remarkable, especially in acute cases, but in the case of chronic disorders, the pain may be aggravated after the first treatments and is continued only if it decreases.

This study was designed as a prospective randomised controlled trial. Participants were randomised into 3 groups. The 1st group will receive wrist range of motion exercises, isometric strengthening, intrinsic muscle strengthening, wrist stretching, desensitization exercises, tendon sliding exercises, median nerve sliding exercises, wrist flexion and extension exercises, grip strengthening exercises and resting splint application for 6 weeks, 5 days a week, 30 sessions in total. The 2nd group (HILT group) will be given high intensity laser therapy 5 days a week for 6 weeks (30 sessions in total) in addition to the physical therapy program. The 3rd group will be the sham HILT group and physical therapy exercises will be applied like the other groups.

Conditions

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Carpal Tunnel Syndrome (CTS)

Keywords

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Carpal Tunnel Syndrome Physical Therapy Modalities Electromyography veya Nerve Conduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: 1. Group (rest splint group)

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.

Group Type EXPERIMENTAL

Rest splint group

Intervention Type 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: Group 2 (high-intensity laser therapy (HILT))

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.

Group Type EXPERIMENTAL

high-intensity laser therapy (HILT)

Intervention Type 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.

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

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.

Group Type SHAM_COMPARATOR

sham high-intensity laser therapy (HILT)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Afyonkarahisar Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Ramazan Tuncer

med.doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ümit DÜNDAR, Profesor

Role: PRINCIPAL_INVESTIGATOR

AFYONKARAHİSAR HEALTH SCİENCES UNİVERSITY

Locations

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Afyonkarahisar Health Science University

Afyonkarahisar, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Ümit DÜNDAR, Profesor

Role: CONTACT

Phone: 05337494526

Email: [email protected]

Ramazan TUNCER, M.D

Role: CONTACT

Phone: 05060238608

Email: [email protected]

Facility Contacts

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Ramazan TUNCER, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 35817691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37906312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31742366 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/35817691/

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

https://pubmed.ncbi.nlm.nih.gov/37906312/

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

https://pubmed.ncbi.nlm.nih.gov/31742366/

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

Other Identifiers

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2024-KAEK-09

Identifier Type: -

Identifier Source: org_study_id