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Идёт набор NCT07328360

The Efficacy of High-Power Laser Therapy in Meralgia Paresthetica

Без фазы С лечением Meralgia Paresthetica

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: High-power laser, Sham laser, Standard Conservative Care.
Кому может быть актуально
Состояния в реестре: Meralgia Paresthetica. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Efficacy of High-Power Laser Therapy as an Adjunct to Conservative Management in Patients With Meralgia Paresthetica: A Randomized, Assessor-Blinded, Controlled Trial

Обзор

The management of MP typically follows a conservative pathway, encompassing patient education, lifestyle modifications (e.g., avoidance of tight garments, weight loss), pharmacotherapy (such as neuropathic pain agents or corticosteroid injections), and physical therapy. However, evidence supporting the efficacy of these interventions is largely anecdotal or derived from low-quality studies, and a substantial proportion of patients experience persistent symptoms refractory to standard care. Therefore, the primary objective of this randomized, sham-controlled, assessor-blinded study is to investigate the efficacy of HPLT as an adjunct to standard conservative care on pain intensity, sensory symptoms, and functional capacity in patients with chronic Meralgia Paresthetica. The investigators hypothesize that patients receiving active HPLT will demonstrate significantly greater improvements in these outcomes compared to those receiving a sham laser procedure

Подробное описание

Meralgia Paresthetica (MP) is a mononeuropathy characterized by dysesthetic sensations-including burning pain, tingling, and numbness-in the lateral aspect of the thigh. This condition results from the entrapment or compression of the lateral femoral cutaneous nerve (LFCN) as it passes beneath or through the inguinal ligament near the anterior superior iliac spine (ASIS). Common etiological factors include obesity, pregnancy, tight clothing, rapid weight changes, and direct trauma, which increase mechanical stress on the nerve. Despite its relatively high prevalence, MP often remains underdiagnosed and can lead to significant chronic discomfort, functional limitations, and reduced quality of life.

The management of MP typically follows a conservative pathway, encompassing patient education, lifestyle modifications (e.g., avoidance of tight garments, weight loss), pharmacotherapy (such as neuropathic pain agents or corticosteroid injections), and physical therapy. However, evidence supporting the efficacy of these interventions is largely anecdotal or derived from low-quality studies, and a substantial proportion of patients experience persistent symptoms refractory to standard care. For those with intractable pain, invasive procedures like surgical decompression or neurectomy may be considered, though these carry inherent risks of surgical complications and permanent sensory loss. Consequently, there is a pressing need to identify and evaluate novel, effective, and non-invasive therapeutic modalities for MP.

High-Power Laser Therapy (HPLT), also known as high-intensity laser therapy, represents an advanced non-thermal phototherapeutic modality that has gained increasing attention in musculoskeletal and neuropathic pain management. Operating at power outputs typically ranging from 1 to 15 Watts, HPLT utilizes wavelengths (often 980 nm or 1064 nm) that allow for deep tissue penetration. Unlike its low-level counterpart (LLLT), which primarily exerts photobiomodulatory effects, HPLT delivers significant photothermal energy. Its proposed mechanisms of action are multifactorial, including deep tissue analgesia, reduction of inflammation, enhanced microcirculation, and accelerated nerve regeneration. These properties make HPLT a theoretically ideal intervention for entrapment neuropathies like MP, where reducing local inflammation and mechanical stress around the nerve is a primary treatment goal.

Although the application of LLLT for various neuropathies has been explored, the body of literature investigating the specific role of HPLT in compressive mononeuropathies, particularly MP, remains in its infancy. A limited number of studies and case reports have suggested promising analgesic and functional outcomes with HPLT in similar conditions, but robust, randomized controlled trials are lacking.

Therefore, the primary objective of this randomized, sham-controlled, assessor-blinded study is to investigate the efficacy of HPLT as an adjunct to standard conservative care on pain intensity, sensory symptoms, and functional capacity in patients with chronic Meralgia Paresthetica. The investigators hypothesize that patients receiving active HPLT will demonstrate significantly greater improvements in these outcomes compared to those receiving a sham laser procedure.

Вмешательства

  • Устройство High-power laser
    Operating Mode: Continuous wave Power Output: 10 Watts Energy Dose: A typical effective dose for deep nerves is "800 J per session"
  • Другое Sham laser
    The device will beep and display as if it is working.
  • Другое Standard Conservative Care
    Education: Advice on avoiding tight belts/trousers, weight loss if applicable, and posture modification. -Home Exercise Program: Stretching exercises for the hip flexors (iliopsoas, rectus femoris) and tensor fasciae latae (TFL) to reduce tension on the inguinal ligament.

Первичные конечные точки

  • PainDETECT [Срок оценки: Baseline, 3rd week, 3rd months]

Критерии участия

Критерии включения

  • Adults aged 18-65 years.
  • Clinical diagnosis of MP (based on history: burning pain, tingling, numbness in the lateral thigh; tenderness over the inguinal ligament near the anterior superior iliac spine (ASIS); and a positive pelvic compression test or Tinel's sign over the lateral femoral cutaneous nerve (LFCN)).
  • Symptoms persistent for at least 3 months (chronic).
  • A baseline pain intensity of ≥4 on the Numeric Rating Scale (NRS).

Критерии исключения

  • Secondary MP (e.g., due to pelvic surgery, trauma, or tumor mass effect confirmed by imaging).
  • Significant lumbar radiculopathy (L1-L2).
  • Coagulopathy, use of anticoagulants.
  • Pregnancy.
  • Skin disease or infection in the treatment area.
  • Presence of a cardiac pacemaker.
  • Severe cognitive impairment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Usak University — Uşak

Идентификаторы

NCT: NCT07328360 · AYK&ES&NS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗