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RecruitingNCT07328360Updated Jan 13, 2026

The Efficacy of High-Power Laser Therapy in Meralgia Paresthetica

An interventional study of High-power laser and Sham laser in Meralgia Paresthetica, sponsored by Uşak University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Uşak University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jan 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Meralgia Paresthetica

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Keywords

  • Laser Therapy
  • Meralgia Paresthetica
  • Pain
  • Itching
  • discopathy
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 50 is below the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Uşak University is the lead sponsor of 80 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • 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 · Other: Standard Conservative Care

  • 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: Sham laser · Other: Standard Conservative Care

Interventions

  • DeviceHigh-power laser

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

  • OtherSham laser

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

  • OtherStandard 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.

06

What researchers measure

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.

    Time frame: Baseline, 3rd week, 3rd months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Authors plan to withhold individual participant data (IPD).

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07328360
Lead sponsor
Uşak University
Collaborators
Balikesir University
Responsible party
Ali Yavuz Karahan (Professor, Uşak University) — Principal investigator
First posted
Jan 9, 2026
Start date
Jan 12, 2026
Primary completion
Jul 5, 2026 (estimated)
Completion
Aug 5, 2026 (estimated)
Last update
Jan 13, 2026

Study contacts

Ali Y Karahan, Prof.
Contact
ali.karahan@usak.edu.tr
+9053869219134
Ender Salbas, Asst. Prof.
Contact
drendersalbas@gmail.com
+905556698639
Ali Y Karahan, Prof.
study chair · University of Usak

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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