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Набор скоро начнётся NCT06437314

Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain

Без фазы С лечением Low Back Pain Exercise Healthy

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: Aquatic program based on the back school.
Кому может быть актуально
Состояния в реестре: Low Back Pain, Exercise, Healthy. 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
Испания
Следующий шаг
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Официальное название

Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain: Randomized Controlled Trial

Обзор

A controlled and randomized clinical trial will be conducted, in which scores on dependent variable measures will be compared before and after the intervention, both in the experimental group (EG) (individuals who will attend the in an aquatic program based on the back school) and in the control group (CG) (individuals who will not attend the in an aquatic program based on the back school). The experimental procedure will follow the recommendations of the CONSORT and TidIER guidelines. The study protocol will be approved by the Research Ethics Committee of the University of Vigo. This study will be conducted under the Declaration of Helsinki (2013 version). Participants will sign a written informed consent after being informed of the benefits and risks of the research. Participants in the EG will participate in an aquatic program based on the back school. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports centre. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totalling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus and the other two will have a theoretical focus.

Вмешательства

  • Поведенческое Aquatic program based on the back school
    Participants will undertake a back school-based program. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports center. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totaling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus (centered on trunk exercises) and the o

Первичные конечные точки

  • Visual Analogue Scale. [Срок оценки: Through study completion, an average of 2 months.]
  • Roland Morris Disability Questionnaire. [Срок оценки: Through study completion, an average of 2 months.]
  • Short-Form Health Survey-36. [Срок оценки: Through study completion, an average of 2 months.]
  • Tampa Scale Of Kinesiophobia. [Срок оценки: Through study completion, an average of 2 months.]

Критерии участия

Критерии включения

  • 18-65 years of age.
  • With non-specific low back pain for at least three months, with pain intensity (30-70 on a VAS).

Критерии исключения

  • History of cancer, spine infection, rheumatologic diseases, history of spine fracture, history of trauma, red flag signs including unwanted weight loss (exceeding 10 percent of the total body weight) in the past six months and fever, history of psychological disease and history of spine surgery, radiculopathy, anatomical and congenital disturbance.
  • Missing more than two Back School sessions.
  • Not being able to attend the measurement sessions.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Beone Sport center — Pontevedra

Идентификаторы

NCT: NCT06437314 · EE acuático

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗