The Effect of Pain Education and Patient-led Goal Setting Compared to Guideline-based Written Information on Pain and Disability in Adults With Chronic Low Back Pain: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The goal of this clinical trial is to investigate the effectiveness of two treatments for adults with chronic low back pain. The main question this study seeks to answer is "In adults with chronic low back pain, what is the effectiveness of pain education and patient-led goal setting compared to guideline-based written advice on reducing pain intensity and disability?".
A total of 392 participants will be randomised into two groups: 1) pain education and patient-led goal setting or 2) guideline-based written advice. Participants randomised to the pain education and patient-led goal setting group will receive 5 sessions of 45-60 min each over 8 weeks delivered online via telehealth. Participants randomised to written advice group will receive information developed for people with chronic low back pain. Outcomes will be assessed at baseline and week 8, 26 and 52.
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
- None
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
- •Low back pain of at least 3 months duration
- •physically inactive (less than or equal to 150min/week moderate intensity physical activity; 75 min/week vigorous activity, or some combination of the two)
- •no known contraindication(s) to performing physical activity
- •English language proficiency
- •access to internet
排除标准
- •physically active (more than 150min/week moderate intensity physical activity, 75 min/week vigorous activity, or some combination of the two)
- •known contraindication(s) to performing physical activity
- •known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder)
- •scheduled for major surgery during the treatment or follow-up period
研究组 & 干预措施
Pain education and patient-led goal setting
Pain education and patient-led goal setting
干预措施: Pain education and patient-led goal setting (Other)
Written advice
Guideline-based written advice developed for people with chronic low back pain (e.g. https://pubmed.ncbi.nlm.nih.gov/34283182/)
干预措施: Guideline-based written advice (Other)
结局指标
主要结局
Pain intensity
时间窗: Week 26 post-randomisation
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale
Disability
时间窗: Week 26 post-randomisation
Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability
次要结局
- Pain intensity(Weeks 8 and 52 post-randomisation)
- Disability(Weeks 8 and 52 post-randomisation)
- Pain self-efficacy(Weeks 8, 26 and 52 post-randomisation)
- Back beliefs(Weeks 8, 26 and 52 post-randomisation)
- Kinesiophobia(Weeks 8, 26 and 52 post-randomisation)
- EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Weeks 8, 26 and 52 post-randomisation)
- Daily step count(Week 8 post-randomisation)
- Light intensity physical activity(Week 8 post-randomisation)
- Moderate-vigorous intensity physical activity(Week 8 post-randomisation)
- Sedentary time(Week 8 post-randomisation)
- Subjective physical activity levels(Weeks 8, 26 and 52 post-randomisation)
- Blood pressure(Week 8 post-randomisation)
- Adverse events(From randomisation to Week 8 post-randomisation)
- Adherence to treatment(From randomisation to Week 8 post-randomisation)
- Lifestyle risk factors(Weeks 8, 26 and 52 post-randomisation)
- Total healthcare costs(Weeks 8, 26 and 52 post-randomisation)
- Goal attainment (goal setting arm only)(Weeks 8, 26 and 52 post-randomisation)
研究者
Matthew Jones
Principal Investigator
Neuroscience Research Australia