The Efficacy of High-Power Laser Therapy in Meralgia Paresthetica

The Efficacy of High-Power Laser Therapy as an Adjunct to Conservative Management in Patients With Meralgia Paresthetica: A Randomized, Assessor-Blinded, Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Meralgia Paresthetica
• Intervention / Treatment: Device: High-power laser; Other: Standard Conservative Care; Other: Sham laser

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ali Y Karahan, Prof.; Phone Number: +9053869219134; Email: ali.karahan@usak.edu.tr
• Study Contact Backup: Name: Ender Salbas, Asst. Prof.; Phone Number: +905556698639; Email: drendersalbas@gmail.com

Study Locations

• Turkey (Türkiye)
  • Uşak, Turkey (Türkiye), 64200
    • Recruiting
    • Uşak University
    • Contact: Ali Y Karahan, Prof; Phone Number: +905386921934; Email: ali.karahan@usak.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group: HPLT; Application Technique: Scanning technique. The laser probe will be moved slowly and continuously over the entire course of the LFCN (from just medial and inferior to the ASIS, distally along the thigh).	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: 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.
Sham Comparator: Control Group: Sham Laser; Identical procedure as Group 1, but with a sham laser applicator that emits no therapeutic energy. 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.; Other: Sham laser; The device will beep and display as if it is working.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PainDETECT	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.	Baseline, 3rd week, 3rd months

Collaborators and Investigators

• Sponsor: Uşak University
• Collaborators: Balikesir University
• Investigators: Study Chair: Ali Y Karahan, Prof., University of Usak

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): July 5, 2026
• Study Completion (Estimated): August 5, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 3, 2026
• First Posted (Estimated): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Laser Therapy; Itching; discopathy; Meralgia Paresthetica
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Skin Manifestations; Skin Diseases; Mononeuropathies; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Pain; Pruritus; Femoral Neuropathy
• Other Study ID Numbers: AYK&ES&NS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Authors plan to withhold individual participant data (IPD).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No