Health TrialsbyHealthPanel

SERENITY Study of Chronic Pain Interference in Adults

ConditionsChronic Low Back PainSpinal Cord InjuryNeuropathic PainChronic PainPain Interference
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: Adults With Chronic Low Back Pain
Group B: Adults With SCI-Related Neuropathic Pain

Trial outcomes

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

Time frame
Four times daily for at least 3 weeks

Secondary outcomes

1

Pain, Enjoyment of Life and General Activity Scale Score

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

Time frame
Baseline
2

Brief Pain Inventory Short Form Pain Severity Composite Score

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

Time frame
Baseline
3

Brief Pain Inventory Short Form Pain Interference Composite Score

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

Time frame
Baseline
4

Spinal Cord Injury Functional Index/Assistive Technology Score

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: