Preventing Chronic Post-Surgical Pain and Prolonged Opioid Use: The Perioperative Pain Self-Management Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 4
- 主要终点
- Numeric Pain Rating Scale
研究概览
简要总结
This study will trial the impact of teaching surgical patients a pain self-management approach to compliment medical post-surgical pain management.
详细描述
Surgery can precipitate the development of both chronic pain and long-term opioid use. There is a need for strategies to augment perioperative pharmacotherapeutic management of pain with non-pharmacologic strategies to prevent long-term sequelae. Psychological interventions such as cognitive behavioral therapy (CBT) can effectively reduce distress and improve functioning among patients with chronic pain. While CBT has been used extensively in patients with established chronic pain, it has not been used as a preventive intervention targeting the transition from acute to chronic postsurgical pain. The Perioperative Pain Self-management (PePS) program has the potential to reduce the incidence of chronic post-surgical pain and long-term opioid use among Veterans. This study will: Examine the efficacy of PePS compared to standard care on 6-month pain (primary outcome), mood and functioning outcomes as well as time to post-surgical opioid and other analgesic use cessation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to randomization status.
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for total hip, knee, or shoulder joint arthroplasty through the Iowa City, IA, Des Moines, IA, Minneapolis, IA, or Milwaukee WI, VA medical centers
排除标准
- •inability to complete study forms/procedures because of a language/literacy barrier
- •active bipolar or psychotic disorder
- •history of brain injury
- •CBT therapy within the past year
- •lack of access to a telephone for PePS sessions
研究组 & 干预措施
PePS
4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care.
干预措施: Perioperative Pain Self-management (PePS) (Behavioral)
Standard Care
Standard perioperative care.
结局指标
主要结局
Numeric Pain Rating Scale
时间窗: 6-months post-surgery
Surgical Site Pain The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain.
次要结局
- opioid use(time to cessation post surgery (weekly phone calls for the first 6 weeks))
