이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

SERENITY Study of Chronic Pain Interference in Adults (SERENITY)

2026년 9월 9일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

400

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Ann Van de Winckel, PhD, MSPT
  • 전화번호: 612-406-2500
  • 이메일: avandewi@umn.edu

연구 장소

  • 미국
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55455
        • University of Minnesota
        • 연락하다:
          • Ann Van de Winckel, PhD, MSPT
          • 전화번호: 612-406-2500
          • 이메일: avandewi@umn.edu
        • 수석 연구원:
          • Ann Van de Winckel, PhD, MSPT

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pain Interference With Function
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Pain, Enjoyment of Life and General Activity Scale Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Minnesota

협력자

National Center for Complementary and Integrative Health (NCCIH)

수사관

  • 수석 연구원: Ann Van de Winckel, PhD, MSPT, University of Minnesota

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2031년 9월 30일

연구 완료 (추정된)

2031년 9월 30일

연구 등록 날짜

최초 제출

2026년 9월 2일

QC 기준을 충족하는 최초 제출

2026년 9월 9일

처음 게시됨 (실제)

2026년 9월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 9일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PT-2026-35194
  • STUDY00029295 (기타 식별자: University Of Minnesota)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다