Prednisone for the Early Treatment of Complex Regional Pain Syndrome After Distal Radius Fracture - a Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Proportion of patient adherence to treatment allocation and protocol - determined by patient self-reporting
研究概览
简要总结
Wrist fractures are the most prevalent adult fracture. Complex regional pain syndrome (CRPS) is a common complication that can occur, leading to permanent disability and is costly to the patient and healthcare system. In addition, amidst the opioid epidemic, the risk of increased opioid use in patients with CRPS prompts the need to find viable treatment strategies. This study aims to evaluate an anti-inflammatory medication, prednisone, in the early treatment of CRPS. Patients with wrist fractures who undergo surgical treatment will be randomized to receiving placebo vs prednisone for 2 weeks. Clinical assessments in the follow up period will be compared.
详细描述
Purpose:
Distal radius fractures are the most prevalent adult fracture, accounting for 17.5% of all fractures. Complex regional pain syndrome (CRPS) is a common complication that can occur in this population, with a reported incidence of up to 32%. CRPS can lead to permanent disability and is costly to the patient and to the healthcare system, with an estimated cumulative outpatient and pain prescription cost of $42,026 over 8 years after diagnosis. In addition, amidst the opioid epidemic, the risk of increased opioid use in patients with CRPS prompts the need to find viable treatment strategies.
While there have been various proposed treatment modalities, evidence from randomized studies is lacking. Several small studies (retrospective and prospective case series) have shown potential efficacy of glucocorticoids for the treatment of CRPS. To our knowledge, there are no randomized controlled trials that evaluate treatment of CRPS in distal radius fractures with glucocorticoids.
The purpose of this pilot study is to evaluate a short course of oral prednisone as potential treatment for patients identified as developing early signs of CRPS after sustaining a distal radius fracture that was treated operatively. We will examine feasibility metrics including patient recruitment rate, adherence to allocation and protocol, withdrawal from study, and follow-through, in order to inform design of a definitive clinical trial. We will also assess the resolution of CRPS, post-operative opioid use, and any adverse events in patients who sustain a distal radius fracture after receiving prednisone vs placebo for 2 weeks post-operatively, with 6 months follow up post injury.
Hypothesis:
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is aged 19 years or older;
- •Patient has a unilateral, closed, distal radius fracture confirmed by radiographs;
- •The fracture is acute, within 21 days of injury;
- •Patient undergoes open reduction internal fixation with volar locking plate;
- •Patient is identified as at risk of developing CRPS with 2 or more of the following:
- •Pain score on visual analogue scale (VAS) greater than or equal to 5/10 within 1 week of injury and beyond;
- •Centre of Epidemiologic Studies Depression (CES-D) score on presentation is greater than or equal to 16;
- •Patient identifies as female;
- •Patient is identified as developing signs of CRPS based on the Budapest CRPS Criteria;
- •Patient provides informed consent.
排除标准
- •Patient has previously fractured ipsilateral wrist;
- •Patient has neurovascular injury associated with distal radius fracture;
- •Patient has associated extremity or polytrauma injuries that would interfere with rehabilitation and outcome measurements, in the opinion of the investigator;
- •Patient has allergy to prednisone or placebo ingredients;
- •Patient has contraindication to prednisone or placebo ingredients;
- •Patient already takes a glucocorticoid medication;
- •Patient has active bacterial, viral, or fungal infection;
- •Patient is diagnosed with diabetes;
- •Patient is pregnant, planning on becoming pregnant, or breastfeeding;
- •Patient is anticipated to have difficulty completing study follow up, in the opinion of the investigator.
研究组 & 干预措施
Placebo
placebo tablet PO once daily for 14 days starting day of surgery
干预措施: Placebo (Drug)
Prednisone
40 mg PO once daily for 14 days starting day of surgery
干预措施: Prednisone (Drug)
结局指标
主要结局
Proportion of patient adherence to treatment allocation and protocol - determined by patient self-reporting
时间窗: 6 months
Percentage of patients enrolled in the study who report to completing their 14-day course of treatment
Proportion of patients with missing data from secondary and tertiary outcomes
时间窗: 6 months
Percentage of enrolled patients who do not have complete secondary and tertiary outcome measures
Proportion of patient recruitment
时间窗: 6 months
Percentage of patients approached for recruitment who consent to study participation
Proportion of patient consent withdrawal from the study
时间窗: 6 months
Percentage of patients enrolled in the study who withdraw before completion of the study
Proportion of complete patient follow up at 6 months
时间窗: 6 months
Percentage of enrolled patients who complete all follow up visits
次要结局
- Adverse effects(2 weeks, 6 weeks, 3 months, 6 months)
- Resolution of CRPS(2 weeks, 6 weeks, 3 months, 6 months)
- Total opioid consumption(2 weeks)
研究者
David Stockton
Clinical Assistant Professor, Orthopaedic Trauma Surgeon
University of British Columbia