The Efficacy of High-Power Laser Therapy in Meralgia Paresthetica

NCT07328360 | Recruiting

• 1 other identifier: AYK&ES&NS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meralgia Paresthetica

Keywords

Laser Therapy; Meralgia Paresthetica; Pain; Itching; discopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental Group: HPLT

EXPERIMENTAL

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; Other: Standard Conservative Care

Control Group: Sham Laser

SHAM COMPARATOR

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: Sham laser; Other: Standard Conservative Care

Interventions

High-power laser DEVICE

Operating Mode: Continuous wave Power Output: 10 Watts Energy Dose: A typical effective dose for deep nerves is "800 J per session"

Experimental Group: HPLT

Sham laser OTHER

The device will beep and display as if it is working.

Control Group: Sham Laser

Standard Conservative Care OTHER

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.

Control Group: Sham Laser; Experimental Group: HPLT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uşak University: lead
• Balikesir University: collaborator

Study Sites (1)

Usak University

Uşak, 64200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Femoral Neuropathy; Pain; Pruritus

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Study Officials

• Ali Y Karahan, Prof.

  University of Usak

  STUDY CHAIR

Central Study Contacts

Ali Y Karahan, Prof.

CONTACT

+9053869219134; ali.karahan@usak.edu.tr

Ender Salbas, Asst. Prof.

CONTACT

+905556698639; drendersalbas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor Blinding: The clinician performing the outcome assessments will be blinded to group allocation. Therapist blinding: The therapist applying the laser will not be blinded to the study protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Design: A prospective, randomized, assessor-blinded, two-arm parallel-group controlled trial.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 9, 2026
• Study Start: January 12, 2026
• Primary Completion: July 5, 2026
• Study Completion (Estimated): August 5, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)