Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Pain, Enjoyment, General activity (PEG) composite score
研究概览
简要总结
This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction. This will help enhance clinician decision-making and the targeted treatment of chronic pain.
The overall objective is to use a unique machine learning (ML) approach to determine the biomarker signature of persons undergoing mindfulness based stress reduction (MBSR) treatment for their chronic low back pain (cLBP). This signature will facilitate clinical prediction and monitoring of patient response to MBSR treatment.
The design of the study is a single-arm clinical trial of the evidence-based MBSR program for patients with cLBP.
详细描述
UG3 Phase Overview. The first 24-months of the project will be dedicated to performing machine learning modeling to identify candidate predictive and monitoring markers of cLBP response to MBSR, prior to the full clinical trial in the UH3 phase. We will also refine our procedures such as recruitment and outcomes assessment with 50 persons during the UG3 phase.
UH3 Phase Overview. Biopsychosocial markers will be identified of the response of diverse cLBP patients to MBSR (N=300) from comprehensive pain assessment and biopsychosocial data, including pain intensity and pain interference, physical activity, sleep, and heart rate for a 6-month period. Data will be collected and used for training and testing ML models. The MBSR program is evidence-based and meets weekly in a group via Zoom for 8-weeks for 90 minutes per week. Measures to determine biomarkers will be obtained at baseline (T1), four-weeks (T2), program completion (T3), four months (T4), and six months (T5). The main outcome timepoint with be at six months (T5), which allows time for durability of effects to be determined. The PEG (Pain, Enjoyment, General activity), obtained through online self-report surveys is the main outcome measure. Secondary outcomes of physical and psychological function will be self-report and obtained online, or if the patient prefers, by telephone, and physical activity, sleep, and heart rate variability will be collected by Fitbit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months
- •Willing and able to provide online or telephone informed consent
- •Speak English as the intervention manual is currently written in English
排除标准
- •Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
- •Pregnancy
- •Metastatic cancer
- •Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 6 or more months
研究组 & 干预措施
Mindfulness based stress reduction (MBSR) program
Participants will be enrolled in a 8-week mindfulness clinical pain program + Primary Care Provider (PCP) Usual Care.
干预措施: Mindfulness meditation (Behavioral)
Mindfulness based stress reduction (MBSR) program
Participants will be enrolled in a 8-week mindfulness clinical pain program + Primary Care Provider (PCP) Usual Care.
干预措施: Perspectives on pain (Other)
Mindfulness based stress reduction (MBSR) program
Participants will be enrolled in a 8-week mindfulness clinical pain program + Primary Care Provider (PCP) Usual Care.
干预措施: Discussion (Other)
结局指标
主要结局
Pain, Enjoyment, General activity (PEG) composite score
时间窗: 6 months
The PEG is a 3-question scale: "pain average", "interference with general activity" and "interference with enjoyment of life". Each question is on a 0-10 scale, and total PEG is the average. Scores can range from 0-30 and \<12=Mild,12 to \<21 = Moderate, 21 to 30 = Severe chronic pain.
次要结局
- Catastrophizing assessed by the Pain Catastrophizing Scale Short Form(baseline, 4 weeks, 8 weeks, 4 months, 6 months)
- Sleep disturbance assessed by the PROMIS Sleep Disturbance-Short Form 6a(baseline, 4 weeks, 8 weeks, 4 months, 6 months)
- Treatment components and effects assessed by the Healing Encounters and Attitudes List-Expectation(baseline, 4 weeks, 8 weeks, 4 months, 6 months)
- Pain Self-Efficacy assessed by the Pain Self-Efficacy Questionnaire(baseline, 4 weeks, 8 weeks, 4 months, 6 months)
- Quality of Life assessed by the Patient Reported Outcomes Measurement Information System (PROMIS 29)(baseline, 4 weeks, 8 weeks, 4 months, 6 months)
- Participants' Impression of change(baseline, 4 weeks, 8 weeks, 4 months, 6 months)
- Anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7)(baseline, 4 weeks, 8 weeks, 4 months, 6 months)
- Depression assessed by the eight-item Patient Health Questionnaire for Depression (PHQ-8)(baseline, 4 weeks, 8 weeks, 4 months, 6 months)
- Mindfulness assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)(baseline, 4 weeks, 8 weeks, 4 months, 6 months)
- Pain-Sleep Duration(baseline, 4 weeks, 8 weeks, 4 months, 6 months)
- Social support assessed by the Social Network Index(baseline, 4 weeks, 8 weeks, 4 months, 6 months)