Community Based Secondary Prevention of Back Pain Flare-ups (Back2LiveWell): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Activity limiting flare-up
研究概览
简要总结
The primary objective of this study is to compare the effectiveness and cost-effectiveness of an individualized group based exercise and education program supported in the community to a control group of usual care in preventing back pain flare-ups and to mitigate the negative consequences of subsequent episodes if they occur.
详细描述
Secondary objectives are to:
• To compare the effectiveness of the two interventions in preventing an activity-limiting LBP flare up at 12 and 24 months.
Secondary objectives are to:
- To compare the effectiveness of the interventions in mitigating the negative consequences of LBP.
- To evaluate the cost-effectiveness of the interventions in preventing activity-limiting LBP flare-up.
- To identify subgroups of individuals that may best respond to each one of the two interventions.
Exploratory objectives include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Given that this is an exercise study blinding of participants and those delivering the exercise program will not be possible. Outcome measures will be collected by an investigator not aware of treatment allocation, but most outcome measures will be self-reported and thus, true assessor blinding will no be possible. All statistical analysis will be conducted by a blinded investigator.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Activity limiting flare-up
时间窗: 12 months
* flare-up is an increase in pain levels of greater than or equal to 3 on a 0-10 numeric pain scale. The LBP international consensus on minimal important change in pain is 2 on a 0-10 scale and thus a change of 3 is likely be clinically important.15 * activity-limiting LBP will be measured using an adaptation of the item PI9 of the PROMIS item bank. (How much did LBP interfere with your day to day activities?) A score of 3 or greater (representing somewhat impact) on a 1-5 scale will be considered as activity limitation. Participants will fit the criteria for activity-limiting flare-up if pain increases at least 3 points AND pain is identified to be limiting on the PI9 as described above. Flare-up will be collected once a week for 1 year
次要结局
- Activity limiting flare-up(3 and 6 months)
- Personal Impact of low back pain(3, 6, 12 months)
- Pain intensity _NRS pain(3, 6, 12 months)
- Disability(3, 6, 12 months)
- Function(3, 6, 12 months)
- Health related Quality of Life: EQ-5D-5L(3, 6, 12 months (0-100))
- Physical activity questionnaire(3, 6, 12 months)
- Physical activity level(3, 6, 12 months)
研究者
Luciana Macedo
Assistant Professor
McMaster University