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SERENITY Study of Chronic Pain Interference in Adults (SERENITY)

2026年11月2日 更新者：University of Minnesota

Modeling of Inter-Individual Differences in Chronic Pain Using Holistic Measures of Pain Severity, Stress, Cognition, Body and Mind Awareness

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.

研究概览

地位

尚未招聘

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

400

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Ann Van de Winckel, PhD, MSPT
  • 电话号码：6124062500
  • 邮箱：avandewi@umn.edu

学习地点

  • 美国
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota
        • 首席研究员：
          • Ann Van de Winckel, PhD, MSPT
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adults with chronic low back pain and adults with spinal cord injury-related neuropathic pain will be recruited nationwide for this remote observational study. Participants will be 18 years or older, medically stable, fluent in English, and have pain severity of at least 4 out of 10 over the past week. Participants will complete baseline assessments and intensive longitudinal data collection using ecological momentary assessment surveys, brief cognitive tests, and passive Fitbit data collection.

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Children
  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pain Interference With Function
大体时间：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
Four times daily for at least 3 weeks

次要结果测量

结果测量
措施说明
大体时间
Pain, Enjoyment of Life and General Activity Scale Score
大体时间：Baseline

Pain severity and impact will be assessed using the Pain, Enjoyment of Life and General Activity scale. This 3-item scale has a minimum score of 0 and maximum score of 30, with higher scores indicating worse pain severity and impact.

Unit: points
Baseline
Brief Pain Inventory Short Form Pain Severity Composite Score
大体时间：Baseline

Pain severity will be assessed using the Brief Pain Inventory Short Form 7-day recall. The pain severity composite includes 4 items, with scores ranging from 0 to 10. Higher scores indicate worse pain severity.

Unit: points
Baseline
Brief Pain Inventory Short Form Pain Interference Composite Score
大体时间：Baseline

Pain interference will be assessed using the Brief Pain Inventory Short Form 7-day recall. The pain interference composite includes 7 items, with scores ranging from 0 to 10. Higher scores indicate worse pain interference.

Unit: Points
Baseline
Spinal Cord Injury Functional Index/Assistive Technology Score
大体时间：Baseline

Physical functioning among participants with spinal cord injury will be assessed using the Spinal Cord Injury Functional Index/Assistive Technology measure. This 32-item measure has a minimum score of 0 and maximum score of 128, with higher scores indicating better physical functioning.

Unit: Points
Baseline
Roland-Morris Low Back Pain and Disability Questionnaire Score
大体时间：Baseline

Low back pain-related disability among participants with chronic low back pain will be assessed using the Roland-Morris Low Back Pain and Disability Questionnaire. This 24-item measure has a minimum score of 0 and maximum score of 24, with higher scores indicating worse disability.

Unit: Points
Baseline
Patient Health Questionnaire-4 Score
大体时间：Baseline

Depression and anxiety symptoms will be assessed using the Patient Health Questionnaire-4. This 4-item measure has a minimum score of 0 and maximum score of 12, with higher scores indicating worse depression and anxiety symptoms.

Unit: Points
Baseline
World Health Organization Quality of Life 2-Item Score
大体时间：Baseline

Quality of life and health satisfaction will be assessed using the World Health Organization Quality of Life 2-item measure. Each item is scored on a 5-point Likert scale. Total scores range from 2 to 10, with higher scores indicating better quality of life and health satisfaction.

Unit: Points
Baseline
Cognitive and Affective Mindfulness Scale-Revised Score
大体时间：Baseline

Mindful qualities will be assessed using the Cognitive and Affective Mindfulness Scale-Revised. This 12-item measure is scored from 1 to 4 per item. Total scores range from 1 to 48, with higher scores indicating better mindfulness-related qualities.

Unit: Points
Baseline
Pain Resilience Scale Score
大体时间：Baseline

Pain resilience will be assessed using the Pain Resilience Scale. This 14-item measure uses a 5-point Likert scale scored from 0 to 4 per item. Total scores range from 0 to 56, with higher scores indicating better positive adaptation to pain.

Unit: Points
Baseline
Positive and Negative Affect Schedule Short Form - Positive Affectivity Score
大体时间：Four times daily for at least 3 weeks

Positive affectivity will be assessed using the Positive and Negative Affect Schedule Short Form. Items are scored from 1 to 5. Total scores range from 5 to 25, with higher scores indicating better positive affectivity.

Unit: Points
Four times daily for at least 3 weeks
Positive and Negative Affect Schedule Short Form - Negative Affectivity Score
大体时间：Four times daily for at least 3 weeks

Negative affectivity will be assessed using the Positive and Negative Affect Schedule Short Form. Items are scored from 1 to 5. Total scores range from 5 to 25, with higher scores indicating worse negative affectivity.

Unit: Points
Four times daily for at least 3 weeks
EMA Relaxation Score
大体时间：Four times daily for at least 3 weeks

Relaxation will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating better relaxation.

Unit: points
Four times daily for at least 3 weeks
EMA Energy Score
大体时间：Four times daily for at least 3 weeks

Energy will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating better energy.

Unit: points
Four times daily for at least 3 weeks
EMA Control Score
大体时间：Four times daily for at least 3 weeks

Perceived control will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating better perceived control.

Unit: points
Four times daily for at least 3 weeks
EMA Sleep Difficulty Score
大体时间：Four times daily for at least 3 weeks

Sleep difficulty will be assessed using single ecological momentary assessment items related to trouble falling asleep, trouble staying asleep, and waking up too early. Each item will be scored separately from 0 to 4, with higher scores indicating worse sleep difficulty.

Unit: points
Four times daily for at least 3 weeks
EMA Fear of Movement Score
大体时间：Four times daily for at least 3 weeks

Fear of movement because of pain will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating worse fear of movement.

Unit: points
Four times daily for at least 3 weeks
EMA Pain Intensity Score
大体时间：Four times daily for at least 3 weeks

Pain intensity will be assessed using a single ecological momentary assessment item measuring pain intensity at the time of assessment. Scores range from 0 to 10, with higher scores indicating worse pain intensity.

Unit: points
Four times daily for at least 3 weeks
Time to Completion for EMA Number Sequencing Task
大体时间：Four times daily for at least 3 weeks

Attention will be assessed using a smartphone-based number sequencing task. Performance will be reported as time to completion.

Unit: Seconds
Four times daily for at least 3 weeks
Time to Completion for EMA Number-Letter Sequencing Task
大体时间：Four times daily for at least 3 weeks

Set-shifting will be assessed using a smartphone-based number-letter sequencing task. Performance will be reported as time to completion.

Unit: Seconds
Four times daily for at least 3 weeks
Percent Correct for EMA Spatial Working Memory Task
大体时间：Four times daily for at least 3 weeks

Spatial working memory will be assessed using a smartphone-based spatial working memory task. Performance will be reported as percent correct.

Unit: percent correct
Four times daily for at least 3 weeks
Fitbit-Derived Sleep Duration
大体时间：Throughout the study assessment period, at least 3 weeks

Sleep duration will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: hours
Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Physical Activity
大体时间：Throughout the study assessment period, at least 3 weeks

Physical activity will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: Steps
Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Heart Rate
大体时间：Throughout the study assessment period, at least 3 weeks

Heart rate will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: beats per minute
Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Heart Rate Variability
大体时间：Throughout the study assessment period, at least 3 weeks

Heart rate variability will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: milliseconds
Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Daily Readiness Score
大体时间：Throughout the study assessment period, at least 3 weeks

Daily readiness will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: points
Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Stress Management Score
大体时间：Throughout the study assessment period, at least 3 weeks

Stress management will be measured passively using Fitbit Charge 6 during the study assessment period.

Unit: points
Throughout the study assessment period, at least 3 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Minnesota

合作者

National Center for Complementary and Integrative Health (NCCIH)

调查人员

  • 首席研究员：Ann Van de Winckel, PhD, MSPT、University of Minnesota

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月21日

初级完成 (估计的)

2031年9月30日

研究完成 (估计的)

2031年9月30日

研究注册日期

首次提交

2026年9月2日

首先提交符合 QC 标准的

2026年9月9日

首次发布 (实际的)

2026年9月15日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PT-2026-35194
  • STUDY00029295 (其他标识符：University Of Minnesota)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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