SERENITY Study of Chronic Pain Interference in Adults

NCT07820475 | Not Yet Recruiting

• 2 other identifiers: PT-2026-35194STUDY00029295
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

EMA; SERENITY; Chronic pain; Chronic low back pain; Fitbit

Outcome Measures

Primary Outcomes (1)

• Pain Interference With Function

  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

Secondary Outcomes (26)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia; Chronic Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann Van de Winckel, PhD, MSPT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Van de Winckel, PhD, MSPT

CONTACT

612-406-2500; avandewi@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

US (1)