Feasibility of Pain Informed Movement for People With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Acceptability of Content
研究概览
简要总结
The pain experience and its associated mechanisms in people with knee osteoarthritis (OA) are known to be complex and multidimensional. The current understanding of OA pain mechanisms is incomplete, resulting in limited pain management strategies. There is high-quality evidence that suggests the use of exercise for people with knee OA can provide a reduction in pain, changes in quality of life, and have modest improvements in physical function. There is promising evidence to support that yoga for those with knee OA may improve pain intensity, function, and stiffness. The aim of this study is to establish the feasibility of a pain informed movement program, in addition to education for improving pain modulation. The data collected will be used to inform a pilot and feasibility randomized controlled trial (RCT) prior to a multi site RCT to assess the program's effectiveness with the primary outcome of change in pain severity mediated by change in descending modulation.
详细描述
Background
Exercise is regularly utilized as a first-line treatment for knee osteoarthritis, and its use is supported by high quality evidence to improve pain and function. Reductions in perceived pain can be explained in part by exercised-induced analgesia, which is thought to be mediated via numerous endogenous pathways. Furthermore, decreased nervous system sensitivity to noxious stimuli seem to play a role in the decreased pain experience of individuals who engage in exercise. These mechanisms likely play a role in improved function and reduced pain along with the improved balance, muscle strength and flexibility that are conventionally associated with exercise. In recent years multiple guidelines for non-surgical management of knee OA have begun to include mind-body therapies, such as yoga or tai-chi, as conditional or core treatment recommendations. Structured yoga programs have been shown to result in decreased pain and improved function when compared to no exercise and conventional exercise.
BDNF is a neurotrophin that appears to play an important role in the central modulation of pain in adults, and altered expression of BDNF is likely to play an important role in the pathophysiology of chronic pain. Individuals with knee OA have been shown to possess altered levels of serum BDNF compared to healthy controls, indicating that BDNF may be implicated in the pain-experience of patients with knee OA. Thus, BDNF has been identified as a therapeutic target in the treatment of pain resulting from central sensitization.
NGF is a neurotrophin known to play a critical role in the proper development of the nervous system. Evidence indicates that NGF is also involved in the increased pain experience of many individuals via peripheral sensitization of nociceptive neurons. Therefore, NGF levels have been shown to be elevated in a wide variety of chronic pain conditions including knee OA. Anti-NGF therapies are being highly studied as they have significant potential to decrease pain and improve function in individuals with OA that do not respond to conventional analgesics.
Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years of age and over
- •Have a diagnosis of knee OA by a physician
- •or fulfill the NICE criteria for knee OA diagnosis
- •Have an average pain intensity of ≥3/10 on a numeric pain scale
排除标准
- •Cannot communicate in English
- •Have inflammatory arthritis or other systemic conditions
- •Have had lower limb trauma
- •Had surgery within the past 6-month, have participated in a similar knee OA exercise program in the prior 3-months
- •Have used oral corticosteroids or had a corticosteroid injection in the index knee within 6-months prior to baseline assessment.
- •Does not have access to the internet
结局指标
主要结局
Acceptability of Content
时间窗: 8 weeks
A Likert scale out of 5 will assess how useful participants found the treatment. The minimum value is 1 and the maximum value is 5, with higher scores indicating a better outcome. The count of participants that reported the acceptability of content \>4/5 is reported and considered for proceeding with the study without protocol amendment.
Acceptability of Frequency
时间窗: 8 weeks
A Likert scale out of 5 will assess how acceptable participants found the frequency of the treatment. The minimum value is 1 and the maximum value is 5, with higher scores indicating a better outcome. The count of participants that reported the acceptability of frequency \>4/5 is reported and considered for proceeding with the study without protocol amendment.
Acceptability of Duration
时间窗: 8 weeks
A Likert scale out of 5 will assess how acceptable participants found the duration of the treatment. The minimum value is 1 and the maximum value is 5, with higher scores indicating a better outcome. The count of participants that reported the acceptability of duration \>4/5 is reported and considered for proceeding with the study without protocol amendment.
Burden of Questionnaires
时间窗: 8 weeks
A numeric rating scale out of 10 will assess how burdensome participants found completing the questionnaires. On this scale,1 represents no burden at all and 10 represents very much a burden. Higher scores indicate a worse outcome. There is no minimum or maximum value. The count of participants that reported the burden \<3/10 is reported and considered for proceeding with the study without protocol amendment
Burden of Physical Tests
时间窗: 8 weeks
A numeric rating scale out of 10 will assess how burdensome participants found completing the physical tests. On this scale,1 represents no burden at all and 10 represents very much a burden. Higher scores indicate a worse outcome. The count of participants that reported the burden \<3/10 is reported and considered for proceeding with the study without protocol amendment.
Recruitment Rate
时间窗: 8 weeks
Number of eligible participants who consent to participate in 1 month.
Follow-Up Rate
时间窗: 8 weeks
Percentage of participants who follow-up at 8 weeks.
Self Reported Adverse Events
时间窗: 8 weeks
Percentage of participants who did not experience any adverse events or only mild transient.
Exercise Completion
时间窗: 8 weeks
Percentage of participants who report exercising at least 3 times a week.
Adherence
时间窗: 8 weeks
Adherence to the program. This is the number of sessions that were attended by the participants. There are 2 sessions per week for 8 weeks, for a total of 16 sessions per participants. With 14 participants being in the study, the total number of sessions to be attended is 224. The number of sessions that were actually attended is being reported.
Recommending the Program
时间窗: 8 weeks
Likelihood of recommending the program to others. On a scale of 1 to 5, participants rate how likely they would recommend the program to other people. On this scale, 1 is the minimum, and 5 is the maximum, with higher scores indicating a better outcome. Participants that indicate a score of 4 or 5 are counted as the number of participants that would likely recommend the program to others (the number being reported).
Using the Treatment Again
时间窗: 8 weeks
Likelihood of using the treatment again. On a scale of 1 to 5, participants rate how likely they would use the treatment again. On this scale, 1 is the minimum, and 5 is the maximum, with higher scores indicating a better outcome. Participants that indicate a score of 4 or 5 are counted as the number of participants that would likely use it again (the number being reported).
次要结局
- Change in Function(8 weeks)
- Change in Brain-derived Neurotrophic Factor(8 weeks)
- Change in Pain Modulation(Baseline, 8 weeks)
- Change in Pain Intensity - Past 24 Hours(Baseline, 8 weeks)
- Change in Pain Catastrophizing(8 weeks)
- Change in Chronic Pain Self-efficacy(8 weeks)
- Change in Physical Performance Tests(8 weeks)
- Change in Anxiety and Depression(8 weeks)
- Change in Perspectives on Knee Replacement Surgery 1(8 weeks)
- Change in Perspectives on Knee Replacement Surgery 2(8 weeks)
- Change in Perspectives on Knee Replacement Surgery 3(8 weeks)
- Change in Pain(8 weeks)