Chronic Low Back PainSERENITYNCT07820475
SERENITY Study of Chronic Pain Interference in Adults
An observational study of Chronic Low Back Pain and Spinal Cord Injury, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain, Spinal Cord Injury, Neuropathic Pain
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
Ann Van de Winckel, PhD, MSPT, avandewi@umn.edu
Ann Van de Winckel, PhD, MSPT
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Low Back Pain, Spinal Cord Injury, Neuropathic Pain, Chronic Pain, Pain Interference
- Keywords
- EMA, SERENITY, Chronic pain, Chronic low back pain, Fitbit
- Medical subject headings
- Spinal Cord Injuries, Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Four times daily for at least 3 weeks
Secondary outcomes (26)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Throughout the study assessment period, at least 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Sep 2031 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Ann Van de Winckel, PhD, MSPT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820475
- Sponsor's protocol ID
- PT-2026-35194
- Other IDs
- STUDY00029295
- Acronym
- SERENITY
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling of Inter-Individual Differences in Chronic Pain Using Holistic Measures of Pain Severity, Stress, Cognition, Body and Mind Awareness
- ClinicalTrials.gov ID
- NCT07820475
- Acronym / sponsor ID
- SERENITY / PT-2026-35194
- Conditions
- Chronic Low Back Pain, Spinal Cord Injury, Neuropathic Pain, Chronic Pain, Pain Interference
- Keywords
- EMA, SERENITY, Chronic pain, Chronic low back pain, Fitbit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Interference With Function
Time frame: Four times daily for at least 3 weeks
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
26 secondary outcomes
Pain, Enjoyment of Life and General Activity Scale Score
Time frame: Baseline
Brief Pain Inventory Short Form Pain Severity Composite Score
Time frame: Baseline
Brief Pain Inventory Short Form Pain Interference Composite Score
Time frame: Baseline
Spinal Cord Injury Functional Index/Assistive Technology Score
Time frame: Baseline
Roland-Morris Low Back Pain and Disability Questionnaire Score
Time frame: Baseline
Patient Health Questionnaire-4 Score
Time frame: Baseline
World Health Organization Quality of Life 2-Item Score
Time frame: Baseline
Cognitive and Affective Mindfulness Scale-Revised Score
Time frame: Baseline
Pain Resilience Scale Score
Time frame: Baseline
Positive and Negative Affect Schedule Short Form - Positive Affectivity Score
Time frame: Four times daily for at least 3 weeks
Positive and Negative Affect Schedule Short Form - Negative Affectivity Score
Time frame: Four times daily for at least 3 weeks
EMA Relaxation Score
Time frame: Four times daily for at least 3 weeks
EMA Energy Score
Time frame: Four times daily for at least 3 weeks
EMA Control Score
Time frame: Four times daily for at least 3 weeks
EMA Sleep Difficulty Score
Time frame: Four times daily for at least 3 weeks
EMA Fear of Movement Score
Time frame: Four times daily for at least 3 weeks
EMA Pain Intensity Score
Time frame: Four times daily for at least 3 weeks
Time to Completion for EMA Number Sequencing Task
Time frame: Four times daily for at least 3 weeks
Time to Completion for EMA Number-Letter Sequencing Task
Time frame: Four times daily for at least 3 weeks
Percent Correct for EMA Spatial Working Memory Task
Time frame: Four times daily for at least 3 weeks
Fitbit-Derived Sleep Duration
Time frame: Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Physical Activity
Time frame: Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Heart Rate
Time frame: Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Heart Rate Variability
Time frame: Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Daily Readiness Score
Time frame: Throughout the study assessment period, at least 3 weeks
Fitbit-Derived Stress Management Score
Time frame: Throughout the study assessment period, at least 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Van de Winckel, PhD, MSPT principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain and Spinal Cord Injury, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Van de Winckel, PhD, MSPT (6124062500, avandewi@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Interference With Function (time frame: Four times daily for at least 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.