Back to resultsHILT for Meralgia Paresthetica: A Randomized Controlled Trial
Primary Purpose
Meralgia Paresthetica, Lateral Femoral Cutaneous Nerve Entrapment
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High-Intensity Laser Therapy (HILT)
Sham High-Intensity Laser Therapy (Sham HILT)
Sponsored by
About this trial
This is an interventional treatment trial for Meralgia Paresthetica
Eligibility Criteria
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.
Sites / Locations
- Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
High-Intensity Laser Therapy (HILT) Group
Sham High-Intensity Laser Therapy (Sham HILT) Group
Arm Description
Participants in this group will receive High-Intensity Laser Therapy (HILT) treatment for Meralgia Paresthetica (MP).
Participants in this group will receive sham High-Intensity Laser Therapy (sham HILT) treatment for Meralgia Paresthetica (MP).
Outcomes
Primary Outcome Measures
Changes in Lateral Femoral Cutaneous Nerve Distal Latency
The primary outcome measure is 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.
Secondary Outcome Measures
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 in Functional Outcomes
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05893732
Brief Title
HILT for Meralgia Paresthetica: A Randomized Controlled Trial
Official Title
Efficacy of High-Intensity Laser Therapy in the Management of Meralgia Paresthetica: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meralgia Paresthetica, Lateral Femoral Cutaneous Nerve Entrapment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-Intensity Laser Therapy (HILT) Group
Arm Type
Experimental
Arm Description
Participants in this group will receive High-Intensity Laser Therapy (HILT) treatment for Meralgia Paresthetica (MP).
Arm Title
Sham High-Intensity Laser Therapy (Sham HILT) Group
Arm Type
Sham Comparator
Arm Description
Participants in this group will receive sham High-Intensity Laser Therapy (sham HILT) treatment for Meralgia Paresthetica (MP).
Intervention Type
Device
Intervention Name(s)
High-Intensity Laser Therapy (HILT)
Other Intervention Name(s)
High power laser therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham High-Intensity Laser Therapy (Sham HILT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Lateral Femoral Cutaneous Nerve Distal Latency
Description
The primary outcome measure is 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.
Time Frame
Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Secondary Outcome Measure Information:
Title
Changes in Pain Intensity
Description
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.
Time Frame
Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Title
Changes in Functional Outcomes
Description
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.
Time Frame
Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Title
Changes in Quality of Life
Description
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.
Time Frame
Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amal Fawzy, Ph.d
Email
dr.amalfawzy@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The researchers of this study are committed to promoting open science and collaboration among researchers. As part of this commitment, we will share de-identified individual participant data (IPD) with other qualified researchers, upon request and in accordance with applicable regulations and ethical guidelines. The dataset will not contain any personally identifiable information or sensitive data that could compromise the privacy and confidentiality of study participants.
IPD Sharing 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.
IPD Sharing 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
Learn more about this trial
HILT for Meralgia Paresthetica: A Randomized Controlled Trial
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