Effects of Corticosteroid Injection Plus Reparel™ Knee Sleeve on Knee Osteoarthritis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks
研究概览
简要总结
The goals of treating knee osteoarthritis (OA) is to improve or maintain quality of life, mobility and function, pain relief, and improve inflammation. The different treatment options for knee OA have been extensively studied and implemented, but the optimum treatment is still undecided. There is a belief that anti-inflammatory sleeve technology may be beneficial in treating knee OA. The purpose of this study is to determine if the Reparel™ knee sleeve results in superior mobility, functionality, and pain outcomes as compared to a placebo knee sleeve in managing knee OA.
详细描述
Patients who are recommended non-operative management of their knee osteoarthritis and have consented to participate in the study will be randomized into two groups to receive either of the following
- Reparel knee sleeve
- Placebo knee sleeve
Participants assigned to both groups will be given instructions on how to use/wear the sleeve while performing activities of daily living or sports that had previously resulted in knee pain and also be asked to do the follows:
- Wear the sleeve as much as they possibly can
- Not change their usual activities and diet during the time they are on this study.
- Record in a diary the number of hours sleeve was worn per day
- Record any adverse effects or discomfort due to sleeve use.
- Not to receive any injections in the subsequent 6 months following baseline randomization visit.
Participant background information that is relevant to this study will also be collected from their medical record including age, sex, and race and stored in a hospital secure computer database (REDCap).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Unmarked sleeves will be used. Half will be Reparel sleeves, and half will be placebo. Participants and sleeve numbers will be randomized via REDCap.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoarthritis visible on knee radiograph
- •patient opting for non-surgical treatment
排除标准
- •bilateral symptomatic knee osteoarthritis
- •prior surgery on the knee of interest
- •hardware present on the knee of interest
- •gross instability detected on physical exam
- •malignancy in the knee of question
研究组 & 干预措施
Reparel Sleeve Group
Reparel sleeve and corticosteroid injection
干预措施: Reparel knee sleeve (Device)
Reparel Sleeve Group
Reparel sleeve and corticosteroid injection
干预措施: Corticosteroid injection (Drug)
Placebo Sleeve Group
Placebo sleeve and corticosteroid injection
干预措施: Corticosteroid injection (Drug)
Placebo Sleeve Group
Placebo sleeve and corticosteroid injection
干预措施: Placebo knee sleeve (Device)
结局指标
主要结局
Change in University of California, Los Angeles (UCLA) Activity Score at 4 weeks
时间窗: 4 weeks (T1)
activity score, 1-10, 10 is best outcome
Change in University of California, Los Angeles (UCLA) Activity Score at 3 months
时间窗: 3 months (T2)
activity score, 1-10, 10 is best outcome
Change in Lysholm Score at 3 months
时间窗: 3 months (T2)
ability to manage activities of daily living, 0-100, 100 is best outcome
Change in Visual Analog Scale (VAS) at 3 months
时间窗: 3 months (T2)
pain score, 0-10, 10 is best outcome
Change in University of California, Los Angeles (UCLA) Activity Score at 6 months
时间窗: 6 months (T3)
activity score, 1-10, 10 is best outcome
Change in Lysholm Score at 4 weeks
时间窗: 4 weeks (T1)
ability to manage activities of daily living, 0-100, 100 is best outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months
时间窗: 3 months (T2)
knee pain and function score, 0-100, 100 is best outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months
时间窗: 6 months (T3)
knee pain and function score, 0-100, 100 is best outcome
Change in Visual Analog Scale (VAS) at 6 months
时间窗: 6 months (T3)
pain score, 0-10, 10 is best outcome
Change in Oxford Knee Score (OKS) at 4 weeks
时间窗: 4 weeks (T1)
knee pain and function score, 0-48, 48 is best outcome
Change in Single Assessment Numeric Evaluation (SANE) at 6 months
时间窗: 6 months (T3)
function score, 0-100%, 100% is best outcome
Change in Oxford Knee Score (OKS) at 6 months
时间窗: 6 months (T3)
knee pain and function score, 0-48, 48 is best outcome
Change in Single Assessment Numeric Evaluation (SANE) at 4 weeks
时间窗: 4 weeks (T1)
function score, 0-100%, 100% is best outcome
Change in Lysholm Score at 6 months
时间窗: 6 months (T3)
ability to manage activities of daily living, 0-100, 100 is best outcome
Change in Oxford Knee Score (OKS) at 3 months
时间窗: 3 months (T2)
knee pain and function score, 0-48, 48 is best outcome
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 4 weeks
时间窗: 4 weeks (T1)
knee pain and function score, 0-100, 100 is best outcome
Change in Single Assessment Numeric Evaluation (SANE) at 3 months
时间窗: 3 months (T2)
function score, 0-100%, 100% is best outcome
Change in Visual Analog Scale (VAS) at 4 weeks
时间窗: 4 weeks (T1)
pain score, 0-10, 10 is best outcome
次要结局
- Average wear time of sleeve over past week at 6 months(6 months (T3))
- Average wear time of sleeve over past week at 4 weeks(4 weeks (T1))
- Satisfaction with knee sleeve at 6 months(6 months (T3))
- Average wear time of sleeve over past week at 3 months(3 months (T2))
- Satisfaction with knee sleeve at 4 weeks(4 weeks (T1))
- Satisfaction with knee sleeve at 3 months(3 months (T2))
研究者
Amit Momaya
Assistant Professor, Section Chief, Sports Medicine
University of Alabama at Birmingham