Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
The purpose of this research is to learn more about treating Symptomatic Knee Osteoarthritis (OA) with an ultrasound-guided hypertonic dextrose injection. Researchers would like to determine best practice for injection frequency and effectiveness of the dextrose injection for symptomatic knee OA.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of knee OA by clinical criteria (American College of Rheumatology).
- •Identification of knee osteoarthritis by a radiologist on an existing knee radiograph obtained within 3 years of enrollment.
- •Moderate to severe knee pain for at least 3 months, defined as a score of ≥ 4 (on a 0-10 point numeric rating scale) in response to the question "What is the average level of your left/right knee pain in the past 3 months?".
排除标准
- •Pregnancy.
- •Diabetes.
- •Anticoagulation therapy.
- •History of total knee replacement.
- •Prior knee prolotherapy or other regenerative product.
- •Any knee injection within 3 months.
- •Inflammatory (RA, gout, pseudogout etc.) or postinfectious knee arthritis.
- •Daily use of opioid medication.
- •Allergy or intolerance to study medication, corn allergy.
- •Body mass index (BMI) greater than 40 kg/m^
- •Comorbidity severe enough to prevent participation in the study protocol.
- •Use of oral steroids during the study period
- •Use of injectable steroids in the past 3 months or during the study period
研究组 & 干预措施
Four injections of placebo
Subjects will receive four placebo intraarticular knee injections under ultrasound guidance. A placebo looks exactly like the study drug, but it contains no active ingredient.
干预措施: Placebo (Drug)
One injection of DPT and three injections of placebo
Subjects will receive one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.
干预措施: Placebo (Drug)
Two injections of DPT and two injections of placebo
Subjects will receive two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
干预措施: Placebo (Drug)
Two injections of DPT and two injections of placebo
Subjects will receive two intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by two intraarticular knee injections of placebo under ultrasound guidance.
干预措施: Dextrose prolotherapy (DPT) (Drug)
One injection of DPT and three injections of placebo
Subjects will receive one intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT), followed by three intraarticular knee injections of placebo under ultrasound guidance.
干预措施: Dextrose prolotherapy (DPT) (Drug)
Four injections of DPT
Subjects will receive four intraarticular knee injection under ultrasound guidance of dextrose prolotherapy (DPT).
干预措施: Dextrose prolotherapy (DPT) (Drug)
结局指标
主要结局
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) disease-specific tool used to measure physical function, pain, and stiffness in individuals with knee OA. Total scores range from 0-100, with higher scores indicating worse outcome.
次要结局
- Change in pain(Baseline, 4 weeks, 8 weeks, 16 weeks, 26 weeks, and 52 weeks)
研究者
David C. Patchett, DO
Principal Investigator
Mayo Clinic