Exploring Non-pharmacological Approaches to Pain Management After Lumbar Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 267
- 试验地点
- 6
- 主要终点
- Pain, Enjoyment, and General Activity Scale (PEG-3)
研究概览
简要总结
This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the Military Health System (MHS). Effectiveness will be based on post-surgery patient-centered outcomes and extent of opioid use. The study design is a 2-arm, parallel group, individual-randomized trial.
详细描述
The relevance of our model is supported by evidence that pain catastrophizing, self-efficacy and hypervigilance predict poor surgical outcomes and long-term opioid use. Surgery can exacerbate catastrophic thinking, especially if patients have unrealistic recovery expectations that go unmet. Physical therapy (PT) can improve chronic LBP (low back pain) outcomes, with effects mediated through changes in pain catastrophizing and self-efficacy. Mindfulness techniques help patients disentangle an experience (e.g., pain) from associated emotions and appraisals. Mindfulness can enhance emotion regulation and raise un-conscious behavioral responses (e.g., opioid use) to conscious consideration. The benefits of mindfulness for chronic pain are mediated by changes in hypervigilance and self-efficacy. Physical therapy and mindfulness can disrupt the self-reinforcing cycle of pain, catastrophic appraisal and unconscious behavioral response including opioid use. Our project examines an innovative strategy to integrate mindfulness and PT into an enriched surgical management pathway for individuals undergoing lumbar spine surgery.
Patients at 3 different military hospitals will be randomized prior to surgery to two different treatment groups and followed for a period of 6 months, including the post-operative intervention phase.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Study participants and clinicians cannot be blinded to study treatments. Randomization assignment will not be revealed until after enrollment and completion of baseline assessments. Study statisticians cannot be blinded to participants' study treatment assignments because they must complete Data Safety Monitoring Reports and analyze the study outcomes by treatment group. Study investigators will remain blinded to participants' treatment group assignment. Follow-up assessments will be performed by a research assistant who will be blinded to participants' treatment group assignment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tricare beneficiary receiving care in a participating MHS facility.
- •Age 18 - 75 years at the time of enrollment
- •Scheduled to undergo lumbar spine surgery within the next 60 days. Surgery may be laminectomy with or without fusions including lateral, transforaminal, posterior or anterior approach for 1-4 lumbar levels. Surgery may be performed in military or civilian facility
- •Indication for surgery may include disc herniation, degenerative disc disease, lumbar stenosis, degenerative spondylolisthesis or scoliosis.
- •Anticipates ability to attend treatment sessions over a 16 week period following the surgical procedure with no planned absence of 2 weeks or more for training, vacation or any purpose
排除标准
- •Indication for surgery is infection, fracture, tumor, trauma or other indication requiring emergency surgery.
- •A microsurgical technique as the primary procedure, such as an isolated laminotomy or microdiscectomy
- •Surgical procedure is a revision or participant has undergone a lumbar surgical procedure in the past year.
- •Contra-indication to participation in post-operative exercise program including severe orthopedic injury limiting mobility, wheelchair dependency, neurological disorder impacting mobility, reliance on supplemental oxygen for daily activity, etc.
- •Pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
研究组 & 干预措施
Standard Care (SC)
Standard Post-Surgical Care utilizing opioids.
干预措施: Standard Care (SC) (Behavioral)
Enriched Surgical Management Pathway (EMP)
Enriched Surgical Management Pathway utilizing Physical Therapy and Mindfulness in addition to Standard Protocol.
干预措施: Enriched Pain Management Pathway (EPM) (Behavioral)
结局指标
主要结局
Pain, Enjoyment, and General Activity Scale (PEG-3)
时间窗: 6 Months
The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Response options for each item range from 0-10 with higher scores indicating higher pain intensity. The PEG-3 score is expressed as the mean of all item scores.
次要结局
- Time to Discontinuation of Opioids After Surgery(6 Months)
研究者
Dan Rhon
Director, Primary Care Musculoskeletal Research Center
Brooke Army Medical Center