Low-Dose Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale (VAS) score
研究概览
简要总结
The purpose of this research is to compare low-dose radiotherapy to corticosteroid injection for treatment of hand/wrist osteoarthritis.
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
- 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
- •Patient at Mayo Clinic, Rochester, MN
- •Age 50 years or older
- •Mild, moderate, or severe hand OA (Kellgren and Lawrence classification grade 2, 3, or 4) on hand radiographs within the last 24 months
- •Hand OA pain with a minimum VAS score relating to hand pain of ≥40 (on a 100-point scale) when using the affected hand
- •Ability to complete study questionnaires
排除标准
- •History of previous surgery to the affected hand(s)
- •Autoimmune joint disease such as rheumatoid arthritis or psoriatic arthritis
- •Active confounding hand condition such as stenosing tenosynovitis or Dupuytren's contracture
- •Recent injury (within last 1 month) to the affected hand causing current pain
- •History of crystalline arthritis (gout or pseudogout) flare in the affected hand(s)
- •Active use of opioid pain medication(s) or oral steroids within the last 3 months
- •Fibromyalgia or central sensitization syndrome
- •Hand CSI or other hand injection within the past 3 months
- •History of hand LDRT within the past 3 months
- •Poorly controlled diabetes (HbA1c > 10%)
- •Active infection
- •Current pregnancy
研究组 & 干预措施
Corticosteroid injection (CSI)
Subjects will receive standard of care corticosteroid injection (CSI) therapy for hand osteoarthritis.
干预措施: Corticosteroid injection (CSI) (Drug)
Low-dose radiotherapy (LDRT)
Subjects will receive a total of six (6) low-dose radiotherapy (LDRT) treatments for hand osteoarthritis.
干预措施: Low-dose radiotherapy (LDRT) (Radiation)
结局指标
主要结局
Change in Visual Analog Scale (VAS) score
时间窗: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention
Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score.
次要结局
- Change in Cochin Hand Function Scale scores(Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention)
- Change in analgesic medication use(Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention)
- Patient experience, as measured by Was It Worth It questionnaire(6 months and 12 months post-intervention)
研究者
Terin T. Sytsma
Principal Investigator
Mayo Clinic