Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,087
- 试验地点
- 16
- 主要终点
- Spine-related Cost of Care at One Year
研究概览
简要总结
Low back and neck pain are among the leading causes of medical visits, lost productivity and disability. There is an urgent need to identify effective and efficient ways of helping subjects with acute spine pain while guiding practitioners towards high-value care. This trial will be a block and cluster-randomized open-label multi-centered pragmatic randomized clinical trial comparing healthcare spending and clinical outcomes for subjects with spine pain of less than three months' duration, in whom there are no red flag signs or symptoms. Subjects will be randomized to one of three treatment strategies: (1) usual primary care provider-led care; (2) usual PCP-led care with spine pain treatment directed by the Identify, Coordinate, and Enhanced decision making (ICE) care model, and (3) usual PCP-led care with spine pain treatment directed by the Individualized Postural Therapy (IPT) care model. Our outcomes of interest will be spine-related healthcare utilization at one year as well as pain and functionality of the study participants.
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
- Single (Investigator)
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
- •Patients with back or neck pain of ≤ 3 months' duration. All patients must have spine pain with or without radiation to the extremities or the head
- •Age ≥ 18 years
- •Willing and able to provide informed consent
排除标准
- •Patients with symptoms attributed to the spine but without actual pain in the spine (e.g. those with cervicogenic headache without neck pain)
- •Currently pregnant
- •Currently receiving disability benefits, worker's compensation, or involved in litigation for a workplace injury
- •Currently enrolled in another intervention trial for the management of acute back or neck pain
- •Cancer that is metastatic or being actively treated. (i.e chemotherapy, radiation, surgery)
- •History of receiving active therapy for back or neck pain in the past 3 months (7+ consecutive days of narcotic use, 6+ sessions of PT, chiropractic care, acupuncture, postural therapy, or other spine therapy delivered by a trained provider)
- •History of spine surgery or spine injections/ablation in the past 6 months
- •Severe, active psychosis or major depression inhibiting ability to physically participate in intervention
- •Red Flag Symptoms (fever, night sweats, unintentional weight loss, bowel or bladder dysfunction, neurologic weakness, history of intravenous drug use)
结局指标
主要结局
Spine-related Cost of Care at One Year
时间窗: One year
Measured by patient self-report
Change in Pain
时间窗: Three months
Measured by Oswestry Disability Index The Oswestry Disability Index (ODI) captures pain related disability based on patient self-report. The ODI ranges from 0 (best) to 100 (worst). The Minimal clinically important difference (MCID) for ODI in patients with spine pain is 6 points. The change in participant-level pain related disability from baseline to 3 months using the Oswestry Disability Index has been reported. Reference: Fairbank JCT, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271-273
次要结局
- Self-efficacy(One year)
- Change in Pain(One year)
- Quality of Life (EQ5D-5L VAS Scores)(One year)
- Self-efficacy(One year)
研究者
Niteesh K. Choudhry, MD, PhD
Principal Investigator
Brigham and Women's Hospital