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

Carpal Tunnel Syndrome Clinical Trial

Official title:

The Effect of High-intensity Laser Therapy on Pain, Functional Status, Hand Grip Strength and Median Nerve Cross-sectional Area in Ultrasonography in Patients With Carpal Tunnel Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05678595
• Other study ID #: fatih yigit
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 23, 2023

Study information

• Verified date: June 2023
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• 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
HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.

Locations

Country	Name	City	State
Turkey	Banu Ordahan	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain.	Change from baseline in pain on the VAS at week 2 and week 12 [ Time Frame: Baseline-Week 2- Week 12 ]
Secondary	Boston Carpal Tunnel Questionnaire	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.	Change from baseline in pain and disability on the Boston Carpal Tunnel Questionnaire at week 2 and 12.
Secondary	Hand Grip Force Measurement Test	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.	Baseline- week 2- week 12
Secondary	The cross-sectional area of the median nerve	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.	Change from baseline in the cross-sectional area of the median nerve at week 2 and week 12.