The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Knee Pain
研究概览
简要总结
The goal of this clinical trial is to understand the patient and clinic visit characteristics that affect health outcomes for individuals with knee osteoarthritis (OA) pain using topical diclofenac gel. The main questions it aims to answer are:
- What baseline patient characteristics predict response to topical diclofenac?
- Does patient physiology during the study visit predict response to topical diclofenac?
- Do study visit characteristics predict response to topical diclofenac?
Participants will:
- attend 2 study visits to complete study questionnaires and have blood drawn
- apply topical diclofenac to their knee for 8 weeks
- complete biweekly questions about knee pain and diclofenac use between study visits
详细描述
220 older adults with symptomatic knee OA will attend a single research clinic visit (one of four different types of study visits) with a study clinician. The investigators will video record the visits and measure participant heart rate and skin conductance during the visit. Participants will complete baseline questionnaires immediately prior to the study visit. All participants will receive diclofenac gel (a topical over-the-counter non-steroidal anti-inflammatory drug [NSAID]), a guideline recommended treatment for knee OA-related pain at the end of the first study visit. Participants will identify an "index" knee (worst pain, right or left) that they will treat and follow during the study. Between study visit 1 and the 8-week follow-up visit, participants will receive an every other week text message asking them to report on pain and diclofenac use to better understand changes in pain over time. Final questionnaires will be completed at the second study visit at week 8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •English-speaking
- •50 years of age or older
- •Radiographically confirmed knee OA of K/L grade 2 or higher within the past 2 years
- •Knee pain at least 15 days/month.
- •Average worst daily pain 3/10 or higher over a two-week period.
排除标准
- •Medical contraindication to taking NSAIDs such as: history of coronary artery bypass graft, myocardial infarction, coronary artery stent placement, or stroke within the past 6 months; systolic heart failure with ejection fraction <45%; chronic kidney disease stage ≥4; severe gastrointestinal bleed or stomach ulcer within the past 6 months; current pregnancy; cirrhosis; currently taking blood thinners (aspirin 81 mg daily is okay); allergy to NSAIDs or aspirin; or any other medical contraindication to using topical NSAIDs.
- •Inflammatory arthritis
- •Partial or total knee replacement of the index knee
- •Recent therapeutic injection of the index knee (less than 12 weeks)
- •Planned knee/lower limb surgery during the two-month study period
- •Active cancer treatment not in remission or life expectancy less than 6 months
- •Inability to provide informed consent (e.g. dementia)
- •Current use of topical or oral NSAIDs more than 3 days per week.
- •Inability to receive text messages or emails to complete questionnaires between study visits.
- •Unable to follow the study protocol.
研究组 & 干预措施
Diclofenac
All study participants receiving topical diclofenac gel 1%. Participants will be instructed to apply 4 grams of the gel to the index knee at least once per day, and up to 4 times per day, for 8 weeks.
干预措施: Topical Diclofenac gel 1% (Drug)
结局指标
主要结局
Knee Pain
时间窗: 8 weeks
Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score from the index knee at 8 weeks. Score range 0-20. Higher scores signify worse pain.
Knee Function
时间窗: 8 weeks
Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function score from the index knee at 8 weeks. Score range 0-68. Higher scores signify worse function.
次要结局
- Global Impressions(30 minutes)
- Non-verbal Behaviors(30 minutes)
- Skin conductance index measure(30 minutes)
- Change in patient skin conductance response(30 minutes)
- Heart rate variability index measure(30 minutes)
- Change in patient RMSSD (root mean square of successive differences)(30 minutes)
研究者
Michelle Dossett
Associate Professor in Residence
University of California, Davis