Usak University
Uşak, 64200, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07328360
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
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Uşak, 64200, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Operating Mode: Continuous wave Power Output: 10 Watts Energy Dose: A typical effective dose for deep nerves is "800 J per session"
The device will beep and display as if it is working.
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.
Time frame: Baseline, 3rd week, 3rd months
PainDETECT screening questionnaire: PainDETECT is a simple, easy to use screening questionnaire. The questionnaire consists of 9 items and is completed by the patient (no clinical examination is required). There are 7 weighted sensory descriptor items (never to very strongly) and 2 items relating to spatial and temporal pain characteristics. A total score of 19 or more is indicative of likely neuropathic pain.
Contact information is provided by the study sponsor or research team.
Ali Y Karahan, Prof.
CONTACT
Ender Salbas, Asst. Prof.
CONTACT
Uşak University
Other
The Efficacy of High-Power Laser Therapy as an Adjunct to Conservative Management in Patients With Meralgia Paresthetica: A Randomized, Assessor-Blinded, Controlled Trial
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