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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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
• 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.
• 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.

Primary outcome measures

• Visual Analog Scale (VAS): [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]

Secondary outcome measures (12)

• Boston Carpal Tunnel Questionnaire: [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]
• LANSS neuropathic pain assessment scale [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]
• Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]
• Quick DASH Questionnaire [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]
• Median nerve distal motor latency [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]
• Median nerve compound muscle action potential amplitude (CMAP) [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]
• Motor nerve conduction velocity [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]
• Second finger sensory nerve action potential amplitude [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]
• Median nerve distal sensory latency [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]
• )Sensory nerve conduction velocity [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]
• Grip strength [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]
• Pinchmeter [Time frame: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 2 centers

• Afyonkarahisar Health Science University — Afyonkarahisar
• Afyonkarahisar Health Sciences Unıversity — Afyonkarahisar

Publications

• 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
• 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
• 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

Identifiers

NCT: NCT07294157 · 2024-KAEK-09

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗