A Double-blind, Randomized, Controlled, Equivalence Study Comparing Intra-articular Corticosteroid to Intra-articular Ketorolac Knee Injections
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 448
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
This study will compare the efficacy of intra-articular betamethasone injection to intra-articular ketorolac injection for symptomatic treatment of knee osteoarthritis in an equivalence study using a double-blinded, randomized, controlled design. Patients will be recruited from orthopaedic clinics at St. Luke's University Health Network. A total of 448 patients will be recruited (224 in each group) to receive an administration of an intra-articular betamethasone or ketorolac injection. The primary outcome is change in pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes include Knee Injury and Osteoarthritis Outcome (KOOS) and Knee Outcome Survey - Activities of Daily Living (KOS-ADL) scores and physical exam findings. Statistical analyses include repeated measures analysis of variance (ANOVA) (primary outcome) and selected ANOVA and nonparametric tests as deemed appropriate (secondary outcomes), with p < .05 denoting significance for all comparisons, and no adjustment for multiple testing.
详细描述
Introduction and Background
Min et al. performed a double blind study comparing triamcinolone to ketorolac in a total of 32 patients with subacromial impingement syndrome and found improved outcomes in University of California Los Angeles shoulder rating scale, improved active abduction, forward flexion strength and patient satisfaction scores. Shortcomings of this study included short-term follow up (4 weeks), lack of control of other forms of treatment of subacromial impingement including physical therapy and injection without ultrasound which limits the ability to determine the accuracy of injections. Many of the patients also had a lack of an MRI, thus being unable to determine if the patients had an undiagnosed rotator cuff tear or other pathology that may have influenced outcomes.
Karthikeyan et al. performed a similar trial analyzing tenoxicam (another non-steroidal anti-inflammatory medication) to methylprednisolone in 58 patients.Six weeks after injection, Constant-Murley shoulder scores, Disabilities of the Arm, Shoulder and Hand scores were significantly improved in the steroid group compared to tenoxicam injection.
Oztuna et al. randomized thirty patients with grade II to III osteoarthritis with an effusion to aspiration and oral tenoxicam for 10 days or aspiration and intra-articular tenoxicam. The patients were followed at 2, 4 and 8 weeks and then at 3 month intervals. Patients with intra-articular tenoxicam had significantly fewer effusions at 1 year and a more rapid relief in joint pain.
Unlu et al analyzed 69 patients with knee arthritis and compared weekly injections of tenoxicam for 3 weeks to PO tenoxicam for three weeks. They compared these two groups to patients who received only physical therapy. No significant difference was found between oral and intra-articular administration. Both oral and intra-articular tenoxicam had a significant improvement on knee pain
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Knee osteoarthritis as demonstrated on x-ray as Kellgren-Lawrence stage II or higher (Kellgren & Lawrence, 1957)
- •Clinical symptoms and physical exam consistent with osteoarthritis
排除标准
- •Prior treatment with corticosteroid injections within the last 1 year
- •Failure of past treatment with corticosteroid injections
- •Medical treatment including oral medication, physical therapy, or other analgesia use within the last 20 days prior to injection
- •Serious systemic disease
- •Gout arthropathy
- •Inflammatory joint disease including rheumatoid or psoriatic arthritis
- •Metabolic bone disease
- •Anserine bursitis or pain referred from other structures such as ipsilateral hip or lumbar spine
- •Patients with a significant effusion that requires aspiration
研究组 & 干预措施
Corticosteroid
This arm will receive intra-articular betamethasone.
4cc of 1% lidocaine, 1cc of 0.9% normal saline and 1cc (6 mg) of betamethasone.
An 18 gauge needle connected to a syringe filled with the study drug will be administered. If there is no effusion, a 22 gauge needle with 6cc of the study drug will be injected into the administration site
Please see detailed description of study for further information.
干预措施: Betamethasone (Drug)
Ketorolac
This arm will receive intra articular ketorolac.
2cc (60 mg) of ketorolac and 4cc of 1% lidocaine
An 18 gauge needle connected to a syringe filled with the study drug will be administered. If there is no effusion, a 22 gauge needle with 6cc of the study drug will be injected into the administration site
Please see detailed description of study for further information.
干预措施: Ketorolac (Drug)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Follow up at 1 month
Determination of patient's function and pain following intra-articular drug administration
次要结局
- Knee injury and Osteoarthritis Outcome Score score(Follow up at 1, 3 and 6 months)
- Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL) scale(Follow up at 1, 3 and 6 months)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Follow up at 6 months)
研究者
Paul Morton, MD
Orthopaedic Surgery Resident
St. Luke's Hospital, Pennsylvania