Healing Track Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory Short Form
研究概览
简要总结
This is a randomized clinical trial to evaluate a digital pain reprocessing therapy (PRT) intervention for chronic back pain (CBP).
The purpose of this research is to test whether a new digital treatment for chronic pain works as well as traditional treatments for chronic back pain (CBP). Some people with CBP experienced side effects from other treatments, or previous treatments did not relieve pain, so this research aims to see if a digital therapy is a better option for CBP.
This study will assess changes in pain intensity from PRT intervention compared to a standard of care (SOC) control group in adults with CBP. SOC is defined as a comprehensive clinical care plan, including a consultation with physiatrist and prescribed interventions, which will capture a comparison representative of all potential interventions that are recommended for an individual.
The research team plans to enroll 180 participants who will be randomized into one of three groups.
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 (Outcomes Assessor)
盲法说明
The study team will remain unblinded for study procedures. Statistical analysis will be performed by a statistician who is blinded.
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21 to 70
- •Chronic Back Pain- CBP will be defined according to the criteria established by a recent NIH task force
- •Pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months.
- •Patients must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPISF) (on the item measuring average pain over the last week).
- •Participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner.
- •Able to use a smartphone
排除标准
- •Back pain associated with compensation or litigation issues as determined by self-report within the past year
- •Leg pain is greater than back pain, as this suggests neuropathic pain, which may be less responsive to psychotherapy
- •Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function
- •Self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder
- •Self-reported use of intravenous drugs, due to concerns about infections and subject compliance with experimental protocols
结局指标
主要结局
Brief Pain Inventory Short Form
时间窗: <Day 0, Day 0, Day 1, Week 6, Week 10, Month 8.5
A 9-item instrument with total score from 0 to 10, with higher score indicating worse outcomes. Full scale from 0 to 10, with higher score indicating more pain symptoms. Minimum score: 0 (no pain) Maximum score: 10 (pain as bad as you can imagine)
次要结局
未报告次要终点
研究者
David Putrino
Professor
Icahn School of Medicine at Mount Sinai