Clinical trial NCT05893732: HILT for Meralgia Paresthetica
Official title: Efficacy of High-Intensity Laser Therapy in the Management of Meralgia Paresthetica: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meralgia Paresthetica
Lateral Femoral Cutaneous Nerve Entrapment
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 62
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in Pain Intensity
timeFrame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Secondary outcomes:
measure: Changes in Lateral Femoral Cutaneous Nerve Distal Latency
timeFrame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
measure: Changes in Functional Outcomes
timeFrame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
measure: Changes in Quality of Life
timeFrame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Cairo University
name: Mohamed M ElMeligie, Ph.d
role: PRINCIPAL_INVESTIGATOR
References: