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Набор скоро начнётся NCT07550569

Effectiveness of High Intensity Laser Therapy in Management of Lumbar Disc Herniation

Без фазы С лечением Lomber Disc Herniation

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: Hiltherapy, physiotherapy.
Кому может быть актуально
Состояния в реестре: Lomber Disc Herniation. 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
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Обзор

Chronic lumbar radiculopathy is a multifactorial condition typically caused by lumbar disc herniation, where degenerative changes lead to nerve root compression, resulting in radiating pain, sensory disturbances, and motor deficits. Management requires a multidisciplinary, primarily conservative approach centered on physical therapy, including exercise, electrotherapy, and other non-invasive modalities. Exercise plays a key role in improving spinal stability, mobility, posture, and neuromuscular coordination, while treatments like transcutaneous electrical nerve stimulation (TENS) and high-intensity laser therapy (HILT) provide pain relief through neuromodulation and tissue regeneration mechanisms. Recent evidence suggests that combining HILT with exercise may enhance functional outcomes more effectively than exercise alone. Accordingly, this study aims to compare the effectiveness of exercise alone, exercise combined with HILT, and exercise combined with conventional therapies (ultrasound, hot pack, and TENS) in patients with lumbar disc herniation. Patients aged 18-65 will be randomly assigned to three groups and undergo a 3-week treatment program, with outcomes assessed through measures of pain, disability, range of motion, and quality of life.

Подробное описание

Chronic lumbar radiculopathy is a complex condition resulting from mechanical or inflammatory irritation of lumbar spinal nerve roots, most commonly due to lumbar disc herniation (LDH). In LDH, degeneration of the intervertebral disc leads to rupture of the annulus fibrosus and extrusion of the nucleus pulposus, compressing neural structures particularly at the L4-L5 and L5-S1 levels. This produces symptoms such as radiating low back pain, paresthesia, and motor dysfunction. Management of this condition requires a multidisciplinary and predominantly conservative approach, with physical medicine and rehabilitation forming the cornerstone. Treatment options include pharmacological therapy, manual therapy, physical modalities, and especially structured exercise programs. Exercise is essential not only for symptom relief but also for preventing recurrence, as it improves spinal stability, flexibility, posture, and neuromuscular coordination. Specific exercise types such as core strengthening, mobility, stabilization, postural correction, and proprioceptive training-target the underlying biomechanical and functional impairments associated with low back pain.

In addition to exercise, electrotherapy modalities such as transcutaneous electrical nerve stimulation (TENS) and high-intensity laser therapy (HILT) have gained increasing attention. TENS, approved by the FDA in 1976, reduces pain through mechanisms such as the gate control theory and endorphin release, with adjustable parameters allowing modulation of superficial and deep tissues. It is particularly useful for managing movement-related pain when applied before or after exercise. HILT, using a 1064 nm Nd:YAG laser, delivers high-energy pulses that penetrate deep tissues and provide analgesic, anti-inflammatory, and biostimulatory effects. It enhances mitochondrial activity, increases ATP production, improves microcirculation, promotes tissue repair, and reduces edema, thereby alleviating pressure on neural structures. Clinical studies have demonstrated that HILT is effective in reducing pain and improving function in patients with LDH, particularly when combined with exercise, and may lead to sustained improvements in quality of life.

Based on this evidence, the presented study is designed to compare the effectiveness of three treatment approaches in patients with lumbar disc herniation: exercise alone, exercise combined with HILT, and exercise combined with conventional physical therapy modalities (ultrasound, hot pack, and TENS). The study will include patients aged 18-65 diagnosed via MRI, with strict inclusion and exclusion criteria to ensure a homogeneous sample. Participants will be randomly assigned to one of the three groups and undergo a 3-week intervention consisting of 15 supervised sessions. The exercise program includes lumbar extension, pelvic tilt, and core stabilization exercises. The HILT protocol involves a structured application of Nd:YAG laser with specific energy and frequency parameters, while the conventional therapy group receives a combination of hot pack, ultrasound, and TENS. Outcomes will be evaluated using lumbar range of motion measurements, pain intensity via the Visual Analog Scale (VAS), functional disability via the Oswestry Disability Index (ODI), and quality of life via the SF-36 questionnaire. Overall, the study aims to determine the most effective conservative treatment strategy for improving pain, function, and quality of life in patients with lumbar disc herniation.

Вмешательства

  • Устройство Hiltherapy
    Nd:YAG laser (1064 nm) will be applied to the participants with high-peak power (3 kW), pulse duration 120-150 μs, frequency 10-30 Hz, energy density 360-1780 mJ/cm². Protective eyewear will be used. Protocol: scanning phase (rapid paravertebral scan), initial phase (trigger point scan), and final phase (slow scan of initial area). Total energy: 2,500 J/cm² (1,000 + 500 + 1,000). 15 sessions for 3 weeks, 15 min/session.
  • Устройство physiotherapy
    Combination of US + Hot pack + TENS will be applied to the participants Hot pack (15 × 50 cm, 15 min), ultrasound (1 MHz, 1.5 W/cm², 4+4 min bilateral), and TENS (20 min, 80 Hz, 180 μs, 4 electrodes 5 × 5 cm) for 15 sessions for 3 weeks.

Первичные конечные точки

  • Visual Analog Scale [Срок оценки: 3 months]
Вторичные конечные точки (2)
  • • Functional disability via Oswestry Disability Index [Срок оценки: 3 months]
  • Short form-36 [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • Males and females aged 18-65 years
  • Diagnosed with lumbar disc herniation via MRI and presenting with low back pain
  • No History of lumbar physical therapy in the last 3 months
  • No History of analgesic or muscle relaxant use since initial presentation
  • Willingness to participate and signed informed consent

Критерии исключения

  • History of Fibromyalgia diagnosis
  • History of acute trauma
  • History of Lumbar instability
  • History of Rheumatologic disease
  • Motor deficits or myelopathy
  • History of Lumbar injections in the last 3 months
  • History of Previous lumbar surgery
  • Pregnancy
  • Pacemaker
  • Cognitive impairment or unwillingness to comply with treatment

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 3 центра
  • Baskent University — Ankara
  • Baskent University — Ankara
  • Başkent University Ankara Hospital — Ankara

Идентификаторы

NCT: NCT07550569 · KA25/356

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗