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

Sponsor
Necmettin Erbakan University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05678595
Collaborator
(none)
60
1
2
5.7
10.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: high-intensity laser therapy
  • Device: sham high-intensity laser therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Apr 25, 2023
Anticipated Study Completion Date :
May 25, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banu Ordahan Konya Turkey

Sponsors and Collaborators

  • Necmettin Erbakan University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Banu Ordahan, Clinical Professor, Necmettin Erbakan University
ClinicalTrials.gov Identifier:
NCT05678595
Other Study ID Numbers:
  • fatih yiğit
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
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
Keywords provided by Banu Ordahan, Clinical Professor, Necmettin Erbakan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2023