The Effectiveness of Low-Level Laser Therapy in the Treatment of Meralgia Paresthetica

March 4, 2026 updated by: Merve Sade Dağdeviren, Istanbul Training and Research Hospital

Patients diagnosed with meralgia paresthetica via electromyography (EMG), who present with neuropathic complaints on the lateral thigh to the Physical Medicine and Rehabilitation outpatient clinics of our hospital, will be included in the study after reviewing exclusion criteria. Patients will be randomized into two equal groups using a sealed-envelope system. The treatment group will receive low-level laser therapy (LLLT) combined with simultaneous transcutaneous electrical nerve stimulation (TENS), while the control group will receive placebo laser therapy combined with simultaneous TENS.

An LED gallium-aluminum-arsenide (Ga-Al-As) diode laser device with a power of 1.6 W and a wavelength of 808 nm will be used in the study. The treatment will consist of 10 sessions, applied over two weeks, five days per week.

Demographic data (age, gender, body mass index, and occupation) of all patients included in the study will be recorded. Pain and functional impairment will be evaluated using the VAS, SF-36, PSQI, and S-LANSS scales for all patients. VAS, SF-36, PSQI, and S-LANSS scores will be assessed at the end of the treatment and on the 30th day after treatment completion (6th-week after baseline). The effectiveness of low-level laser therapy will be investigated using statistical data analysis methods.

Low-level laser therapy will be applied perpendicularly, consistent with the lateral femoral cutaneous nerve projection, delivering a total of 4 J of energy over 12 minutes. TENS electrodes will be placed on the painful anterolateral thigh region in both groups. The stimulation pulse frequency will be set to 100 Hz, and the pulse width will be set to 100 ms. In the control group, sham laser will be applied using the same device and in the same manner; however, no laser beam will be emitted to the designated areas.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Not yet recruiting
        • Istanbul Training and Research Hospital
        • Contact:
      • Istanbul, Fatih, Turkey (Türkiye), 34098
        • Recruiting
        • Istanbul Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Patients aged 18 to 70 with neuropathic complaints in the anterolateral thigh, whose diagnosis has been confirmed by sensory conduction studies of the lateral femoral cutaneous nerve.

Exclusion Criteria: - Patients with diabetes mellitus

  • Patients with polyneuropathy
  • Patients with radicular pain
  • Patients receiving treatment for neuropathic pain
  • Patients who have received an injection to the lateral femoral cutaneous nerve within the last three months
  • Patients who have undergone physical therapy modalities for a diagnosis of meralgia paresthetica within the last three months
  • Patients with a history of pelvic surgery
  • Patients diagnosed with rheumatologic diseases
  • Pregnant women
  • Patients with active skin infections
  • Malignancy
  • Fibromyalgia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: LOW LEVER LASER THERAPY AND TENS
Low-level laser therapy will be applied perpendicularly at four different points, delivering a total of 4 J of energy over 12 minutes. TENS electrodes will be placed on the painful anterolateral thigh region
Other: Transcutaneous Electrical Nerve Stimulation (TENS)
TENS electrodes will be placed on the painful anterolateral thigh region in both groups. The stimulation pulse frequency will be set to 100 Hz, and the pulse width will be set to 100 ms.
Other: Low-Level Laser Therapy
Low-level laser therapy will be applied perpendicularly, consistent with the lateral femoral cutaneous nerve projection, delivering a total of 4 J of energy over 12 minutes.
Sham Comparator: Group 2: SHAM LASER AND TENS THERAPY
Sham laser will be applied using the same device and in the same manner; however, no laser beam will be emitted to the designated areas. TENS electrodes will be placed on the painful anterolateral thigh region
Other: Transcutaneous Electrical Nerve Stimulation (TENS)
TENS electrodes will be placed on the painful anterolateral thigh region in both groups. The stimulation pulse frequency will be set to 100 Hz, and the pulse width will be set to 100 ms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain will be assessed with Visual Analog Scale.
Time Frame: It will be evaluated at the baseline, at the end of treatment, and at the sixth-week follow-up.
Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.
It will be evaluated at the baseline, at the end of treatment, and at the sixth-week follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic pain will be assessed using the S-LANSS scale.
Time Frame: It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.
In the S-LANSS pain score, the patient evaluates the worst pain they experienced during the past week. The questions are answered with either 'yes' or 'no.' The total score ranges from 0 to 24. If the total score is twelve or higher, the pain is considered primarily neuropathic in nature.
It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.
General health status will be assessed with Short Form 36.
Time Frame: It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.
Short Form 36 (SF-36) is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
Time Frame: It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.

Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.

Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2026

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

June 5, 2026

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/02/2025;2011-KAEK-50;37

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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