BASICS: Back-pain Alleviation Via a Specific and Inexpensive Contextual Strength Training Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Oswetry Disability index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Leg pain greater than back pain
- •Neuromuscular disorders
- •Spinal or lower extremity fractures
- •Infections
- •Osteoporosis
- •Current substance abuse
- •Former lumbar surgery
- •Persistent pain syndromes other than back pain
- •Inflammatory rheumatic diseases
研究组 & 干预措施
Control
Low back pain patients not performing an intervention
Hip belt squat exercise
Low back pain patients performing hip belt squat training twice per week for 12 weeks.
干预措施: Hip belt squat exercise (Other)
结局指标
主要结局
Oswetry Disability index
时间窗: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
A questionnaire measuring the degree of disability, which ranges from 0 (no disability) to 100 (bedridden).
Health related quality of life
时间窗: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
A questionnaire measuring the easured health-related quality of life (EuroQOL-5D), ranging from -0.596 to 1, with higher scores indicating better quality of life.
Fear-avoidance Beliefs Questionnaire
时间窗: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
Fear-avoidance Beliefs Questionnaire (FABQ) measuring the amount of kinesiophobia, ranging from 0-96 with higher scores indicating higher levels of fear avoidance belief.
STarTBack tool
时间窗: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
A questionnaire used to assess the risk of chronicity in low back pain (ranging from low to medium to high risk).
Pain sensitivity
时间窗: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
Pressure-pain threshold was assessed using a handheld pressure algometer.
Pain intensity
时间窗: Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup
Patients were asked to rate the intensity of their LBP on a visual analog scale (VAS) using a 10 cm long line, where the far-left part of the line (0/10) corresponded to no pain and the far right part (10/10) corresponded to the worst imaginable pain. Ratings on the VAS scale was gathered both while the participants stood in an upright position and during a self-chosen movement known to induce pain (e.g. bending over).
次要结局
- Muscle strength(Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup)
- Lumbar flexibility(Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup)
- Body composition(Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup)
- Physical activity level(Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup)
- Tobacco use(Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup)
- Work related stress(Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup)
研究者
Mathias Kristiansen
Associate Professor
Aalborg University