Effect of ZILRETTA Versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- OARSI - 30-second chair standing test
研究概览
简要总结
The purpose of this study is to examine the pre, post, and follow up effects of a single ZILRETTA knee injection vs a single CELESTONE SOLUSPAN knee injection on physiological measure of self-reported quality of life, pain, physical function, and physical performance in individuals with osteoarthritis (OA) knee pain. The Primary Investigator (PI) will recruit 20 symptomatic knee OA patients for this study. Patients will be randomized into one of two treatment arms, Arm 1 (ZILRETTA injection) or Arm 2 (CELESTONE SOLUSPAN injection). Patients in Arm 1 will receive a single 5 mL IV injection of 32 mg ZILRETTA into the affected knee joint. Patients in Arm 2 will receive a 5ml IV injection of 6mg/ml CELESTONE SOLUSPAN into the affected knee joint. Each study arm will include 10 patients. All data will be collected prior to injection (baseline), as well as at 6-week (post 1) and 12-week follow-ups (post 2). Patients will blinded to treatment arm until after they complete their 12-week follow up.
详细描述
Individuals with knee osteoarthritis (OA) often experience pain and difficulty completing many everyday activities, such as walking or climbing stairs. It is a major cause of lost work time and a serious disability for many people. Although there is no cure for arthritis, there are many treatment options available to help manage pain and keep people active.
The ZILRETTA knee injection and CELESTONE knee injection are both FDA approved, extended-release corticosteroid, and are both common nonsurgical treatment options for patients with OA. Currently, there are no studies that have compared ZILRETTA and CELESTONE SOLUSPAN.
c. Aims Specific Aim 1: To determine the difference between intra-articular (IA) injection of Zilretta and intra-articular injection of Celestone in patients with knee OA improves physical performance (OARSI recommended physical performance measures).
Primary Hypothesis 1: Patients who receive knee IA injection of Zilretta or Celestone experience improved physical performance detectable at 6 weeks and 12 weeks.
Specific Aim 2: To determine the difference between IA injection of Zilretta and IA injection of Celestone in patients with knee OA improves physical function (KOOS-PF).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Investigator and participant were blinded to study arm until the end of thier final visit/phone call. Medical assistant prepping injections and CCRC were not blinded.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Triamcinolone acetonide extended-release injectable suspension. Single intra-articular extended-release injection of triamcinolone acetonide, to deliver 32 mg (5 mL). For intra-articular use only and should not be administered by the following routes: epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, subcutaneous.
干预措施: Triamcinolone acetonide extended-release injectable suspension (Drug)
Arm 2
Betamethasone sodium phosphate and betamethasone acetate Injectable Suspension, USP 6 mg per mL, 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate. When oral therapy is not feasible, the Injectable Suspension is indicated for intramuscular use only.
干预措施: Betamethasone sodium phosphate and betamethasone acetate Injectable Suspension (Drug)
结局指标
主要结局
OARSI - 30-second chair standing test
时间窗: 12 week (removed due to COVID)
The maximum number of chair stand repetitions possible in a 30 second period (2-4).
OARSI - 30-second Chair Stand
时间窗: 6 week (removed due to COVID)
The maximum number of chair stand repetitions possible in a 30 second period (2-4).
OARSI - stair ascent
时间窗: 12 week (removed due to COVID)
The time (in seconds) it takes to ascend and descend a flight of stairs (2-6). The number of stairs will depend on individual environmental situations. Where possible, the 9-step stair test with 20cm (8 inch) step height and handrail is recommended.
KOOS-PS (Physical Function Shortform)
时间窗: 12 week
Scoring: Never/none=0, Monthly/mild=1, Weekly/moderate=2, Daily/severe=3, Always/extreme=4. Calculate the mean score for the 11 items, and divide by the maximum possible score for each item (i.e. 4). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. Please use the formula provided below. 100 - \[(mean score PF1-PF11)/4 \*100\]
KOOS-Quality of life subscale (QoL)
时间窗: 12 week
The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
OARSI - 40m Fast Paced Walk
时间窗: 12 week (removed due to COVID)
A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft) (2).
Numerical Rating Scale (NRS)
时间窗: 12 week
patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
次要结局
未报告次要终点