Low-level laser combined with TENS for meralgia paresthetica
The Effectiveness of Low-Level Laser Therapy in the Treatment of Meralgia Paresthetica
This test will try low-level laser therapy plus TENS versus placebo laser plus TENS to reduce pain and numbness in adults with EMG-confirmed meralgia paresthetica.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Istanbul Training and Research Hospital Government |
| Locations | 2 sites (Istanbul, Fatih and 1 other locations) |
| Trial ID | NCT07335822 on ClinicalTrials.gov |
What this trial studies
Adults with EMG-confirmed meralgia paresthetica are randomized to receive either active low-level laser therapy (Ga-Al-As 808 nm, 1.6 W) combined with simultaneous TENS or a placebo laser combined with TENS. Treatment consists of 10 outpatient sessions delivered over two weeks (five days per week) at a single center. Demographic data will be recorded and pain and functional impairment will be measured before and after the intervention to compare groups. The randomized, placebo-controlled design aims to isolate the specific effect of the laser when given alongside TENS.
Who should consider this trial
Good fit: Adults aged 18–70 with neuropathic symptoms on the anterolateral thigh and sensory conduction study confirmation of lateral femoral cutaneous nerve entrapment who meet eligibility criteria.
Not a fit: Patients with diabetes, polyneuropathy, radicular pain, ongoing neuropathic pain treatment, recent lateral femoral cutaneous nerve injection or physical therapy, prior pelvic surgery, rheumatologic disease, active skin infection, malignancy, fibromyalgia, or pregnancy are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this noninvasive combination could reduce lateral thigh neuropathic pain and improve daily function without surgery or systemic drugs.
How similar studies have performed: Prior small studies of low-level laser therapy and TENS for peripheral neuropathic pain have shown mixed results, and the specific combination for meralgia paresthetica is relatively novel and not yet well established.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Istanbul, Fatih and 1 other locations
- Istanbul Training and Research Hospital — Istanbul, Fatih, Turkey (Türkiye) (Not_yet_recruiting)
- Istanbul training and research hospital — Istanbul, Fatih, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Merve Sade Dağdeviren
- Email: mervesade4@gmail.com
- Phone: +902124596000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.