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NCT Number: NCT05893732

HILT for Meralgia Paresthetica

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.

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Key information

Conditions

Meralgia Paresthetica Femoral Neuropathy Lateral Femoral Cutaneous Nerve Entrapment Mononeuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-intensity laser therapy (HILT)

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.

Other names: High power laser therapy

Sham High-Intensity Laser Therapy (Sham HILT)

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.

Primary outcomes

  1. Changes in Pain Intensity

    Time frame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups

    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.

Secondary outcomes

  1. Changes in Lateral Femoral Cutaneous Nerve Distal Latency

    Time frame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups

    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.

  2. Changes in Functional Outcomes

    Time frame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups

    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.

  3. Changes in Quality of Life

    Time frame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups

    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.

Sponsors and collaborators

Lead sponsor

Ahram Canadian University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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