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
- •Participants will be included if they meet the following criteria
- •Have been discharged <3 months from physiotherapy, chiropractic or osteopathic care following a course of treatment for LBP (pain in the area between the 12th rib and buttock crease)
- •Have non-specific LBP which is pain not attributed to a specific diagnosis such as sciatica, ankylosing spondylitis, vertebral fracture, etc.
- •Non-specific LBP sometimes called mechanical LBP accounts for ~85% of LBP diagnosis.
- •Between 18 and 80 years of age
排除标准
- •Participants will be excluded if they meet the following criteria:
- •Ongoing high pain intensity, defined as pain intensity of 6 or more on a 0-10 point scale. The cut off of 6/10 is used in the literature to dichotomise low/moderate to high pain intensity.
- •Co-morbidity preventing participation in physical activity evaluated using the Physical Activity Readiness Questionnaire (PAR-Q) from the American College of Sports Medicine guidelines
- •Inadequate English to complete outcome measures
- •Currently participating in an exercise program similar to the one we will evaluate.
- •History of spine surgery
研究组 & 干预措施
Physical activity in the community
The physical activity program will include an individualized exercise program delivered in community exercise facility plus education..
干预措施: Physical activity program (Other)
Control group standard care
Participants from the control group will receive no additional intervention other than being encouraged to continue with their physiotherapists or chiropractor recommendation which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity.
干预措施: Control group standard care (Other)
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
- 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)
- Activity limiting flare-up(3 and 6 months)
- Personal Impact of low back pain(3, 6, 12 months)
研究者
Luciana Macedo
Assistant Professor
McMaster University