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

June 23, 2023 updated by: Banu Ordahan, Necmettin Erbakan University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Banu Ordahan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A hot laser derived from a Nd: YAG laser
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.
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.
Device: sham high-intensity laser therapy
HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.
Sham Comparator: sham high-intensity laser therapy
HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.
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.
Device: sham high-intensity laser therapy
HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: 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.
Change from baseline in pain on the VAS at week 2 and week 12 [ Time Frame: Baseline-Week 2- Week 12 ]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Carpal Tunnel Questionnaire
Time Frame: 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.
Change from baseline in pain and disability on the Boston Carpal Tunnel Questionnaire at week 2 and 12.
Hand Grip Force Measurement Test
Time Frame: 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.
Baseline- week 2- week 12
The cross-sectional area of the median nerve
Time Frame: 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.
Change from baseline in the cross-sectional area of the median nerve at week 2 and week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Investigators

  • Principal Investigator: BANU ORDAHAN, Meram Medical School, Necmettin Erbakan University, Konya, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

June 23, 2023

Study Completion (Actual)

June 23, 2023

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fatih yiğit

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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