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Completed

NCT Number: NCT07335822

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

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.

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Key information

Conditions

Meralgia Paresthetica Charcot-Marie-Tooth Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Femoral Neuropathy Genetic Diseases, Inborn Hereditary Sensory and Motor Neuropathy Heredodegenerative Disorders, Nervous System Lateral Femoral Cutaneous Nerve Entrapment Mononeuropathies Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Training and Research Hospital, Istanbul, Fatih, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation (TENS)

Other

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.

Low-level laser therapy

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jul 8, 2026

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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