Back to resultsThe Effect of High-intensity Laser Therapy in Patients With Carpal Tunnel Syndrome.
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
high-intensity laser therapy
sham high-intensity laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring pain, High-intensity laser therapy, ultrasonography
Eligibility Criteria
Inclusion Criteria: Electrophysiologically mild or moderate CTS Patients who are literate and able to understand verbal instructions in our Exclusion Criteria: Diabetes Systemic disorders that may affect treatment such as hypothyroidism, SLE, gout History of polyneuropathy, cervical radiculopathy, brachial plexopathy Injection for the carpal tunnel in the last 1 month History of severe trauma, fracture, operation to both upper extremities at any time Malignancy or history of malignancy Renal failure Peripheral or central nervous system diseases Pregnancy History of physical therapy program for the same hand wrist in the last months.
Sites / Locations
- Banu Ordahan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
A hot laser derived from a Nd: YAG laser
sham high-intensity laser therapy
Arm Description
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.
HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS)
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05678595
First Posted
January 2, 2023
Last Updated
June 23, 2023
Sponsor
Necmettin Erbakan University
1. Study Identification
Unique Protocol Identification Number
NCT05678595
Brief Title
The Effect of High-intensity Laser Therapy in Patients With Carpal Tunnel Syndrome.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
June 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
Detailed Description
Patients who are admitted and diagnosed with carpal tunnel syndrome based on anamnesis, physical examination and electromyography are included in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
pain, High-intensity laser therapy, ultrasonography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A hot laser derived from a Nd: YAG laser
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sham high-intensity laser therapy
Arm Type
Sham Comparator
Arm Description
HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.
Intervention Type
Device
Intervention Name(s)
high-intensity laser therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham high-intensity laser therapy
Intervention Description
HILT is administered as a placebo for two weeks, 5 sessions a week, for a total of 10 sessions.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain.
Time Frame
Change from baseline in pain on the VAS at week 2 and week 12 [ Time Frame: Baseline-Week 2- Week 12 ]
Secondary Outcome Measure Information:
Title
Boston Carpal Tunnel Questionnaire
Description
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.
Time Frame
Change from baseline in pain and disability on the Boston Carpal Tunnel Questionnaire at week 2 and 12.
Title
Hand Grip Force Measurement Test
Description
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.
Time Frame
Baseline- week 2- week 12
Title
The cross-sectional area of the median nerve
Description
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.
Time Frame
Change from baseline in the cross-sectional area of the median nerve at week 2 and week 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Electrophysiologically mild or moderate CTS
Patients who are literate and able to understand verbal instructions in our
Exclusion Criteria:
Diabetes
Systemic disorders that may affect treatment such as hypothyroidism, SLE, gout
History of polyneuropathy, cervical radiculopathy, brachial plexopathy
Injection for the carpal tunnel in the last 1 month
History of severe trauma, fracture, operation to both upper extremities at any time
Malignancy or history of malignancy
Renal failure
Peripheral or central nervous system diseases
Pregnancy
History of physical therapy program for the same hand wrist in the last months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BANU ORDAHAN
Organizational Affiliation
Meram Medical School, Necmettin Erbakan University, Konya, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banu Ordahan
City
Konya
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effect of High-intensity Laser Therapy in Patients With Carpal Tunnel Syndrome.
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