A Pragmatic, Randomized Controlled Trial of a Auricular Point Acupressure - Self-Management (APA-SM) Program for Chronic Musculoskeletal Pain Among Rural Populations.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 693
- 试验地点
- 6
- 主要终点
- Change in pain as assessed by the pain, enjoyment of life, general activity (PEG) survey
研究概览
简要总结
The investigators will test an Auricular Point Acupressure Self-Management (APA-SM) program integrated into rural primary and specialty care and rural communities for chronic musculoskeletal pain (CMP). To maximize self-management of pain, the investigators developed a smartphone app which will allow the participants to learn to self-administer APA. The investigators will have 3 arms (APA-SM self-guided with remote training, APA-SM with in-person training, and Education Control) with 231 participants per arm (total=693 for 3 arms). The investigators will evaluate the clinical effectiveness of our 4-week APA-SM intervention compared to control in primary outcomes (pain intensity, pain interference, activity), secondary outcomes (HEAL Clinical Pain Core common data elements), and analgesic use up to 6 months follow-up.
详细描述
The investigators integrated ecological momentary assessment into our app to measure real-world outcomes resulting in participants being able to self-monitor their progress, using this as an innovative behavior change strategy based on Bandura's self-efficacy, successfully initiating and maintaining behavior change. The primary endpoint will be immediate post-intervention with secondary endpoints at 1-month, 3-month, and 6-month follow-ups after the intervention. The investigators will also evaluate implementation outcomes and cost-effectiveness. Our long-term goal is to increase the access and scalability of evidence-based interventions while addressing pain care disparities for rural individuals with limited resources and/or endure long distances to specialty pain care. Study recruitment will be 3 1/2 to 4 years followed by data analysis.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receive any pain management for CMP (neck, back, shoulder, hands, hips, knees, feet)
- •Have CMP ≥ 4 on a scale of 0-10 that has persisted for at least 3 months or has resulted in pain on at least half the days in the past 6 months
排除标准
- •Severe ear skin disorder (Diagnosed with conditions e.g., eczema, lupus with skin involvement) which often require medical intervention and severe allergy to tape
- •Inability or unwillingness to provide informed consent
- •Use of some type of hearing aid where size may obstruct seed placement
- •Not living in rural area
结局指标
主要结局
Change in pain as assessed by the pain, enjoyment of life, general activity (PEG) survey
时间窗: Baseline, post intervention (4 weeks after baseline), 1 month, 3 months, 6 months
This is a three-item questionnaire and each is scored from 0 (no pain) to 10(worst pain) for a maximum score of 30. Higher score indicating worse outcome
次要结局
- Change in pain as assessed by the Pain Catastrophizing Scale (PCS6)(Baseline, post intervention (4 weeks after baseline))
- Change in fear-avoidance beliefs as assessed by the Fear-Avoidance Beliefs Questionnaire (FABQ)(Baseline, post intervention (4 weeks after baseline))
- Change in depression as assessed by the Patient Health Questionnaire (PHQ2 )(Baseline, post intervention (4 weeks after baseline))
- Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD2)(Baseline, post intervention (4 weeks after baseline))
- Change in severity of pain and its impact on functioning as assessed by the Brief Pain Inventory (BPI) Short From(Baseline, post intervention (4 weeks after baseline))
- Change in physical function as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 6b (SF6b)(Baseline, post intervention (4 weeks after baseline))
- Change in disability as assessed by the Roland Morris Disability Questionnaire (RMDQ)(Baseline, post intervention (4 weeks after baseline))
- Change in sleep duration as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep 6a (+Sleep Duration)(Baseline, post intervention (4 weeks after baseline))
- Change in pain self-efficacy influenced by pain as assessed by the Pain Self-Efficacy Questionnaire 2 item Short Form (PSEQ2)(Baseline, post intervention (4 weeks after baseline))
- Change in substance use as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance (TAPS1) Substance Use Screener(Baseline, post intervention (4 weeks after baseline))
- Change in quality of life as assessed by the World Health Organization Quality of Life 2 item (WHOQOL-2)(Baseline, post intervention(4 weeks after baseline))
- Change in positive outlook as assessed by the Healing Encounters and Attitudes Lists (HEAL)(Baseline, post intervention(4 weeks after baseline))
- Change in treatment expectancy as assessed by the Healing Encounters and Attitudes Lists (HEAL)(Baseline, post intervention(4 weeks after baseline))
- Change in attitude towards complement alternative medicine (CAM) as assessed by the Healing Encounters and Attitudes Lists (HEAL)(Baseline, post intervention (4 weeks after baseline))
- Change in analgesics and opioid use as assessed by the Ecological Momentary Assessment (EMA) diary(Baseline, post intervention (4 weeks after baseline))
研究者
Jennifer Kawi
Distinguished Professor
The University of Texas Health Science Center, Houston