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

NCT07335822 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-03-05

No results posted yet for this study

Summary

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.

Conditions

  • Meralgia Paresthetica
  • Lateral Femoral Cutaneous Nerve Entrapment

Interventions

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.

Sponsors & Collaborators

  • Istanbul Training and Research Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-02
Primary Completion
2026-06-05
Completion
2026-06-05

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07335822 on ClinicalTrials.gov