Partners for Pain & Wellbeing: A Randomized Trial of Community Supported Complementary and Integrative Health Self Management for Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Pain, Interference with Enjoyment of Life and General Activity
研究概览
简要总结
The goal of this clinical trial is to learn how well two community-based self-management programs work in people with chronic back or neck pain. The main question it aims to answer is:
How well does a community-based self-management program teaching mind-body skills such as mindfulness and cognitive behavioral approaches (Partners4Pain) work for reducing pain intensity and interference with general activities and enjoyment of life compared to a community-based self-management program focused on general health and wellbeing (Keys to Wellbeing)?
Participants will be asked to do the following:
- Attend 2 screening visits to learn about the study and see if they meet the requirements to participate.
- Be randomly assigned to one of the two community-based self-management programs.
- Attend 9 weekly self-management program sessions (90 minutes each)
- Complete surveys about their pain and overall health at 2 months (after the programs end), 4 months, and 6 months.
Funding for the project is provided through the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Neurological Disorders and Stroke (NINDS) through the NIH HEAL Initiative (https://heal.nih.gov/), R33AT012309.
详细描述
This project is a full-scale, multi-level randomized hybrid effectiveness implementation trial (n=376) of 'Partners4Pain', a community supported self-management program for individuals with back or neck pain. Partners4Pain will be compared to an active control, Keys to Wellbeing. Both programs were optimized and feasibility tested in an earlier R61 pilot study of 51 individuals (NCT05786508).
Aims for the hybrid effectiveness implementation trial are:
AIM 1. To assess the relative effectiveness of Partners4Pain versus Keys to Wellbeing in terms of:
- Primary effectiveness outcomes of pain intensity and interference over 6 months using bi-monthly assessments.
- Secondary effectiveness outcomes of pain impact, self-efficacy and other HEAL outcomes.
AIM 2. To assess the impact of health factors on the effectiveness of Partners4Pain for primary and secondary outcomes through subgroup analyses which account for potential complexities between factors.
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
- •18 years of age or older
- •Self-reported chronic back pain (defined as pain in the low or mid back, or neck pain) which has lasted for 3 months or longer
- •Score of 3 or higher on the self-reported Pain, Enjoyment of Life and General Activity scale (PEG scale - 0-10)
- •Member of one or more of the following populations: American Indian/Alaska Native; Asian; Black/African American; Hispanic/Latino; Native Hawaiian/Pacific Islanders; Socioeconomically disadvantaged (annual household income less than $50,000)
- •Reside within the Minneapolis/St. Paul metro region
排除标准
- •Severe unmanaged mental illness
- •Self-reported cancer with active treatment involving radiation or chemotherapy.
- •Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion of cognitive impairment
- •Self-reported pregnancy
研究组 & 干预措施
Partners4Pain
Community-based program that focuses on evidence based mind-body tools (mindfulness, cognitive behavioral approaches) for pain self-management in addition to pain education and physical exercises.
干预措施: Partners4Pain (Behavioral)
Keys to Wellbeing
Community-based program that focuses on general health and well-being education for pain self-management in addition to pain education and physical exercises.
干预措施: Keys to Wellbeing (Behavioral)
结局指标
主要结局
Pain, Interference with Enjoyment of Life and General Activity
时间窗: Baseline, 2, 4, 6 months
Measured using the Pain, Enjoyment of Life and General Activity (PEG) scale that measures average pain intensity, interference with enjoyment of life, and interference with general activity in the past week. Each item is measured on a 0 (no pain/does not interfere) to 10 numeric rating scale (pain as bad as you can imagine/completely interferes).
次要结局
- Graded Chronic Pain Scale(Baseline, 2, 6 months)
- Self-efficacy for Managing Chronic Conditions(Baseline, 2, 4, 6 months)
- Domain Specific Life Satisfaction(Baseline, 2, 4, 6 months)
- Quality of Life and Health Satisfaction(Baseline, 2, 4, 6 months)
- Physical Functioning(Baseline, 2, 4, 6 months)
- Pain Catastrophizing(Baseline, 2, 4, 6 months)
- Interoceptive Awareness(Baseline, 2, 4, 6 months)
- Overall Improvement(Months 2, 4, 6)
- Intervention Satisfaction(Months 2, 4, 6)
- Social Isolation(Baseline, 2, 4, 6 months)
- Healthcare Use(Baseline, 2, 4, 6 months)
- Medication Use(Baseline, 2, 4, 6 months)
- Complementary Integrative Health Self-Management Use(Baseline, 2, 4, 6 months)
- Adverse Events(2, 4, 6, months)
- Sleep Disturbance(Baseline, 2, 6 months)
- Sleep Duration(Baseline, 2, 6 months)
- Anxiety(Baseline, 2, 6 months)
- Depression(Baseline, 2, 6 months)
- Participation in Social Roles and Activities(Baseline, 2, 6 months)
- Substance Use(Baseline, 2, 6 months)