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Completed

NCT Number: NCT05678595

The Effect of High-intensity Laser Therapy 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.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banu Ordahan

Konya, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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