The Effect of Mindfulness-Based Stress Reduction on Pain and Function in Persons With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
研究概览
简要总结
The purpose of this study is to see if stress reduction can lead to less pain due to knee osteoarthritis. To do this the investigators will compare two types of stress reduction modalities, Mindfulness-Based Stressed Reduction (MBSR) and a Health Enhancement Program (HEP). Both include stress reduction techniques, but MBSR has a mindfulness component that includes meditation. MBSR will be provided either in-person or online and HEP will be in-person. The assignment to the stress reduction program will be determined by the Principal Investigator. In order to assess for stress reduction and pain reduction the investigators will use validated measuring tools before, during, and after the course instructions.
详细描述
The current study is aiming to compare two stress reduction programs in order to see if stress reduction may lead to less pain due to knee osteoarthritis (OA). There are two stress reduction programs being compared, Mindfulness-Based Stress Reduction (MBSR) and a Health Enhancement Program (HEP). MBSR is a secular program that trains mindfulness meditation for stress reduction and to increase emotional regulation skills. It is defined as "paying attention in a particular way, on purpose, in the present moment, and non-judgmentally." Mindfulness refers to a set of meditation practices that develop a wide array of cognitive skills which include: attention regulation, response inhibition, and emotion regulation. HEP is an educational course intended to teach participants about their disease, factors influencing disease progression, nutrition, physical activity including walking and stretching, and functional movement. Key difference between these two is MBSR includes the mindfulness component, and MBSR will be taught either in-person or online. HEP will only consist of an in-person course.
The online MBSR course will be offered through: http://www.breathworks-mindfulness.org.uk/mindfulness-for-health. The investigators propose to use an active control training, the Health Enhancement Program (HEP), an intervention designed to isolate mindfulness as a testable active ingredient.
The duration of an individual subject's participation in the study will be at least 10 weeks starting from the screening visit all the way to the follow-up visit.
The in-person MBSR course consists of 8 weekly classes plus one all-day class between Weeks 6 and 7, and is sequential. Depending on when a participant is consented, they may have to wait until a new 8-week course is available in order to begin. The HEP course also consists of 8 weekly classes and will start when a group of 7-10 participants have been assigned to the HEP intervention. The online MBSR course is designed to last 8 weeks and can be started at any time.
Since initiation of the in-person MBSR or HEP courses will depend upon when subjects are enrolled, it is not possible to provide the maximum length of time for a subject's participation. However long the subject's participation, they are only expected to complete 2 in-clinic visits and 8 weeks of class (plus 1 all-day class for MBSR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study will be structured as a parallel-group controlled trial. The Principal Investigator will assign participants into the three groups. This will allow for equalization of distribution of participants across the three groups. It will not be possible to blind the participants to which arm of the trial they are participating in, as the content or lack thereof of their activities will be obvious to them. For results analysis, collaborators at the UCD West Coast Metabolomics Center will be blinded to the treatment of the respective samples, thus eliminating potential bias during analysis.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive "Frequent Knee Pain" question
- •Radiographically confirmed knee OA (Kellgren/Lawrence ≥ 2)
排除标准
- •Scheduled to have knee replacement surgery within 6 months from enrollment
- •Rheumatoid arthritis or another inflammatory arthritis
- •Known avascular necrosis (death of bone due to lack of blood supply)
- •Failure to comply with run-in procedures: poor attendance or non-compliant with completing the activity
- •Major psychiatric illness, cognitive impairment or alcohol/substance abuse
- •Non-English speaking
结局指标
主要结局
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
时间窗: At First Clinical Visit (Baseline Week 1), During Treatment (Once per week for 8 Weeks), at Second Clinical Visit (Post-Treatment Week 10), this will be done through the participant's duration in the study on average lasting 10 weeks.
A joint specific questionnaire used to measure the condition of patients with knee osteoarthritis, pain, stiffness, and physical functioning of the inflicted joints. Each question is answered by selecting a box from a scale of 0-10 (0=No Pain, 10=Extreme Pain). The investigators plan on collecting a baseline measurement prior to the treatment, weekly measurements through the treatment (1 per week for 8 weeks), and another after the treatment is completed to track changes.
次要结局
- Change in Emotion Regulation Questionnaire (ERQ)(At First Clinical Visit (Baseline Week 1), Mid-Treatment (Week 5), at Second Clinical Visit (Post-TreatmentWeek 10), this will be done through the participant's duration in the study on average lasting 10 weeks.)
- Change in Oxylipin Plasma Levels(At First Clinical Visit (Baseline Week 1) and at Second Clinical Visit (Post-Treatment Week 10))
- Change in Cytokine Plasma Levels(At First Clinical Visit (Baseline Week 1) and at Second Clinical Visit (Post-Treatment Week 10))
- Change in 5 Facet Mindfulness Questionnaire (FFMQ)(At First Clinical Visit (Baseline Week 1), Mid-Treatment (Week 5), at Second Clinical Visit (Post-Treatment Week 10), this will be done through the participant's duration in the study on average lasting 10 weeks.)
- Change in Plasma Cortisol Levels(At First Clinical Visit (Baseline Week 1) and at Second Clinical Visit (Post-Treatment Week 10))
- Change in Pain Catastrophizing Scale (PCS)(At First Clinical Visit (Baseline Week 1), Mid-Treatment (Week 5), at Second Clinical Visit (Post-Treatment Week 10), this will be done through the participant's duration in the study on average lasting 10 weeks.)