Reinforcement of Placebo Response in Knee Osteoarthritis: A Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- VAS knee pain
研究概览
简要总结
Saline intra-articular injections used as placebo treatments have been shown to provide pain relief in knee osteoarthritis (OA) It has further been shown that beneficial effects can be induced merely by having a conversation with a health professional.
The aim of this study is to determine whether an individual conversation based on the individual's illness perception related to knee OA affects the response to an intra-articular treatment with saline in individuals with knee OA.
详细描述
Despite many years of research, there is still considerable uncertainty on what causes placebo effects and how these are mediated. Saline is a pharmacologically inert agent frequently used as placebo comparator in clinical trials of intra-articular (IA) treatments for knee osteoarthritis (OA) and patients often experience a significant pain improvement from this treatment even when it is administered as an open label placebo treatment.
It has further been shown that beneficial effects can be induced merely by having a conversation with a health professional and several studies have found the alliance between therapist and patient to have a positive effect on treatment outcome in physical rehabilitation indicating that positive attention by itself leads to beneficial treatment outcomes. Still it is unclear wether the effect of an open label placebo treatment can be influenced by a conversation and if the extent of this infleuence depends on the focus of the conversation.
The aim of this study is to determine whether a conversation about the individual's illness perception related to knee OA affects the response to a placebo treatment (saline injection) in individuals with knee OA.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The participants are masked as to which intervention (conversation) is considered the actual intervention. Therapists doing physical tests are blinded to treatment allocation
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years
- •A clinical diagnosis of tibiofemoral OA in the target knee according to the American College of Rheumatology
- •Average knee pain in the last week during weight bearing activities of at least 4 on a 0 to 10 points scale (0=no pain; 10=worst possible pain).
排除标准
- •Not able to speak or understand Danish
- •Scheduled surgery during study participation
- •History of target knee surgery within 12 months
- •History of arthroplasty in the target knee
- •Injection therapy in either knee within 3 months
- •Current use of oral glucocorticoids
- •Current use of synthetic or non-synthetic opioids
- •Contraindications to intra-articular injections, such as wounds or skin rash over injection site.
- •Planning to start or discontinue other treatment for knee OA in the study participation period
- •Inflammatory arthritis, such as rheumatoid arthritis or psoriatic arthritis.
- •Regional pain syndromes
- •Generalised pain syndromes such as fibromyalgia
- •Lumbar or cervical nerve root compression syndromes
- •Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as large knee joint effusion, uncontrolled diabetes, psychiatric and/or neurological disorders, or opiate dependency
结局指标
主要结局
VAS knee pain
时间窗: Week two, change from baseline
Knee pain defined as "the average level of pain in your knee today" will be assessed with a 100 mm visual analogue scale (VAS) with anchors 0 = "no pain" and 100 = "Worst imaginable pain".
次要结局
- The effect of knee pain variability (VAS) prior to the intervention(Week 0, Change from week -1)
- Stair climbing test(Week two, change from baseline)
- 4x10 meter fast walk test(Week two, change from baseline)
- Synovial hypertrophy score(Week two, change from baseline)
- Doppler activity score(Week two, change from baseline)
- Self-reported paracetamol and ibuprofen use for knee pain(Week two, change from baseline)
- Expectations for Treatment Scale (ETS)(Week 0, change from week -1)
- Brief Illness perception questionnaire(Week two, change from baseline)
- Knee injury and Osteoarthritis Outcome Score(Week two, change from baseline)
- The 30 seconds sit to stand test(Week two, end of trial, change from baseline)
研究者
Marius Henriksen
Professor
Frederiksberg University Hospital