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.

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.

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.

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.

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

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.