Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- American Shoulder and Elbow Score (ASES)
研究概览
简要总结
The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study. Investigators will compare the effectiveness of ketorolac compared to corticosteroid.
Specific Aim 1:
Hypothesis 1: Injection of the shoulder (in the subacromial space) with Ketorolac will be more effective than corticosteroid injection for the treatment of a variety of shoulder pathologies.
The risks associated with this study primarily concern adverse reactions to the study drugs. The drugs used in this study are not narcotics or habit-forming but can have side effects. The patient's physician will screen for any heart, intestinal, or kidney disease or condition that would increase the chance for the patient to have an unwanted side effect.
详细描述
The proposed study is a three arm, double-blinded, prospective randomized controlled clinical trial with follow-up immediately after the injection and at day 2, and weeks 1, 2, 4, 6, and 12. In this study investigators will compare the effectiveness of ketorolac compared to corticosteroid.
Subjects being seen for a rotator cuff injury will be randomized into one of three treatment groups pertaining to their pathology. The intervention will begin once the subject has consented and answered the Baseline Outcome Shoulder Questionnaire. The Baseline Outcome Questionnaire consists of the Visual Analog Score, American Shoulder and Elbow Score, Single Assessment Numeric Evaluation, Pittsburgh Sleep Quality Index, Short Form-12, and questions pertaining to patient characteristics, injury characteristics, co-morbidities, patient history, medications, and demographics.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Rotator Cuff Tendinitis
- •Atraumatic Rotator Cuff Tear
- •Rotator Cuff Tear Arthropathy
- •Subjects who speak English
排除标准
- •Age: < 18 years old
- •Prior Shoulder Surgery
- •Acute Traumatic Rotator Cuff Tear
- •Infection
- •Uncontrolled Diabetes Mellitus (HbA1c >8)
- •Recent Prior Shoulder Injection in either the Subacromial space
- •Workers Compensation
- •History of Gastric Ulcers
- •Tumor Involving the Shoulder Region
- •Prior history of gastrointestinal bleeding, allergic reactions, impaired renal function, seizures or cardiac arrhythmias
- •Subject unable to provide informed consent
- •Subjects who don't speak English
- •Patients who are pregnant or lactating at time of screening or are of child bearing age
- •Patients currently receiving an aspirin, NSAID regimen or any other anti-inflammatory agents that could affect inflammation response.
- •Patients with any bleeding disorders.
- •Patients with severe renal failure.
- •Patients likely to have severe problems maintaining follow-up, including patients diagnosed with severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.
- •Patients who are allergic to aspirin, ketorolac tromethamine and other NSAIDs
研究组 & 干预措施
Group 1 (control)
will receive an injection of 5 cc 0.25% Marcaine without epinephrine
干预措施: Marcaine (placebo) (Drug)
Group 2 (ketorolac)
will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
干预措施: Ketorolac (Drug)
Group 2 (ketorolac)
will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
干预措施: Marcaine (placebo) (Drug)
Group 3 (kenalog)
Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care
干预措施: Marcaine (placebo) (Drug)
Group 3 (kenalog)
Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care
干预措施: Kenalog (Drug)
结局指标
主要结局
American Shoulder and Elbow Score (ASES)
时间窗: Week 12
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome.
Visual Analog Scale
时间窗: Week 12
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
次要结局
- Single Assessment Numeric Evaluation (SANE)(Week 12)
- Short Form 12 (SF-12)(Week 12)
- Pittsburgh Sleep Quality Index (PSQI)(Week 12)
研究者
Michael Khazzam
PROFESSOR -Orthopaedic Surgery
University of Texas Southwestern Medical Center