HILT for Meralgia Paresthetica

NCT ID: NCT05893732

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-09-08

Brief Summary

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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

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Conditions

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Meralgia Paresthetica Lateral Femoral Cutaneous Nerve Entrapment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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High-Intensity Laser Therapy (HILT) Group

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

Group Type EXPERIMENTAL

High-Intensity Laser Therapy (HILT)

Intervention Type 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.

Sham High-Intensity Laser Therapy (Sham HILT) Group

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

Group Type SHAM_COMPARATOR

Sham High-Intensity Laser Therapy (Sham HILT)

Intervention Type 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.

Interventions

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High-Intensity Laser Therapy (HILT)

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

Sham High-Intensity Laser Therapy (Sham HILT)

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.

Intervention Type DEVICE

Other Intervention Names

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High power laser therapy

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahram Canadian University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed M ElMeligie, Ph.d

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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012/004277

Identifier Type: -

Identifier Source: org_study_id

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