Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Change in Resting Pain Score at 3 Days (Effectiveness Outcome)
研究概览
简要总结
The purpose of this clinical trial is to compare the analgesic effects (relief of pain) of glucocorticoids (steroids) and pain medication versus pain medication alone in adult patients presenting to the emergency department with joint pain due to osteoarthritis. Steroids are drugs that can reduce inflammation and are used commonly for many different medical conditions.
In brief, the central aims of the study are to:
- Assess the efficacy of adding oral glucocorticoid medications to the standard pain medications used to treat the pain of osteoarthritis.
- Assess the safety and tolerability of oral glucocorticoid medication for the short-term treatment of osteoarthritis pain.
We hypothesize that: 1) The addition of glucocorticoids to standard pain medications will improve reported pain scores at 3 days following the initiation of treatment compared to standard pain medications alone and 2) The use of glucocorticoids will be well tolerated.
Participants in the study will be randomized (like flipping a coin) into one of three groups:
- Study Group 1 (Control) receiving placebo pills (no active ingredient) once a day for 5 days, plus ibuprofen (pain medication) for 5 days.
- Study Group 2 (Intervention A) who will receive prednisone (steroid) once a day for 5 days, plus ibuprofen (pain medication) for 5 days.
- Study Group 3 (Intervention B) who will receive one dose of dexamethasone (steroid) followed by placebo pills (no active ingredient) once a day for 4 days, plus ibuprofen (pain medication) for 5 days.
In all groups, acetaminophen (a different pain medication) can be taken as needed for pain that is not controlled with ibuprofen.
Participants will:
- Receive follow up phone calls at 1, 3, 7 and 14 days.
- Report pain scores related to joint pain.
- Report the number of pills taken of the various medications used in the study.
- Report any adverse events incurred during the follow up period.
详细描述
BACKGROUND
Osteoarthritis (OA) constitutes a significant disease burden both within the United States (US) and globally. Recent data shows that upwards of 527 million people worldwide were affected by OA in 2019. Data from 2001-2005 suggests that over 77 million ambulatory visits in the US were attributed to arthritic and rheumatological disorders, of which OA was the predominant etiology. Patients often present to the emergency department (ED) with complaints of acute pain related to OA.
Current guidelines recommend both lifestyle interventions and pharmacological interventions for the treatment of OA-related pain. Oral non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, ketorolac, and diclofenac remain first-line agents for the treatment of OA-related pain with strong recommendations for this intervention from the American College of Rheumatology/ Arthritis Foundation. In contrast, the evidence for topical NSAID use for the treatment of OA pain is inconsistent regarding their benefit.
Glucocorticosteroids, or glucocorticoids, are commonly used for their anti-inflammatory effects. Intraarticular glucocorticoid injections are a recommended adjunct treatment for OA-related pain refractory to NSAIDs. The majority of clinical practice guidelines support their use in OA with recent data showing significant improvement in pain scores following intraarticular glucocorticoid injections. Although commonly used in the outpatient setting, intraarticular injections for OA are used less frequently in the ED. This is due to the time required to perform the procedure, the need for subsequent follow-up, and technical considerations.
Compared to oral administration, intraarticular glucocorticoid injections have less systemic absorption and the potential for decreased adverse effects; however, oral glucocorticoid regimens have been shown to be well tolerated when given in short courses for acute pain. A Cochrane review examining short-term oral glucocorticoid use for the treatment of radicular low back pain found no association with significant adverse effects, including hyperglycemia.
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, 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
- •Age ≥18 years
- •Acute monoarticular arthritic joint pain affecting native knee, hip, or shoulder presumed to be related to osteoarthritis
- •Acute pain above baseline starting less than 72 hour prior to ED visit
- •Planned discharge from the ED
- •History of osteoarthritis of the affected joint based on radiography performed at index visit or prior available imaging
排除标准
- •Trauma to the affected joint within 30 days
- •Injection of affected joint within 60 days
- •Prior arthroplasty of the affected joint
- •History of coronary artery disease, severe gastrointestinal bleeding, gastric/peptic ulcer disease, chronic kidney disease with GFR less than 30, or platelet disorders (including von Willebrand disease, hemophilia, severe thrombocytopenia with platelets less than 50 k/mcL)
- •Joint pain suspected to be related to rheumatoid arthritis, gout, septic arthritis, or other non-osteoarthritis autoimmune/inflammatory/infectious arthritis
- •Chronic/baseline use of glucocorticoids (greater than 5 mg daily prednisone or equivalent within previous 7 days) or NSAIDs (daily use for more than 2 days prior to presentation)
- •Daily prescription opioid use or active opioid use disorder
- •Illicit drug use
- •Known allergy/intolerance to ibuprofen/NSAIDs, prednisone, dexamethasone, or other medication precluding ability to participate in one or more study arms
- •Other contraindications to ibuprofen/NSAIDs or glucocorticoids
- •Planned hospitalization from the ED
- •Pregnancy
- •Incarceration
- •Inability to provide informed consent
- •Other conditions that would preclude compliance with the study protocol and medication dosing
研究组 & 干预措施
Control - Placebo
Subjects assigned to the Control group will receive placebo once a day for 5 days, plus ibuprofen 600 mg every 8 hours for 5 days.
干预措施: Placebo (Drug)
Intervention B - Dexamethasone
Subjects assigned to the Intervention B group will receive a single dose of dexamethasone 10 mg, plus ibuprofen 600 mg every 8 hours for 5 days.
干预措施: Dexamethasone (Drug)
Intervention A - Prednisone
Subjects assigned to the Intervention A group will receive prednisone 50 mg once a day for 5 days, plus ibuprofen 600 mg every 8 hours for 5 days.
干预措施: Prednisone (Drug)
结局指标
主要结局
Change in Resting Pain Score at 3 Days (Effectiveness Outcome)
时间窗: 3 days (72 hours)
Change in resting pain score from baseline at time of randomization based on subject-reported numerical resting pain score (0-10) for pain in the affected joint obtained during the follow up phone call on Day 3.
Adverse Events (Safety Outcome)
时间窗: 28 days
Occurrence of adverse events reported during follow up phone calls on Day 1, 3, 7 and 14 or during chart review on Day 14 and 28, including: * Hyperglycemia requiring discontinuation of the study medication * Diabetic ketoacidosis or hospitalization for diabetes-related process * Bleeding events, including gastrointestinal bleeding (GIB) * Abdominal pain requiring discontinuation of the study medication * Worsening renal function requiring discontinuation of the study medication * Other adverse events necessitating discontinuation of study medication * Repeat visit to an emergency department * Hospitalization * Death
次要结局
- Change in Resting Pain Score at 1 Day(1 day (24 hours))
- Change in Resting Pain Score at 14 Days(14 days)
- Change in Resting Pain Score at 7 Days(7 days)
- Change in Ambulatory/Active Movement Pain Score at 1 Day(1 day (24 hours))
- Change in Ambulatory/Active Movement Pain Score at 3 Days(3 days (72 hours))
- Change in Ambulatory/Active Movement Pain Score at 7 Days(7 days)
- Change in Ambulatory/Active Movement Pain Score at 14 Days(14 days)
- Use of Rescue Medication for Pain (Acetaminophen)(14 days)