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

Istanbul Training and Research Hospital

Status: Not yet enrolling

Conditions: Meralgia Paresthetica; Lateral Femoral Cutaneous Nerve Entrapment

Treatments: Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Low-Level Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07335822

21/02/2025 2011-KAEK-50;37;

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Group 1: LOW LEVER LASER THERAPY AND TENS

Active Comparator group

Description:

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

Treatment:

Other: Low-Level Laser Therapy

Other: Transcutaneous Electrical Nerve Stimulation (TENS)

Group 2: SHAM LASER AND TENS THERAPY

Sham Comparator group

Description:

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

Treatment:

Other: Transcutaneous Electrical Nerve Stimulation (TENS)