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Идёт набор NCT05953155

YOga for Patients with Chronic BACK Pain and Poor PROgnosis

Без фазы С лечением Low Back Pain Chronic Low-back Pain Back Pain Back Pain Lower Back Chronic

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: Control, Yoga.
Кому может быть актуально
Состояния в реестре: Low Back Pain, Chronic Low-back Pain, Back Pain, Back Pain Lower Back Chronic. Базовые параметры: 18 лет — 60 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
Бразилия
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

Effectiveness of YOga in Patients with Chronic Low BACK Pain and Poor PROgnosis (YOBACK-PRO Trial): a Randomized Controlled Trial

Обзор

The goal of this clinical trial is to investigate the effectiveness of yoga for patients with chronic low back pain and high risk of poor prognosis. The main question it aims to answer is: \- In patients with back pain and high risk of poor prognosis, what is the effectiveness of yoga plus education on reducing pain and disability compared to a control group receiving education alone? A total of 110 patients with chronic low back pain and classified as high risk of poor prognosis according to the Orebro Musculoskeletal Pain Screening Questionnaire (i.e. score ≥ 50 points out of 100) will be recruited for this study. Participants will be randomized into two groups: yoga and control. The yoga group will receive a 3-month course of yoga program consisting of two sessions per week and 3 educational classes. The control group will receive 3 educational classes over a 12-week period. Outcome measures will be assessed at baseline, at post-intervention (i.e. 3-months post randomization) and at 6-month follow up (i.e. 6-months post randomization).

Вмешательства

  • Другое Control
    Each educational class will last for 1 hour and consists of evidence-based information about low back pain, including, for example, self-management strategies, pain education, reassurance and common misconceptions about back pain.
  • Другое Yoga
    Participants in the intervention group will receive, in addition to the educational classes, a course of yoga program led by certified yoga instructors. The program consists of a 60-min group session with up to 10 participants, delivered twice a week for 12 weeks.

Первичные конечные точки

  • Disability [Срок оценки: Post-intervention (i.e. 3 months after randomisation)]
Вторичные конечные точки (5)
  • Disability [Срок оценки: 6 months after randomisation]
  • Pain intensity [Срок оценки: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]
  • Quality of life [Срок оценки: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]
  • Depressive symptoms [Срок оценки: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]
  • Pain self-efficacy [Срок оценки: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]

Критерии участия

Критерии включения

  • report chronic nonspecific LBP, defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds, with or without leg pain and of at least 3 months' duration.
  • score ≥ 50 points (out of 100) in the Orebro Musculoskeletal Pain Questionnaire.
  • have an average back pain intensity of 3 points or more on a 0-10 numerical pain rating scale.

Критерии исключения

  • serious spine pathology (e.g. tumors, fractures, and inflammatory diseases).
  • nerve root compromise (i.e. at least 2 of the following signs: weakness, reflex change, or sensation loss associated with the same spinal nerve).
  • previos spinal surgery.
  • pregnancy or having given birth within the previous 3 months.
  • any medical condition that prevented being physically active (e.g., serious cardiovascular, kidney or neurological diseases).
  • any other musculoskeletal condition that may affect activity and movement participation in a Yoga program during the last year.
  • not currently receiving other physical activity-based intervention (e.g., Pilates, physical therapy, aquatic exercise).
  • inadequate Portuguese literacy for the study's questionnaires and instructions.

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
Открытое
Основная цель
Лечение

Центры проведения

Бразилия · 1 центр
  • IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais — Belo Horizonte

Публикации

  • Nunes SM, Rizzo RR, Franco MR, Ferreira FR, Barros LJG, Maciel IT, Santos RL, Nascimento RR, Couto AJ, Quaresma LS, Fontes RM, Ferreira EMR, Maher CG, McAuley JH, Pinto RZ. Efficacy of YOga in people with chronic non-specific low BACK pain and poor PROgnosis (YOBACK-PRO): protocol for a randomised clinical trial. BMJ Open. 2026 Jan 28;16(1):e112982. doi: 10.1136/bmjopen-2025-112982. PMID 41605601

Идентификаторы

NCT: NCT05953155 · CAAE: 57028022.0.0000.5149

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗