A Single-centre, Randomized Controlled Trial Investigating Clinical Utility and Cost-effectiveness of an Individualized Pedometer Driven Walking Programme for People With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Change in Oswestry Low Back Pain Disability Questionnaire score
研究概览
简要总结
This study will investigate if a 12-week, individually-tailored walking program, using pedometers will be a more clinically and cost-effective option for the management of chronic low back pain than standardized advice and education.
详细描述
Specific objectives of the study are:
- To determine perceived levels of disability and baseline levels of walking activity in a sample of those with chronic low back pain (CLBP)
- To determine the uptake and adherence to a pedometer-driven walking program for people with CLBP
- To test the clinical and cost-effectiveness of a walking programme to improve outcomes for CLBP compared to a standardized back care education package
- To test the feasibility of a walking programme in a sub-sample of rural Saskatchewan farmers/agricultural workers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females aged 18 years or over,
- •experiencing low back pain (i.e. between the 12th costal margin and gluteal fold with or without associated leg pain) persisting for a minimum of three months, and
- •assessed as capable of participating in a walking programme.
排除标准
- •any spinal surgery in the past 12 months;
- •evidence of nerve root, spinal cord, or cauda equina compression;
- •severe spinal stenosis indicated by signs of neurogenic claudication, grade 3 to 4 spondylolisthesis, fibromyalgia, or systemic/inflammatory disorder;
- •as well as any other current lower extremity musculoskeletal injury or contraindication to increasing physical activity (PA) levels.
- •The latter may include:
- •any cardiorespiratory or other medical condition limiting exercise tolerance;
- •history of serious psychological or psychiatric illness (mild depression eligible for inclusion); and/or
- •pregnancy.
研究组 & 干预措施
Standard/Control group
Each participant will receive a one-off individualized educational session regarding the management of chronic low back pain with a Physical Therapist: includes a physical examination, standardized advice & provision of the 'Back Book'.
干预措施: Standard (Behavioral)
Walking group
Each participant will receive a one-off educational session as per standard/control group followed by a 12 week graded, individually tailored, pedometer driven walking programme given by a Physical Therapist. Participants will be monitored each week and provided with encouragement and advice to increase the number of steps taken each day.
干预措施: Walking (Behavioral)
结局指标
主要结局
Change in Oswestry Low Back Pain Disability Questionnaire score
时间窗: Baseline, 12 weeks, 6 months and 12 months
次要结局
- Focus group data(Following 12 week intervention)
- Change in mean number of steps per day for each week of the study(Baseline & 12 weeks)
- Change in six minute walk test(Baseline, 12 weeks, 6 months & 12 months)
- Change in International Physical Activity Questionnaire score(Baseline, 12 weeks, 6 months & 12 months)
- Change in Back Beliefs Questionnaire score(Baseline, 12 weeks, 6 months & 12 months)
- Change in Exercise Self-efficacy Scale score(Baseline, 12 weeks, 6 months & 12 months)
- Change in Global rating of change for physical activity score(Baseline, 12 weeks, 6 months & 12 months)
- Change in health care usage and intervention costs over time(Baseline, 12 weeks, 6 months & 12 months)
- Change in Fear Avoidance Beliefs Questionnaire score(Baseline, 12 weeks, 6 months & 12 months)
- Change in Euroqual-5D score(Baseline, 12 weeks, 6 months & 12 months)
研究者
Stephan Milosavljevic
Principal Investigator
University of Saskatchewan