SERENITY Study of Chronic Pain Interference in Adults (SERENITY)
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.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Ann Van de Winckel, PhD, MSPT
- Telefonnummer: 612-406-2500
- E-Mail: avandewi@umn.edu
Studienorte
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55455
- University of Minnesota
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Kontakt:
- Ann Van de Winckel, PhD, MSPT
- Telefonnummer: 612-406-2500
- E-Mail: avandewi@umn.edu
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Hauptermittler:
- Ann Van de Winckel, PhD, MSPT
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Anzahl der Gruppen / Kohorten
Kohorten und Interventionen
Gruppe / KohorteGruppe / Kohorte |
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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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Pain Interference With Function
Zeitfenster: Four times daily for at least 3 weeks
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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
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pain, Enjoyment of Life and General Activity Scale Score
Zeitfenster: Baseline
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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
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Brief Pain Inventory Short Form Pain Severity Composite Score
Zeitfenster: Baseline
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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
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Brief Pain Inventory Short Form Pain Interference Composite Score
Zeitfenster: Baseline
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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
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Spinal Cord Injury Functional Index/Assistive Technology Score
Zeitfenster: Baseline
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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
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Roland-Morris Low Back Pain and Disability Questionnaire Score
Zeitfenster: Baseline
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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
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Patient Health Questionnaire-4 Score
Zeitfenster: Baseline
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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
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World Health Organization Quality of Life 2-Item Score
Zeitfenster: Baseline
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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
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Cognitive and Affective Mindfulness Scale-Revised Score
Zeitfenster: Baseline
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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
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Pain Resilience Scale Score
Zeitfenster: Baseline
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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
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Positive and Negative Affect Schedule Short Form - Positive Affectivity Score
Zeitfenster: Four times daily for at least 3 weeks
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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
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Positive and Negative Affect Schedule Short Form - Negative Affectivity Score
Zeitfenster: Four times daily for at least 3 weeks
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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
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EMA Relaxation Score
Zeitfenster: Four times daily for at least 3 weeks
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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
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EMA Energy Score
Zeitfenster: Four times daily for at least 3 weeks
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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
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EMA Control Score
Zeitfenster: Four times daily for at least 3 weeks
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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
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EMA Sleep Difficulty Score
Zeitfenster: Four times daily for at least 3 weeks
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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
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EMA Fear of Movement Score
Zeitfenster: Four times daily for at least 3 weeks
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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
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EMA Pain Intensity Score
Zeitfenster: Four times daily for at least 3 weeks
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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
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Time to Completion for EMA Number Sequencing Task
Zeitfenster: Four times daily for at least 3 weeks
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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
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Time to Completion for EMA Number-Letter Sequencing Task
Zeitfenster: Four times daily for at least 3 weeks
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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
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Percent Correct for EMA Spatial Working Memory Task
Zeitfenster: Four times daily for at least 3 weeks
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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
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Fitbit-Derived Sleep Duration
Zeitfenster: Throughout the study assessment period, at least 3 weeks
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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
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Fitbit-Derived Physical Activity
Zeitfenster: Throughout the study assessment period, at least 3 weeks
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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
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Fitbit-Derived Heart Rate
Zeitfenster: Throughout the study assessment period, at least 3 weeks
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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
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Fitbit-Derived Heart Rate Variability
Zeitfenster: Throughout the study assessment period, at least 3 weeks
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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
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Fitbit-Derived Daily Readiness Score
Zeitfenster: Throughout the study assessment period, at least 3 weeks
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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
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Fitbit-Derived Stress Management Score
Zeitfenster: Throughout the study assessment period, at least 3 weeks
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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
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Ermittler
Ermittler
- Hauptermittler: Ann Van de Winckel, PhD, MSPT, University of Minnesota
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schmerzen
- Neurologische Manifestationen
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Wunden und Verletzungen
- Neuromuskuläre Erkrankungen
- Erkrankungen des peripheren Nervensystems
- Trauma, Nervensystem
- Erkrankungen des Rückenmarks
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Chronischer Schmerz
- Neuralgie
- Verletzungen des Rückenmarks
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- PT-2026-35194
- STUDY00029295 (Andere Kennung: University Of Minnesota)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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