The Efficacy of High-Power Laser Therapy in Meralgia Paresthetica
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-power laser, Sham laser, Standard Conservative Care.
- Who it may be relevant to
- Registry conditions: Meralgia Paresthetica. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy of High-Power Laser Therapy as an Adjunct to Conservative Management in Patients With Meralgia Paresthetica: A Randomized, Assessor-Blinded, Controlled Trial
Overview
The management of MP typically follows a conservative pathway, encompassing patient education, lifestyle modifications (e.g., avoidance of tight garments, weight loss), pharmacotherapy (such as neuropathic pain agents or corticosteroid injections), and physical therapy. However, evidence supporting the efficacy of these interventions is largely anecdotal or derived from low-quality studies, and a substantial proportion of patients experience persistent symptoms refractory to standard care. Therefore, the primary objective of this randomized, sham-controlled, assessor-blinded study is to investigate the efficacy of HPLT as an adjunct to standard conservative care on pain intensity, sensory symptoms, and functional capacity in patients with chronic Meralgia Paresthetica. The investigators hypothesize that patients receiving active HPLT will demonstrate significantly greater improvements in these outcomes compared to those receiving a sham laser procedure
Detailed description
Meralgia Paresthetica (MP) is a mononeuropathy characterized by dysesthetic sensations-including burning pain, tingling, and numbness-in the lateral aspect of the thigh. This condition results from the entrapment or compression of the lateral femoral cutaneous nerve (LFCN) as it passes beneath or through the inguinal ligament near the anterior superior iliac spine (ASIS). Common etiological factors include obesity, pregnancy, tight clothing, rapid weight changes, and direct trauma, which increase mechanical stress on the nerve. Despite its relatively high prevalence, MP often remains underdiagnosed and can lead to significant chronic discomfort, functional limitations, and reduced quality of life.
The management of MP typically follows a conservative pathway, encompassing patient education, lifestyle modifications (e.g., avoidance of tight garments, weight loss), pharmacotherapy (such as neuropathic pain agents or corticosteroid injections), and physical therapy. However, evidence supporting the efficacy of these interventions is largely anecdotal or derived from low-quality studies, and a substantial proportion of patients experience persistent symptoms refractory to standard care. For those with intractable pain, invasive procedures like surgical decompression or neurectomy may be considered, though these carry inherent risks of surgical complications and permanent sensory loss. Consequently, there is a pressing need to identify and evaluate novel, effective, and non-invasive therapeutic modalities for MP.
High-Power Laser Therapy (HPLT), also known as high-intensity laser therapy, represents an advanced non-thermal phototherapeutic modality that has gained increasing attention in musculoskeletal and neuropathic pain management. Operating at power outputs typically ranging from 1 to 15 Watts, HPLT utilizes wavelengths (often 980 nm or 1064 nm) that allow for deep tissue penetration. Unlike its low-level counterpart (LLLT), which primarily exerts photobiomodulatory effects, HPLT delivers significant photothermal energy. Its proposed mechanisms of action are multifactorial, including deep tissue analgesia, reduction of inflammation, enhanced microcirculation, and accelerated nerve regeneration. These properties make HPLT a theoretically ideal intervention for entrapment neuropathies like MP, where reducing local inflammation and mechanical stress around the nerve is a primary treatment goal.
Although the application of LLLT for various neuropathies has been explored, the body of literature investigating the specific role of HPLT in compressive mononeuropathies, particularly MP, remains in its infancy. A limited number of studies and case reports have suggested promising analgesic and functional outcomes with HPLT in similar conditions, but robust, randomized controlled trials are lacking.
Therefore, the primary objective of this randomized, sham-controlled, assessor-blinded study is to investigate the efficacy of HPLT as an adjunct to standard conservative care on pain intensity, sensory symptoms, and functional capacity in patients with chronic Meralgia Paresthetica. The investigators hypothesize that patients receiving active HPLT will demonstrate significantly greater improvements in these outcomes compared to those receiving a sham laser procedure.
Interventions
- Device High-power laser
Operating Mode: Continuous wave Power Output: 10 Watts Energy Dose: A typical effective dose for deep nerves is "800 J per session" - Other Sham laser
The device will beep and display as if it is working. - Other Standard Conservative Care
Education: Advice on avoiding tight belts/trousers, weight loss if applicable, and posture modification. -Home Exercise Program: Stretching exercises for the hip flexors (iliopsoas, rectus femoris) and tensor fasciae latae (TFL) to reduce tension on the inguinal ligament.
Primary outcome measures
- PainDETECT [Time frame: Baseline, 3rd week, 3rd months]
Eligibility criteria
Inclusion criteria
- Adults aged 18-65 years.
- Clinical diagnosis of MP (based on history: burning pain, tingling, numbness in the lateral thigh; tenderness over the inguinal ligament near the anterior superior iliac spine (ASIS); and a positive pelvic compression test or Tinel's sign over the lateral femoral cutaneous nerve (LFCN)).
- Symptoms persistent for at least 3 months (chronic).
- A baseline pain intensity of ≥4 on the Numeric Rating Scale (NRS).
Exclusion criteria
- Secondary MP (e.g., due to pelvic surgery, trauma, or tumor mass effect confirmed by imaging).
- Significant lumbar radiculopathy (L1-L2).
- Coagulopathy, use of anticoagulants.
- Pregnancy.
- Skin disease or infection in the treatment area.
- Presence of a cardiac pacemaker.
- Severe cognitive impairment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Usak University — Uşak
Identifiers
NCT: NCT07328360 · AYK&ES&NS