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Идёт набор NCT05679167

Digital Training Interventions for Low Back Pain

Без фазы С лечением 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: Supervised digital training with focus on core stability, Supervised digital training with focus on aerobic exercise, Non-supervised daily physical activity.
Кому может быть актуально
Состояния в реестре: Low Back Pain. Базовые параметры: 18 лет — 50 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
Швеция
Следующий шаг
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Официальное название

Digital Training Interventions for Low Back Pain - RCT With Longitudinal Evaluation of Clinical Outcome Measures and MRI Examinations

Обзор

The patients will be clinically examined, as well as evaluated with Patient Reported Outcome Measures (PROMs) and Magnet Resonance Imaging (MRI) at baseline and at follow-ups.

Подробное описание

The overall aim is to evaluate two different types of digital training interventions supervised by physiotherapists compared to daily physical activity in terms of clinical, imaging-based and patient-reported outcome in patients with low back pain. Furthermore, to evaluate whether new diagnostic MRI methods can identify longitudinal spine tissue changes and to analyse if there is an exercise-related difference.

Patients seeking primary health care for lower back pain will be randomized to three groups. The patients will be clinically examined, assessed with Magnet Resonance Imaging (MRI) and Patient Reported Outcome Measures (PROMs) will be evaluated at baseline and at follow-ups.

A detailed description of the study protocol, see attached document.

Вмешательства

  • Поведенческое Supervised digital training with focus on core stability
    After randomization, Group 1 will be digitally supervised by experienced physiotherapist.
  • Поведенческое Supervised digital training with focus on aerobic exercise
    After randomization Group 2 will be digitally supervised by experienced physiotherapist.
  • Поведенческое Non-supervised daily physical activity
    After randomization Group 3 will receive training instruction regarding daily physical activity.

Первичные конечные точки

  • Change in Patient-reported pain [Срок оценки: 6 months compared to baseline]
  • Change in Patient-reported pain [Срок оценки: 12 months compared to baseline and 6 months]
  • Difference in T2 (transverse relaxation time) [Срок оценки: 6 months compared to baseline]
  • Difference in T2 (transverse relaxation time) [Срок оценки: 12 months compared to baseline and 6 months]
Вторичные конечные точки (12)
  • Change in clinical outcomes (Standing inspection) [Срок оценки: 6 months compared to baseline]
  • Change in clinical outcomes (Standing side-to-side symmetry) [Срок оценки: 6 months compared to baseline]
  • Change in Clinical outcomes (Muscle hypotrophy) [Срок оценки: 6 months compared to baseline]
  • Change in Clinical outcomes (Walking on heels) [Срок оценки: 6 months compared to baseline]
  • Change in Clinical outcomes (Walking on toes) [Срок оценки: 6 months compared to baseline]
  • Change in Clinical outcomes (Standing inspection) [Срок оценки: 12 months compared to baseline and 6 months]
  • Change in Clinical outcomes (Standing side-to-side symmetry) [Срок оценки: 12 months compared to baseline and 6 months]
  • Change in Clinical outcomes (Muscle hypotrophy) [Срок оценки: 12 months compared to baseline and 6 months]
  • Change in Clinical outcomes (Walking on heels) [Срок оценки: 12 months compared to baseline and 6 months]
  • Change in Clinical outcomes (Walking on toes) [Срок оценки: 12 months compared to baseline and 6 months]
  • Change in Functional tests (Sit-to-stand test) [Срок оценки: 6 months compared to baseline]
  • Change in Functional tests (Prone-bridge test) [Срок оценки: 6 months compared to baseline]

Критерии участия

Критерии включения

  • Low back pain> 3 months
  • Age 18-50 years
  • Access to computer/tablet/mobile phone

Критерии исключения

  • Inadequate Swedish as the language is an obstacle to be able to fully understand written and oral information regarding the project and to follow training instructions
  • Other ongoing treatment/exercise for their low back pain
  • Patients with radiating leg pain and neurological symptoms where herniated discs are suspected
  • Previous back/neck surgery
  • Pregnancy
  • Diagnosed systematic diseases engaging the spine as rheumatoid arthritis, ankylosing spondylitis
  • Factors that prevent an MRI examination, such as claustrophobia, metal implants, etc.

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

Швеция · 1 центр
  • Ninni Sernert — Vänersborg

Идентификаторы

NCT: NCT05679167 · Vastra Gotaland

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗