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

NCT07335822 | Recruiting

• 1 other identifier: 21/02/2025;2011-KAEK-50;37
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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

Lateral Femoral Cutaneous Nerve Entrapment; Meralgia Paresthetica

Keywords

Meralgia Paresthetica; Lateral Femoral Cutaneous Nerve; Entrapment neuropathy; Low-Level Laser Therapy; thigh pain

Outcome Measures

Primary Outcomes (1)

• Pain will be assessed with Visual Analog Scale.

  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 Outcomes (3)

• Neuropathic pain will be assessed using the S-LANSS scale.

  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.

  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).

  It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.

Study Arms (2)

Group 1: LOW LEVER LASER THERAPY AND TENS

ACTIVE COMPARATOR

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); Other: Low-Level Laser Therapy

Group 2: SHAM LASER AND TENS THERAPY

SHAM COMPARATOR

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)

Interventions

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.

Group 1: LOW LEVER LASER THERAPY AND TENS; Group 2: SHAM LASER AND TENS THERAPY

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.

Group 1: LOW LEVER LASER THERAPY AND TENS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (2)

Istanbul Training and Research Hospital

Istanbul, Fatih, 34093, Turkey (Türkiye)

NOT YET RECRUITING

Istanbul training and research hospital

Istanbul, Fatih, 34098, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Femoral Neuropathy; Charcot-Marie-Tooth Disease

Interventions

Transcutaneous Electric Nerve Stimulation; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Laser Therapy; Phototherapy

Central Study Contacts

Merve Sade Dağdeviren

CONTACT

+902124596000; mervesade4@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients in the first group will receive low-level laser therapy, while patients in the second group will receive sham low-level laser therapy. Participants will not be informed about which group they are in. In addition, the outcome assessors will also conduct their assessments blinded to the groups to which the patients belong.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Participants will be randomly divided into two groups; the first group will receive low-level laser therapy and TENS, while the second group will receive sham laser and TENS therapy.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: January 13, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

TU (2)