Tailored Pain Guide (TPG) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score
研究概览
简要总结
This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for chronic low back pain. This research will try to understand how much an electronic, self-management website like PainGuide can help participants.
The study hypothesizes that tailored digital interventions (plus using PainGuide) will demonstrate greater improvement in pain interference.
详细描述
There was an amendment approved by the University of Michigan Medical School Institutional Review Board (AME00158411). This amendment included the following:
increased enrollment numbers, updated recruitment procedures including the Non-Pharma Program (NPP) Sub-Study, as well as changes in time frames.
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
- None
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 Lower Back pain (cLBP) defined by the National Institutes of Health (NIH) Task Force Report on Research Standards for Chronic Low Back Pain, (i.e., low back pain present at least six months, and present more than half of those days.)
- •Individuals must have a score of greater or equal to (≥) 60 on PROMIS Pain Interference.
- •Non-Pharma Sub-study:
- •Must be referred and currently on the waitlist for the NPP at the Back & Pain Center (BPC)
排除标准
- •Current cancer related pain
- •Diagnosis of autoimmune disease
- •Unable to speak, write or read English
- •Visual or hearing difficulties
- •Pregnancy or breastfeeding
- •Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.
研究组 & 干预措施
Structured and tailored PainGuide
干预措施: Structured and tailored PainGuide (Behavioral)
Standard PainGuide
干预措施: Standard PainGuide (Behavioral)
结局指标
主要结局
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score
时间窗: Baseline, Week 24
The PROMIS Pain Interference consists of 4-items that assess the degree to which pain interferes with various aspects of life. Items are scored on a 1 ("Not at all") to 5 ("Very much") scale with a range of 4 - 20. Higher scores indicate greater pain interference
次要结局
- Change in pain intensity based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0(Baseline, Week 24 (initial group), Week 52 (NPP group))
- Change in the physical function based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0(Baseline, Week 24 (initial group), Week 52 (NPP group))
- Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive function(Baseline, Week 24 (initial group), Week 52 (NPP group))
- Change in pain interference based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0(Baseline, Week 24 (initial group), Week 52 (NPP group))
- Change in anxiety based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0(Baseline, Week 24 (initial group), Week 52 (NPP group))
- Change in depression based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0(Baseline, Week 24 (initial group), Week 52 (NPP group))
- Change in fatigue based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0(Baseline, Week 24 (initial group), Week 52 (NPP group))
- Change in sleep disturbance based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0(Baseline, Week 24 (initial group), Week 52 (NPP group))
- Change in ability to participate in social roles and activities based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0(Baseline, Week 24 (initial group), Week 52 (NPP group))
- Change in pain interference based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 - between baseline and 52 weeks for NPP participants(Baseline, Week 52 (T5))
研究者
Daniel Clauw, MD
Professor of Anesthesiology
University of Michigan