Rehabilitation With Empowered STrategies to Optimize REcovery After Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Pain Interference
研究概览
简要总结
The main goal of this clinical trial is to understand the benefits of remotely delivered Empowered Relief in patients undergoing lumbar spine surgery. The main question the trial aims to answer is:
Does a postoperative behavioral intervention, Empowered Relief, performed early after back surgery have a measurable impact on postoperative outcomes?
Additional questions are whether changes in pain catastrophizing are related to improvements in outcomes and whether preoperative pain catastrophizing is a moderator of response to treatment.
Researchers will compare remotely delivered Empowered Relief to remotely delivered education to see if Empowered Relief helps patients manage their pain and functional limitations after back surgery.
Participants will:
- Complete one group session of remotely delivered Empowered Relief or Education after back surgery
- Complete surveys before surgery and 3- and 6-months after surgery
详细描述
The proposed study will conduct a phase II, two-group randomized controlled trial in patients undergoing lumbar spine surgery. Patients will be enrolled and randomized prior to spine surgery from a civilian medical center and military treatment facilities. Patients will be randomized to either (1) 1-session Empowered Relief or (2) 1-session Education. Both interventions are delivered remotely in a group setting through a web-based platform by licensed health care professionals. Outcome assessments will be conducted by evaluators blinded to group assignment at 3-months and 6-months after surgery.The results of our clinical trial will advance research on remote nonpharmacologic strategies for managing pain and improving quality of life post-surgery in both civilian and military patient populations.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical treatment of a lumbar degenerative condition using a laminectomy and/or fusion procedure
- •English speaking
- •Age between 18-85 years
排除标准
- •Surgery due to trauma, fracture, tumor, infection, or spinal deformity
- •Revision surgery
- •Prior history of lumbar spine surgery in last 12 months
- •Involved in litigation or a workers' compensation claim due to injury
- •Currently undergoing treatment for cancer
- •Unable to access a reliable internet connection
- •Unable to provide a stable telephone or physical address
- •Unable to participate in follow-up assessment for 6 months after surgery
研究组 & 干预措施
Empowered Relief
Remotely delivered group session with behavioral strategies
干预措施: Empowered Relief (Behavioral)
Education
Remotely delivered group session with educational information
干预措施: Education (Other)
结局指标
主要结局
Pain Interference
时间窗: 3 and 6 months after hospital discharge
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (T-score metric), higher scores indicate greater pain interference
次要结局
- Pain Intensity(3 and 6 months after hospital discharge)
- Physical Function(3 and 6 months after hospital discharge)
- Disability(3 and 6 months after hospital discharge)
- Opioid Use(3 and 6 months after hospital discharge)
研究者
Kristin Archer
Professor
Vanderbilt University Medical Center