Multiprofen-CC to Reduce Pain in Hand Arthritis (MRP-HAND): A Crossover Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This clinical trial aims to find out if using 1 gram of Multiprofen-CC cream on the hands three times a day for 4 weeks can help reduce pain in adults with hand osteoarthritis, compared to a placebo (a cream with no active medicine). The research team will also look at how Multiprofen-CC affects hand function, opioid use, and how patients feel about their overall improvement. In addition, the research team will keep track of any side effects.
Participants will:
- Use both Multiprofen-CC and a placebo (a cream with no active medicine) during the study, in a random order.
- Be asked to apply 1 gram of cream to their hands three times a day for 2 weeks, following the manufacturer's instructions.
- Attend a visit before starting the study, after 2 weeks, and after 6 weeks.
- Report any symptoms they experience during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •Adults (18+)
- •Have been diagnosed with hand osteoarthritis according to American College of Rheumatology criteria
- •Experience pain and/or loss of function in one or both hands that interferes with daily life
- •Provide informed consent
排除标准
- •Unable to consent
- •Unable or unwilling to follow study protocol
- •Known allergy or contraindication to any of the study drugs or their ingredients
- •Have open wounds/cuts and/or skin conditions on the hand area
- •Pregnant or breastfeeding
- •History of impaired kidney or liver function
- •Rheumatoid or other inflammatory arthropathy
- •Hand surgery within the past 6 months or planned within the study period.
- •Use daily opioids (other than short acting codeine) for a chronic pain condition other than hand arthritis
研究组 & 干预措施
Multiprofen-CC™
Multiprofen-CC™ [ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%)] Dose: 1.0g, 3 times per day for 2 weeks
干预措施: Multiprofen-CC™ plus standard treatment (Drug)
Placebo
The placebo is the base cream with no medicinal ingredients Dose: 1.0g, 3 times per day for 2 weeks
干预措施: Placebo plus standard treatment (Other)
结局指标
主要结局
Pain intensity
时间窗: baseline [week 0] and weeks 2, 4, and 6
Average pain intensity will be measured using a 0-10 Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Scores are collected before and after each treatment period. Higher scores indicate greater pain intensity and thus a worse outcome.
次要结局
- Pain interference(weeks 2, 4 and 6)
- Hand function(weeks 2, 4 and 6)
- Patients reported improvement(weeks 2, 4 and 6)
- Safety - adverse events(through study completion, an average of 6 weeks)
研究者
Carolyn Levis
Principal Investigator
St. Joseph's Healthcare Hamilton