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Идёт набор NCT06938568

Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain

Без фазы С лечением Exercise Therapy 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: Personalized back exercises, Non-personalized back exercises.
Кому может быть актуально
Состояния в реестре: Exercise Therapy, 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
Швейцария
Следующий шаг
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Обзор

Personalized medicine and individualized therapeutic approaches are prominent in current research. But are these approaches also effective for treating non-specific low back pain (NSLBP)? NSLBP is one of the most common musculoskeletal issues, which can impair physical well-being, reduce the quality of life, and limit physical functioning. Additionally, it contributes to substantial direct and indirect healthcare costs, such as frequent doctor visits and work absences. Despite NSLBP being a significant burden for both individuals and society, effective alleviation methods remain unclear. The investigators' research project therefore aims to investigate whether personalized therapy, specifically a personalized physical back training program, can effectively address NSLBP. Within the context of NSLBP, the investigators' specific aim is to improve physical functioning as this outcome is considered relevant from all perspectives, including those of patients, clinical professionals, researchers, and guidelines.

Вмешательства

  • Другое Personalized back exercises
    The study intervention is a 12-week personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are selected through a clinical reasoning process, i.e., they are tailored and problem-oriented, based on the results of a clinical assessment. An initial one-on-one training session will take place to familiarize participants with the back training program, corresponding to the first week
  • Другое Non-personalized back exercises
    The active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are not selected through a clinical reasoning process, i.e., they are neither tailored nor problem-oriented nor based on the results of a clinical assessment. An initial one-on-one training session will take place to familiarize participants with the back training program, cor

Первичные конечные точки

  • Self-rated physical functioning [Срок оценки: Baseline to 12 weeks]
Вторичные конечные точки (6)
  • Self-rated physical functioning [Срок оценки: Baseline to 4, 8, and 24 weeks]
  • Self-rated physical functioning (RMDQ) [Срок оценки: Baseline to 4, 8, 12, and 24 weeks]
  • Health-related quality of life (EQ-VAS) [Срок оценки: Baseline to 4, 8, 12, and 24 weeks]
  • Health-related quality of life (EQ-5D-5L) [Срок оценки: Baseline to 4, 8, 12, and 24 weeks]
  • Pain intensity (NRS) [Срок оценки: Baseline to 4, 8, 12, and 24 weeks]
  • Safety outcome [Срок оценки: During the 12 week intervention period]

Критерии участия

Критерии включения

  • Access to the University Sports of the Lucerne Universities (i.e., students, employees, alumni, subscribers)
  • NSLBP for at least 6 weeks
  • Activity limiting NSLBP (at least one activity with a PSFS Score of ≤ 50/100 on a scale from 0 = unable to perform due to NSLBP to 100 = able to perform at the same level as before NSLBP)
  • Age between 18 and 65 years
  • Understand the German language
  • Willing to participate in the study
  • Written informed consent

Критерии исключения

  • Specific LBP
  • Red flags associated with any serious pathology or specific LBP,
  • Being on a waiting list for or less than 12 months post any surgery of the lower back
  • Pregnancy or given birth within the last 12 months
  • Diagnosed central neurological disease
  • Not allowed to exercise
  • Participant in the feasibility study
  • Expecting to be absent for more than 2 weeks during the intervention period

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Швейцария · 1 центр
  • University of Lucerne, Faculty of Health Sciences and Medicine, University Research Centre — Lucerne

Идентификаторы

NCT: NCT06938568 · 2024-01285 · 63674

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗