An observational study in Chronic Low Back Pain, Spinal Cord Injury and Neuropathic Pain, sponsored by University of Minnesota. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Minnesota · Observational
Among 15 studies in Spinal Cord Injuries by University of Minnesota — 7 open to participants now, 7 under way, none of them phase 3. Spinal Cord Injuries · University of Minnesota.
Among the 15 studies in Spinal Cord Injuries by University of Minnesota, this one is one of 2 that started in 2026, is one of 3 observational ones, and was the 15th registered.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 332 observational studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →7 of the 15 studies in Spinal Cord Injuries by University of Minnesota are open now, in 1 country. Each count lists the studies.
Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 2 started in 2026.
Median enrollment 38 across the 12 interventional studies, 113 across the 3 observational. Of the 8 that completed or were terminated, 2 (25%) have results posted.
University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
4 of the studies in Spinal Cord Injuries by University of Minnesota that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03026816University of MinnesotaEpidural Stimulation After Neurologic Damage | 2027-01 |
| NCT06140355University of MinnesotacHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury | 2027-01-31 |
| NCT07029802University of MinnesotaDevelopment of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury | 2027-06-15 |
| NCT05741788University of MinnesotaThe Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain | 2027-10-01 |
Among the 15 studies in Spinal Cord Injuries by University of Minnesota, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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.
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
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
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
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
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
Roland-Morris Low Back Pain and Disability Questionnaire Score
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
Time frame: Baseline
Patient Health Questionnaire-4 Score
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
Time frame: Baseline
World Health Organization Quality of Life 2-Item Score
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
Time frame: Baseline
Cognitive and Affective Mindfulness Scale-Revised Score
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
Time frame: Baseline
Pain Resilience Scale Score
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
Time frame: Baseline
Positive and Negative Affect Schedule Short Form - Positive Affectivity Score
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
Time frame: Four times daily for at least 3 weeks
Positive and Negative Affect Schedule Short Form - Negative Affectivity Score
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
Time frame: Four times daily for at least 3 weeks
EMA Relaxation Score
Relaxation will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating better relaxation. Unit: points
Time frame: Four times daily for at least 3 weeks
EMA Energy Score
Energy will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating better energy. Unit: points
Time frame: Four times daily for at least 3 weeks
EMA Control Score
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
Time frame: Four times daily for at least 3 weeks
EMA Sleep Difficulty Score
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
Time frame: Four times daily for at least 3 weeks
EMA Fear of Movement Score
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
Time frame: Four times daily for at least 3 weeks
EMA Pain Intensity Score
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
Time frame: Four times daily for at least 3 weeks
Time to Completion for EMA Number Sequencing Task
Attention will be assessed using a smartphone-based number sequencing task. Performance will be reported as time to completion. Unit: Seconds
Time frame: Four times daily for at least 3 weeks
Time to Completion for EMA Number-Letter Sequencing Task
Set-shifting will be assessed using a smartphone-based number-letter sequencing task. Performance will be reported as time to completion. Unit: Seconds
Time frame: Four times daily for at least 3 weeks
Percent Correct for EMA Spatial Working Memory Task
Spatial working memory will be assessed using a smartphone-based spatial working memory task. Performance will be reported as percent correct. Unit: percent correct
Time frame: Four times daily for at least 3 weeks
Fitbit-Derived Sleep Duration
Sleep duration will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: hours
Time frame: Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Physical Activity
Physical activity will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: Steps
Time frame: Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Heart Rate
Heart rate will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: beats per minute
Time frame: Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Heart Rate Variability
Heart rate variability will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: milliseconds
Time frame: Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Daily Readiness Score
Daily readiness will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: points
Time frame: Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Stress Management Score
Stress management will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: points
Time frame: Throughout the study assessment period, at least 3 weeks
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.