Reducing Knee Compression Loading When Sleeping Supine (on the Back): Benefits in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- change in KOOS Knee Pain
研究概览
简要总结
To determine whether a change in sleeping position so as to prevent the knee being 'pushed' into full extension when lying supine provides pain relief and/or symptom improvement in individuals with knee osteoarthritis (OA).
详细描述
Only those who normally sleep lying on their back will be recruited. Participants will be recruited into two groups: Group 1, 'intervention'; Group 2, 'control'. Participants in group 1 will be asked to change the position they lie on their bed when sleeping; that is, to re-position themselves when lying on their back so that their feet (and ankles) hang over the end of the mattress. Participants in group 2 will be asked to make no change in the way they normally lie on their mattress when sleeping.
Participants will be asked to complete a questionnaire, asking them about the pain and/or discomfort they are currently experiencing, and their current level of physical functioning. The questionnaire used will be the Knee Injury and Osteoarthritis Outcome Score (KOOS) which has been widely used to assess intervention outcomes in individuals with knee OA. They will be asked to complete this questionnaire three times over a 4-month period; for Group 1 this will be before (x2) and after (x1) changing to the new sleeping position (i.e. day of consent, 1 month later on day of change, and 3 months after change); for Group 2 this will be matching the intervals in the intervention group. The primary outcome measure will be the KOOS Pain score, which will be compared pre and post- changing to the new sleeping position.
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
- 是
入选标准
- •presence of mild, moderate or severe tibiofemoral-OA (radiologically determined in either or both knees)
- •regularly (routinely) spend periods lying on their back when sleeping.
排除标准
- •those with: rheumatoid arthritis
- •chronic cardiopulmonary problems
- •lower-limb joint(or joint surface) replacement and/or previous knee surgery within previous 12 months
- •unable to lie supine in bed (medical or practical reason)
- •diagnosed with inflammatory arthropathy
- •peripheral neuropathy or other sensory problems
- •steroid injection in the knee within previous 3 months
- •under 18 years of age
- •unable to give consent due to lack of mental capacity
- •currently involved in any research study related to knee OA.
结局指标
主要结局
change in KOOS Knee Pain
时间窗: baseline and 3 months (post intervention)
Knee injury and Osteoarthritis Outcome Scores (KOOS) - sub-scale Pain, from 0 (worst) to 100 (best)
次要结局
- change in KOOS Knee (other sub-scales)(baseline and 3 months (post intervention))
研究者
John G Buckley
Principal Investigator
University of Bradford