SERENITY Study of Chronic Pain Interference in Adults

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07820475
Status
Not Yet Recruiting

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Conditions

  • Chronic Low Back Pain
  • Chronic Pain
  • Neuropathic Pain
  • Pain Interference
  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Sep 15, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2031
Completion
Sep 30, 2031

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Pain Interference With Function [ Time Frame: Four times daily for at least 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Ann Van de Winckel, PhD, MSPT
[email protected]
612-406-2500
Ann Van de Winckel, PhD, MSPT (PRINCIPAL_INVESTIGATOR)

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