The Effect of High-intensity Laser Therapy in Patients With Carpal Tunnel Syndrome.

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: high-intensity laser therapy; Device: sham high-intensity laser therapy

• Registration Number: NCT05678595
• Lead Sponsor: Necmettin Erbakan University

Brief Summary

The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on pain, functional status, hand grip strength and median nerve cross-sectional area in ultrasonography in patients with carpal tunnel syndrome.

Detailed Description

Patients who are admitted and diagnosed with carpal tunnel syndrome based on anamnesis, physical examination and electromyography are included in the study.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-10
• Status Verified: 2023-06
• Primary Completion: 2023-06-23
• Study Completion: 2023-06-23
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Electrophysiologically mild or moderate CTS
2. Patients who are literate and able to understand verbal instructions in our

Exclusion Criteria

1. Diabetes
2. Systemic disorders that may affect treatment such as hypothyroidism, SLE, gout
3. History of polyneuropathy, cervical radiculopathy, brachial plexopathy
4. Injection for the carpal tunnel in the last 1 month
5. History of severe trauma, fracture, operation to both upper extremities at any time
6. Malignancy or history of malignancy
7. Renal failure
8. Peripheral or central nervous system diseases
9. Pregnancy
10. History of physical therapy program for the same hand wrist in the last months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham high-intensity laser therapy	high-intensity laser therapy	HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.
A hot laser derived from a Nd: YAG laser	sham high-intensity laser therapy	HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the hand wrist area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first five sessions consisted of a 100-second intermittent phase analgesic effect at 8 W and 8 J/cm2 for a total energy of 200 J. The following five sessions consisted of a continuous 11 minutes 6 second bio stimulating effect with a dosage of 3 W 80 J/cm2. Over the course of two weeks, ten treatment sessions of HILT will be given.
sham high-intensity laser therapy	sham high-intensity laser therapy	HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.
A hot laser derived from a Nd: YAG laser	high-intensity laser therapy	HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the hand wrist area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first five sessions consisted of a 100-second intermittent phase analgesic effect at 8 W and 8 J/cm2 for a total energy of 200 J. The following five sessions consisted of a continuous 11 minutes 6 second bio stimulating effect with a dosage of 3 W 80 J/cm2. Over the course of two weeks, ten treatment sessions of HILT will be given.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	Change from baseline in pain on the VAS at week 2 and week 12 [ Time Frame: Baseline-Week 2- Week 12 ]	Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain.

Secondary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Questionnaire	Change from baseline in pain and disability on the Boston Carpal Tunnel Questionnaire at week 2 and 12.	The Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. The Symptom Severity Scale (SSS) with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale (FSS) with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as difficult.
The cross-sectional area of the median nerve	Change from baseline in the cross-sectional area of the median nerve at week 2 and week 12.	The cross-sectional area of the median nerve will be measured by USG at the level of the pisiform bone (proximal carpal tunnel). While the patient is in a sitting position, the arm on the measuring side will be positioned semiflexed, elbow semiflexed, forearm supinated, fingers semi-flexed, and wrist on a flat surface.
Hand Grip Force Measurement Test	Baseline- week 2- week 12	A hydraulic hand dynamometer (Jamar) will be used in the measurements. Three measurements will be made with the elbow flexed and connected to the body, and the forearm in a neutral position. The measurements will be averaged in kg-f and recorded in the study form.

Trial Locations

Locations (1)

Banu Ordahan; 🇹🇷 Konya, Turkey