HILT for Meralgia Paresthetica

NCT05893732 | Completed

• 1 other identifier: 012/004277
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Meralgia Paresthetica; Lateral Femoral Cutaneous Nerve Entrapment

Outcome Measures

Primary Outcomes (1)

• Changes in Pain Intensity

  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.

  Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups

Secondary Outcomes (3)

• 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

• Changes in Functional Outcomes

  Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups

• Changes in Quality of Life

  Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups

Study Arms (2)

High-Intensity Laser Therapy (HILT) Group

EXPERIMENTAL

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

Device: High-Intensity Laser Therapy (HILT)

Sham High-Intensity Laser Therapy (Sham HILT) Group

SHAM COMPARATOR

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

Device: Sham High-Intensity Laser Therapy (Sham HILT)

Interventions

High-Intensity Laser Therapy (HILT) DEVICE

Participants will undergo HILT treatment using a diode laser device (wavelength: 1064 nm; power: 12 W; peak power: 50 W; energy density: 600 J/cm²; spot size: 1 cm²; pulse duration: 200 μs; pulse frequency: 10 Hz) applied in continuous mode. The laser probe will make contact with the skin over the LFCN entrapment site at three specific points: (a) the inguinal ligament, (b) the point of maximum tenderness along the nerve pathway, and (c) the mid-point between the ASIS and the lateral border of the patella. Each point will be treated for 1 minute and 40 seconds, totaling a 5-minute session. Participants will undergo 12 sessions in total, with three sessions per week for four weeks.

Also known as: High power laser therapy

High-Intensity Laser Therapy (HILT) Group

Sham High-Intensity Laser Therapy (Sham HILT) DEVICE

Participants will undergo sham HILT treatment using an identical laser device with no active laser output, following the same treatment protocol as the HILT group. The laser probe will make contact with the skin over the LFCN entrapment site at the same three specific points as the HILT group. Each point will be treated for 1 minute and 40 seconds, totaling a 5-minute session. Participants will undergo 12 sessions in total, with three sessions per week for four weeks.

Sham High-Intensity Laser Therapy (Sham HILT) Group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Location

MeSH Terms

Conditions

Femoral Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Mohamed M ElMeligie, Ph.d

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In this study, both the participants and the outcomes assessor will be blinded. Participants will be unaware of whether they are receiving active HILT or sham HILT, while the outcomes assessor will not know the treatment allocation while assessing the outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: June 1, 2023
• Primary Completion: September 8, 2024
• Study Completion: September 8, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified IPD will be available for sharing with other researchers starting six months after the publication of the primary study results and will remain accessible for a period of five years.
• Access Criteria: Researchers interested in accessing the IPD must submit a written request to the principal investigator, detailing the information required. Upon approval of a request, the researchers will be required to sign a data sharing agreement that outlines the terms and conditions of IPD access, including provisions on data use, confidentiality, security, and reporting of research results. via email mohamed.elmeligie@acu.edu.eg

Locations

EG (1)