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Набор по приглашению NCT07461363

Efficacy of Low-Dose Laser Acupuncture for Low Back Pain

Без фазы С лечением Chronic Low Back Pain

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: Low-Dose Laser Acupuncture, Sham Laser Acupuncture.
Кому может быть актуально
Состояния в реестре: Chronic Low Back Pain. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Low-Dose Laser Acupuncture on Low Back Pain: A Randomised Control Trial

Обзор

This study will evaluate whether low-dose laser acupuncture can reduce pain and improve daily function in adults with chronic low back pain. The trial is a double-blinded, randomized, two-arm, parallel, multi-centred study.

Вмешательства

  • Устройство Low-Dose Laser Acupuncture
    Low-dose laser acupuncture delivered using an AlGaAs laser device (Aculas-AM-100 Multi-channel Digital LLLT System; 780 nm; 80 mW). Laser modules are taped to 10 bilateral acupoints. Active laser dose is 4.19 J/cm³ delivered over 20 minutes (1200 s) with a 3 cm² treatment area. Core acupoints: BL23, BL24, BL25, BL40; optional (one pair) for concomitant pain: BL17 or BL52 or BL37. Up to 6 sessions (week 3) with option to continue to 12 sessions (week 6).
  • Устройство Sham Laser Acupuncture
    Sham laser acupuncture: laser modules are taped to the same 10 bilateral acupoints and sessions follow the same schedule as the active group, but the laser is not activated (no laser energy delivered). Participants cannot see the modules/machine while lying face down.

Первичные конечные точки

  • Pain intensity (VAS) [Срок оценки: Baseline (Visit 1, Week 1); End of treatment (Visit 6 at Week 3 or Visit 12 at Week 6, whichever is the participant's last treatment visit); 3 months after end of treatment.]
  • Global Assessment of Pain [Срок оценки: Visit 2 through end of treatment (Visit 6 at Week 3 or Visit 12 at Week 6, whichever is the participant's last treatment visit); 3 months after end of treatment.]
  • Functional disability (ODI) [Срок оценки: Baseline (Visit 1, Week 1); End of treatment (Visit 6 at Week 3 or Visit 12 at Week 6, whichever is the participant's last treatment visit); 3 months after end of treatment.]
  • Functional disability (RMDQ) [Срок оценки: Baseline (Visit 1, Week 1); End of treatment (Visit 6 at Week 3 or Visit 12 at Week 6, whichever is the participant's last treatment visit); 3 months after end of treatment.]
Вторичные конечные точки (5)
  • Sustained pain intensity at 3 months (VAS) [Срок оценки: 3 months after completion of treatment (phone follow-up conducted 3 months after Visit 6 or Visit 12, whichever is the participant's last treatment visit).]
  • Sustained functional disability at 3 months (ODI) [Срок оценки: 3 months after completion of treatment (phone follow-up conducted 3 months after Visit 6 or Visit 12, whichever is the participant's last treatment visit).]
  • Sustained pain improvement at 3 months (Global Assessment of Pain) [Срок оценки: 3 months after completion of treatment (phone follow-up conducted 3 months after Visit 6 or Visit 12, whichever is the participant's last treatment visit).]
  • Safety profile (adverse events) [Срок оценки: Visit 1 (Week 1) through end of treatment (Visit 6 at Week 3 or Visit 12 at Week 6, whichever is the participant's last treatment visit); 3 months after end of treatment (phone follow-up).]
  • Patient acceptance of laser acupuncture [Срок оценки: After each treatment session during the treatment period: after Visits 1-6 (Weeks 1-3) and, if applicable, after Visits 7-12 (Weeks 4-6).]

Критерии участия

Критерии включения

  • Low back pain for ≥12 weeks
  • Pain intensity VAS ≥3 cm at Visit 1 (baseline)
  • Age 18-65 years
  • Able and willing to provide written informed consent
  • Able and willing to attend treatment sessions at Pusat Sejahtera, Universiti Sains Malaysia and complete the 3-month follow-up phone assessment

Критерии исключения

  • Pregnant or planning pregnancy; females unwilling to use pregnancy prevention during the study
  • Current or past history of trauma or cancer
  • Prior spine surgery
  • Severe infection (e.g., tuberculosis, pyogenic abscess)
  • Fever ≥38°C lasting ≥48 hours at recruitment
  • Cauda equina syndrome
  • Significant spinal cord compression with serious disability (per medical history)
  • Osteoporosis requiring pharmacologic treatment
  • Severe dementia, cognitive impairment, other major cerebral disease, or severe psychiatric/psychological disorder
  • Significant renal or hepatic disease
  • BMI ≥34.9 kg/m²
  • History of recreational drug abuse
  • Use of systemic steroids within the past 6 months
  • Use of any analgesics (including paracetamol) within the past 30 days
  • Acupuncture treatment within the past 30 days

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

Китай · 1 центр
  • The First Affiliated Hospital of Xinxiang Medical University — Xinxiang

Идентификаторы

NCT: NCT07461363 · EC-025-663

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗