Group-based Mindfulness for Patients With Chronic Low Back Pain in the Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 2
- 主要终点
- Pain Intensity and Interference at Baseline, 8 Weeks, 6 Months (Primary Timepoint), & 12 Months: Pain, Enjoyment, General Activity (PEG) Score
研究概览
简要总结
The purpose of this pragmatic clinical trial (PCT) research is to determine whether a group-visit approach modeled on Mindfulness-Based Stress Reduction can improve function for persons with chronic low back pain. This will be done by an embedded PCT within the evidence-based "OPTIMUM" (Optimizing Pain Treatment In Medical settings Using Mindfulness) program.
详细描述
The research will be conducted with three health care system (HCS) sites: Boston Medical Center (BMC), MA, a safety net health system; University of Pittsburgh Medical Center (UPMC), Pittsburgh, PA, a large health system; and Piedmont Health Services, NC, a network of federally funded health centers in partnership with the University of North Carolina (UNC), Chapel Hill.
As per NIH protocol for the funding, the first 12 month (Phase 1) of this PCT will be a pilot to plan and test the group-based mindfulness program for chronic pain program in each of the three sites with 5 participants/site. Once completed the Phase 2 will be conducted to integrate and test the group-based mindfulness program compared to standard of care for patients with chronic low back pain (cLBP) in the primary care setting at each collaborating site.
Eligible consenting participants will be randomized to either: the primary care providers (PCP) usual care group, or the group with both PCP usual care and the 8 weeks mindfulness clinical pain group. Participants will be asked to complete baseline and follow-up surveys about pain, function, pain medicine use, mood and anxiety symptoms, and quality of life. The surveys will take up to an hour to complete.
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)
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
- •Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months
- •A score ≥ 3 on the Pain, Enjoyment of Life and General Activity (PEG)
- •Willing and able to provide online or telephone informed consent
- •Speak English as the intervention manual is currently written in English
排除标准
- •Do not meet the above inclusion criteria
- •Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
- •Pregnancy
- •Metastatic cancer
- •First-degree relatives (parents, siblings, child) of someone who has participated or is participating in the OPTIMUM study
- •Members of the same household
- •Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 12 or more months
结局指标
主要结局
Pain Intensity and Interference at Baseline, 8 Weeks, 6 Months (Primary Timepoint), & 12 Months: Pain, Enjoyment, General Activity (PEG) Score
时间窗: Baseline, 8 weeks, 6 months (primary timepoint), 12 months
The PEG (pain, enjoyment, general activity) composite score will be used to assess pain intensity and interference. The PEG is a 3 item score with potential responses of 0 to 10 with 10 being the most severe pain. The 3 PEG items referring to the past week are: average pain, how pain interfered with enjoyment of life, how pain interfered with general activity To compute the PEG score, add the responses to the questions above, then divide by three to get a final score out of 10.
次要结局
- Physical Function at Baseline, 8 Weeks, 6 Months, and 12 Months(Baseline, 8 weeks, 6 months, 12 months)
- Sleep Disturbance at Baseline, 8 Weeks, 6 Months, & 12 Months(Baseline, 8 weeks, 6 months, 12 months)
- Quality of Life at Baseline, 8 Weeks, 6 Months, & 12 Months(Baseline, 8 weeks, 6 months,12 months)
- Opioid Prescription Use at Baseline, 8 Weeks, 6 Months, and 12 Months(Baseline, 8 weeks, 6 months, 12 months)
- Mindfulness at Baseline, 8 Weeks, 6 Months, & 12 Months(Baseline, 8 weeks, 6 months,12 months)
- Mindfulness at 12 Months(12 months)
- Patient Impression of Change at 8 Weeks, 6 Months, & 12 Months(8 weeks, 6 months,12 months)
- Pain Catastrophizing at Baseline, 8 Weeks, 6 Months, & 12 Months(Baseline, 8 weeks, 6 months, 12 months)
- Tobacco, Alcohol, Prescription Medications, and Other Substance Use at Baseline and 12 Months(Baseline and 12 months)
- Comorbidity at Baseline(Baseline)
- Treatment Expectation at Baseline(Baseline)
- Telehealth Usability at Baseline and 8 Weeks(Baseline, 8 weeks)
- Anxiety at Baseline(Baseline)
- Depression at Baseline(Baseline)
- Sleep Duration at Baseline and 6 Months(Baseline, 6 months)
- Classes of Back Pain Medication(Baseline, 8 weeks, 6 months, 12 months)
- Amount of Opioid Pain Medication(Baseline, 8 weeks, 6 months, 12 months)
- Trauma at 8 Weeks(8 weeks)
- Chronic Overlapping Pain at 8 Weeks(8 weeks)
- Dietary Supplement and Natural Products Use at 1 Month(Once at any timepoint)
- Use of Healthcare Resources by Participants as Documented in the EHR(12 months)