Набор скоро начнётся NCT06833346

Efficacy of Hip Belt Squat Training on Pain Management and Physcial Function in Low Back Pain Patients

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: Hip belt squat exercise.
Кому может быть актуально: Состояния в реестре: Low Back Pain. 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: Дания
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

BASICS: Back-pain Alleviation Via a Specific and Inexpensive Contextual Strength Training Protocol

Обзор

The purpose of this project is to investigate the efficacy of the hip belt squat exercise in pain management and physical function for people with chronic low back pain.

Подробное описание

This study is a randomized controlled trial (RCT) designed to evaluate the effectiveness of a 12-week hip belt squat (HBS) intervention for patients with non-specific low back pain (LBP). Participants, aged 18-60 with LBP for more than 12 weeks, are randomly assigned to either the intervention group or a control group. The control group will not receive any intervention, whereas the HBS intervention consists of two supervised sessions per week for 12 weeks, with load adjustments based on perceived exertion.

The study aims to recruit 50-60 patients to ensure sufficient statistical power. Primary outcomes include health-related quality of life (EQ-5D-5L), fear-avoidance beliefs (FABQ), functional ability (ODI), risk of chronicity (STarTBack), pain intensity (VAS), and pain sensitivity (PPT). Secondary outcomes include body composition (DEXA), lumbar flexibility, maximal muscle strength (5RM), physical activity (GPAQ), tobacco use (SQ), and work-related stress (WSQ).

Measurements are taken at baseline, 6 weeks, 12 weeks, and a 1-year follow-up for various outcomes. This comprehensive approach aims to provide valuable insights into the effectiveness of the HBS intervention for managing LBP.

Вмешательства

Другое Hip belt squat exercise
Hip belt squat exercise performed twice per week for 12 weeks

Первичные конечные точки

Oswetry Disability index [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
Health related quality of life [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
Fear-avoidance Beliefs Questionnaire [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
STarTBack tool [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
Pain sensitivity [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
Pain intensity [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]

Вторичные конечные точки (6)

Muscle strength [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
Lumbar flexibility [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
Body composition [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
Physical activity level [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
Tobacco use [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]
Work related stress [Срок оценки: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup]

Критерии участия

Критерии включения

Men and women with non-specific low back pain for more than twelve weeks, with a VAS score of at least 3, taken as an average of the last week, and ODI>20