Musculoskeletal Outcomes Using Tylenol/Ibuprofen vs. Oral Steroids in New Injuries
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Pain
研究概览
简要总结
In this pilot study, the investigators aim to compare two short-term pain relief methods administered over the course of 6 days in the setting of acute musculoskeletal (MSK) pain:
- Methylprednisolone((Medrol)dose pack- standard taper per dose pack instructions
- Standard of Care (SOC) which includes a combination of Acetaminophen (Tylenol)+Ibuprofen (Motrin)
The investigators are interested in studying pain relief regimens for acute injury of any body part among an adult orthopaedic urgent care population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Adults 18+
- •Able to answer survey questions in English
- •MSK pain > 3 on the VAS scale in any body part
- •Invited to participate by and enrolling clinician
排除标准
- •> 2 weeks from pain onset
- •Fractures
- •Active infections
- •Anaphylactic reaction to either medication (Oral Steroids, Ibuprofen, and/or Acetaminophen)
- •Currently taking anti-platelet agents (aspirin </= 100/mg a day, clopidogrel, etc.)
- •Chronic Kidney Disease Stage 3 or worse
- •Uncontrolled diabetes (A1C above 9)
- •Currently taking oral anti-coagulants
- •History of bleeding ulcer
- •Cirrhosis
- •Taking daily prednisone
- •Chronic pain syndrome
- •Chronic pain medication (gabapentin, Lyrica, narcotics, etc.)
- •Pregnant Patients
- •Worker's Compensation Patients
研究组 & 干预措施
Methylprednisolone
Arm 1 dosing scheme:
Day 1: 2 tabs (8mg) before breakfast, 1 tab (4mg) at lunch and dinner, 2 tabs (8mg) at bedtime (6 tabs total) Day 2: 1 tab (4mg) before breakfast, lunch and dinner and 2 tabs (8mg) at bedtime (5 tabs total) Day 3: 1 tab (4mg) before breakfast, lunch and dinner and 1 tab (4mg) at bedtime (4 tabs total) Day 4: 1 tab (4mg) before breakfast, lunch and dinner (3 tabs total) Day 5: 1 tab (4mg) before breakfast and at bedtime (2 tabs total) Day 6: 1 tab (4mg) before breakfast (1 tab total)
干预措施: Methylprednisolone 4Mg Tab (Drug)
Oral Acetaminophen and Ibuprofen
Arm 2 dosing scheme:
Day 1: day of consent: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol Extra- Strength (ES)(1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 2: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 3: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 4: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner Day 5: 3 tabs ibuprofen (600mg) at breakfast and 2 tabs Tylenol ES (1000mg) at bedtime Day 6: 3 tabs ibuprofen (600mg) at breakfast
干预措施: Acetaminophen 500Mg Tab (Drug)
Oral Acetaminophen and Ibuprofen
Arm 2 dosing scheme:
Day 1: day of consent: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol Extra- Strength (ES)(1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 2: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 3: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 4: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner Day 5: 3 tabs ibuprofen (600mg) at breakfast and 2 tabs Tylenol ES (1000mg) at bedtime Day 6: 3 tabs ibuprofen (600mg) at breakfast
干预措施: Ibuprofen 200Mg Oral Tablet (Drug)
结局指标
主要结局
Change in Pain
时间窗: 1 week, 1 month
Pain as self-reported by the patient, following pain medication treatment for an acute musculoskeletal (MSK) injury as measured with the Visual Analog Scale (VAS) where 0 is no pain at all and 10 is the worst pain imaginable. Lower scores indicate less pain.
次要结局
- Change in Function(1 week, 1 month)
研究者
Rajiv Jain
Rajiv Jain, MD
State University of New York at Buffalo