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

NCT ID: NCT05678595

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-06-23

Brief Summary

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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

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

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

high-intensity laser therapy

Intervention Type DEVICE

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

Intervention Type DEVICE

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

sham high-intensity laser therapy

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

Group Type SHAM_COMPARATOR

high-intensity laser therapy

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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Banu Ordahan

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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BANU ORDAHAN

Role: PRINCIPAL_INVESTIGATOR

Meram Medical School, Necmettin Erbakan University, Konya, Turkey

Locations

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Banu Ordahan

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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fatih yiğit

Identifier Type: -

Identifier Source: org_study_id

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