Modeling of Inter-Individual Differences in Chronic Pain Using Holistic Measures of Pain Severity, Stress, Cognition, Body and Mind Awareness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Pain Interference With Function
研究概览
简要总结
SERENITY is a remote observational study designed to characterize inter-individual differences in chronic pain among adults with chronic low back pain and adults with spinal cord injury-related neuropathic pain.
Participants will complete baseline assessments and intensive longitudinal data collection using ecological momentary assessment surveys, brief cognitive tests, and passive Fitbit data collection. Ecological momentary assessment surveys will be completed 4 times per day for at least 3 weeks and will assess pain interference, pain intensity, stress, affect, sleep, body and mind awareness, agency, medication use, manual therapy frequency, and related factors.
The study will use Bayesian hierarchical modeling, clustering analyses, and causal discovery approaches to identify person-specific and group-level factors associated with pain interference.
详细描述
Chronic pain is heterogeneous, and individuals with similar pain diagnoses may experience different levels of pain interference and may have different factors contributing to pain-related disability. SERENITY is a remote observational study designed to characterize between-subject heterogeneity in adults with chronic low back pain and adults with spinal cord injury-related neuropathic pain.
The study will enroll 200 adults with chronic low back pain and 200 adults with spinal cord injury-related neuropathic pain. Participants will complete baseline demographic, clinical, pain, emotional functioning, physical functioning, and quality-of-life assessments. Participants will also complete ecological momentary assessment surveys 4 times per day for at least 3 weeks. These surveys will assess pain intensity, pain interference with function, positive and negative affect, stress, sleep, body and mind awareness, agency or perceived control over pain and life, medication dosage, manual therapy frequency, and brief cognitive test performance.
Fitbit data will be collected passively during the study period to measure sleep, physical activity, heart rate, heart rate variability, daily readiness, and stress management. The study will use intensive longitudinal data from ecological momentary assessment surveys and Fitbit measures to develop Bayesian hierarchical models, pain-profile clusters, and personal causal models.
The primary objective is to identify SERENITY measures associated with or causally related to pain interference within each pain group. The study will also examine heterogeneity in pain profiles and explore person-specific causal relationships between pain interference and measures of pain severity, stress, cognition, body and mind awareness, affect, and agency.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Chronic low back pain for more than 3 months, or complete or incomplete spinal cord injury for more than 1 year with spinal cord injury-related neuropathic pain
- •Medically stable
- •Pain severity of at least 4 out of 10 on the numeric pain rating scale over the past week
- •Fluent in English
- •Access to the internet and a computer, iPad, or smartphone; study equipment may be provided if needed
- •Currently on stable pain medication or manual therapy appointments as part of clinical care
排除标准
- •Cognitive impairment or communicative disability preventing the participant from following directions
- •Major medical complications
- •Pregnancy
- •Current active treatments that could potentially influence SERENITY outcomes, such as cognitive behavioral therapy or Qigong
- •Prisoners
- •Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- •Non-English speakers
- •Individuals unable to read
- •Employees of the researcher
- •Students of the researcher
- •Active members of the military or DoD personnel
研究组 & 干预措施
Adults With Chronic Low Back Pain
Adults with chronic low back pain for more than 3 months and pain severity of at least 4 out of 10 over the past week. Participants will complete baseline questionnaires, ecological momentary assessment surveys, brief cognitive tests, and passive Fitbit data collection.
Adults With SCI-Related Neuropathic Pain
Adults with complete or incomplete spinal cord injury of more than 1 year, medically stable, with spinal cord injury-related neuropathic pain and pain severity of at least 4 out of 10 over the past week. Participants will complete baseline questionnaires, ecological momentary assessment surveys, brief cognitive tests, and passive Fitbit data collection.
结局指标
主要结局
Pain Interference With Function
时间窗: Four times daily for at least 3 weeks
Pain interference with function will be assessed using a single ecological momentary assessment item: "How much is your low back pain/neuropathic pain affecting your daily life function?" Response options range from 0 to 4, with higher scores indicating worse pain interference with function. This is not a standardized scale and is administered via ecological momentary assessment to support causal discovery pathways. Unit: points
次要结局
- Pain, Enjoyment of Life and General Activity Scale Score(Baseline)
- Brief Pain Inventory Short Form Pain Severity Composite Score(Baseline)
- Brief Pain Inventory Short Form Pain Interference Composite Score(Baseline)
- Spinal Cord Injury Functional Index/Assistive Technology Score(Baseline)
- Roland-Morris Low Back Pain and Disability Questionnaire Score(Baseline)
- Patient Health Questionnaire-4 Score(Baseline)
- World Health Organization Quality of Life 2-Item Score(Baseline)
- Cognitive and Affective Mindfulness Scale-Revised Score(Baseline)
- Pain Resilience Scale Score(Baseline)
- Positive and Negative Affect Schedule Short Form - Positive Affectivity Score(Four times daily for at least 3 weeks)
- Positive and Negative Affect Schedule Short Form - Negative Affectivity Score(Four times daily for at least 3 weeks)
- EMA Relaxation Score(Four times daily for at least 3 weeks)
- EMA Energy Score(Four times daily for at least 3 weeks)
- EMA Control Score(Four times daily for at least 3 weeks)
- EMA Sleep Difficulty Score(Four times daily for at least 3 weeks)
- EMA Fear of Movement Score(Four times daily for at least 3 weeks)
- EMA Pain Intensity Score(Four times daily for at least 3 weeks)
- Time to Completion for EMA Number Sequencing Task(Four times daily for at least 3 weeks)
- Time to Completion for EMA Number-Letter Sequencing Task(Four times daily for at least 3 weeks)
- Percent Correct for EMA Spatial Working Memory Task(Four times daily for at least 3 weeks)
- Fitbit-Derived Sleep Duration(Throughout the study assessment period, at least 3 weeks)
- Fitbit-Derived Physical Activity(Throughout the study assessment period, at least 3 weeks)
- Fitbit-Derived Heart Rate(Throughout the study assessment period, at least 3 weeks)
- Fitbit-Derived Heart Rate Variability(Throughout the study assessment period, at least 3 weeks)
- Fitbit-Derived Daily Readiness Score(Throughout the study assessment period, at least 3 weeks)
- Fitbit-Derived Stress Management Score(Throughout the study assessment period, at least 3 weeks)