Does targeting pain-related beliefs in people with knee osteoarthritis increase physical activity? A randomised, sham-controlled, feasibility trial.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
ine of ten people with knee osteoarthritis are inactive. Unhelpful pain beliefs may negatively influence physical activity levels. Targeting these unhelpful pain beliefs, via contemporary pain science education (PSE), may provide benefit. Here we aimed to evaluate the feasibility of conducting a clinical trial to determine the effect of adding PSE (vs adding sham ultrasound) to an individualised, physiotherapist-led education and walking program in people with painful knee osteoarthritis. Twenty participants were randomised (1:1) into the PSE or Control group, with clinical outcomes and physical activity (7 days of wrist-worn accelerometry) assessed at baseline, 4 (clinical outcomes only), 8, and 26 weeks. Feasibility criteria for recruitment, intervention adherence, viability of wrist-based accelerometry, and follow-up retention were set. Perceived intervention credibility, acceptability, usefulness from participants and clinicians were assessed. Our results showed that most feasibility criteria were met. We had sufficient recruitment, treatment compliance was high, and wrist-based accelerometry had >75% valid wear-time. However, Sufficient follow-up rates were not achieved (26 weeks: 65%). Participant and clinician feedback highlighted that PSE was too complex. Together this suggests that progression to a full trial is warranted. Strategies to increase participant retention and refine the PSE content/delivery are required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 o limit(—)
- 性别
- All
入选标准
- •Adults aged 50yrs and older
- •-Painful knee OA of at least 6 months duration that meets the American College of Rheumatology (ACR) clinical criteria for knee OA.
- •-Average knee pain (overall and/or during walking) over one week rated as greater than or equal to 40mm on a 0-100mm visual analogue scale (VAS)
排除标准
- •-Conditions that prevent safe participation in physical activity (e.g., severe cardiac/lung disease); neurological disorders affecting lower limb (e.g., stroke, multiple sclerosis); inflammatory arthritis; fibromyalgia
- •-Cognitive impairment (e.g., Alzheimer’s, dementia); severe depression (>21 on DASS24)
- •- Previous knee replacement (on painful knee) or planned knee replacement or surgery (next 6 months)
- •-Recent intra-articular therapy (past 3 months)
- •-Report moderate/vigorous activity levels above guideline recommendation (>150mins/wk; assessed via International Physical Activity Questionnaire; IPAQ)
- •-Do not have a radiograph or other imaging report of their affected knee
