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HILT for Meralgia Paresthetica

A

Ahram Canadian University

Status

Completed

Conditions

Meralgia Paresthetica
Lateral Femoral Cutaneous Nerve Entrapment

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05893732
012/004277

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

35 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

62 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Amal Fawzy, Ph.d; Mohamed M ElMeligie, Ph.d

Data sourced from clinicaltrials.gov

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