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

NCT05678595 | Completed

• 1 other identifier: fatih yiğit
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

pain; High-intensity laser therapy; ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Boston Carpal Tunnel Questionnaire

  Change from baseline in pain and disability on the Boston Carpal Tunnel Questionnaire at week 2 and 12.

• Hand Grip Force Measurement Test

  Baseline- week 2- week 12

• 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.

Study Arms (2)

A hot laser derived from a Nd: YAG laser

ACTIVE COMPARATOR

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; Device: sham high-intensity laser therapy

sham high-intensity laser therapy

SHAM COMPARATOR

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

Device: high-intensity laser therapy; Device: sham high-intensity laser therapy

Interventions

high-intensity laser therapy 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.

A hot laser derived from a Nd: YAG laser; sham high-intensity laser therapy

sham high-intensity laser therapy DEVICE

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

A hot laser derived from a Nd: YAG laser; sham high-intensity laser therapy

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Electrophysiologically mild or moderate CTS
• Patients who are literate and able to understand verbal instructions in our

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Banu Ordahan

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• BANU ORDAHAN

  Meram Medical School, Necmettin Erbakan University, Konya, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 10, 2023
• Study Start: December 1, 2022
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

TU (1)