HILT for Meralgia Paresthetica

Not Applicable

Completed

• Conditions: Meralgia Paresthetica; Lateral Femoral Cutaneous Nerve Entrapment
• Interventions: Device: High-Intensity Laser Therapy (HILT); Device: Sham High-Intensity Laser Therapy (Sham HILT)

• Registration Number: NCT05893732
• Lead Sponsor: Ahram Canadian University

Brief Summary

This randomized controlled trial aims to investigate the efficacy of High-Intensity Laser Therapy (HILT) in the management of Meralgia Paresthetica (MP), a peripheral neuropathy causing pain, numbness, and tingling in the thigh region. Participants with MP will be randomly allocated to either the HILT or sham HILT (control) group. The study will evaluate the effects of HILT on pain intensity, functional outcomes, and quality of life. Findings from this trial will provide insights into the potential benefits of HILT as a non-invasive and safe treatment option for patients with MP.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Study Start: 2023-06-01
• Study First Posted: 2023-06-08
• Primary Completion: 2024-09-08
• Study Completion: 2024-09-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Diagnosis of Meralgia Paresthetica, confirmed by a neurologist or a specialist in neuromuscular disorders, based on clinical signs and symptoms, and supported by nerve conduction studies.
• Presence of pain, numbness, or tingling in the anterolateral thigh for at least three months.
• Aged between 35 and 55 years.
• Willing and able to provide informed consent.
• Able to comply with the study protocol and attend all treatment sessions and follow-up assessments.

Exclusion Criteria

• Previous surgical treatment for Meralgia Paresthetica.
• Concomitant lower back or hip pain due to other causes, such as lumbar radiculopathy, hip joint pathology, or trochanteric bursitis.
• Presence of other neuromuscular or nerve compression disorders such as diabetic neuropathy
• Significant trauma or surgery to the affected thigh or lumbar spine within the past six months.
• Pregnancy or planning to become pregnant during the study period.
• Known contraindications to High-Intensity Laser Therapy, such as active skin infection, malignancy, or photosensitivity disorders.
• Current use of anticoagulant medications or immunosuppressive therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-Intensity Laser Therapy (HILT) Group	High-Intensity Laser Therapy (HILT)	Participants in this group will receive High-Intensity Laser Therapy (HILT) treatment for Meralgia Paresthetica (MP).
Sham High-Intensity Laser Therapy (Sham HILT) Group	Sham High-Intensity Laser Therapy (Sham HILT)	Participants in this group will receive sham High-Intensity Laser Therapy (sham HILT) treatment for Meralgia Paresthetica (MP).

Primary Outcome Measures

Name	Time	Method
Changes in Pain Intensity	Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups	The secondary outcome measure is the change in pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a self-reported scale ranging from 0 (no pain) to 10 (worst pain imaginable). A reduction in NPRS scores indicates a decrease in pain intensity.

Secondary Outcome Measures

Name	Time	Method
Changes in Lateral Femoral Cutaneous Nerve Distal Latency	Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups	the change in distal latency of the lateral femoral cutaneous nerve (LFCN), assessed using nerve conduction studies. The distal latency represents the time it takes for an electrical impulse to travel along the nerve to the recording electrode. Reduced distal latency indicates improved nerve conduction and function.
Changes in Functional Outcomes	Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups	The secondary outcome measure is the change in functional outcomes, assessed using the Roland-Morris Disability Questionnaire (RMDQ), a self-reported questionnaire measuring the level of disability due to lower back and leg pain. Lower RMDQ scores indicate better functional outcomes and less disability.
Changes in Quality of Life	Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups	The secondary outcome measure is the change in quality of life, assessed using the Short Form-36 Health Survey (SF-36), a self-reported questionnaire evaluating overall health and well-being across eight domains. Higher SF-36 scores indicate better quality of life.

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt