HILT for Meralgia Paresthetica: A Randomized Controlled Trial

Meralgia Paresthetica Clinical Trial

Official title:

Efficacy of High-Intensity Laser Therapy in the Management of Meralgia Paresthetica: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893732
• Other study ID #: 012/004277
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: May 2023
• Source: Ahram Canadian University
• Contact: Mohamed M ElMeligie, Ph.d
• Phone: +201064442032
• Email: mohamed.elmeligie[@]acu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 15, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Neuropathy
• Meralgia Paresthetica
• Nerve Compression Syndromes

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Secondary	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 measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Secondary	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 measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Secondary	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.	Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups