Chronic Low Back Pain, Chronic Pain, Neuropathic Pain, Pain Interference, Spinal Cord Injury
Conditions
Keywords
EMA, SERENITY, Chronic pain, Chronic low back pain, Fitbit
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.
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.
Interventions
None listed
Sponsors
University of Minnesota
National Center for Complementary and Integrative Health (NCCIH)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference With Function | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain, Enjoyment of Life and General Activity Scale Score | Baseline | 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 |
| Brief Pain Inventory Short Form Pain Severity Composite Score | Baseline | 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 |
| Brief Pain Inventory Short Form Pain Interference Composite Score | Baseline | 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 |
| Spinal Cord Injury Functional Index/Assistive Technology Score | Baseline | 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 |
| Roland-Morris Low Back Pain and Disability Questionnaire Score | Baseline | 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 |
| Patient Health Questionnaire-4 Score | Baseline | 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 |
| World Health Organization Quality of Life 2-Item Score | Baseline | 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 |
| Cognitive and Affective Mindfulness Scale-Revised Score | Baseline | 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 |
| Pain Resilience Scale Score | Baseline | 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 |
| Positive and Negative Affect Schedule Short Form - Positive Affectivity Score | Four times daily for at least 3 weeks | 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 |
| Positive and Negative Affect Schedule Short Form - Negative Affectivity Score | Four times daily for at least 3 weeks | 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 |
| EMA Relaxation Score | Four times daily for at least 3 weeks | Relaxation will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating better relaxation. Unit: points |
| EMA Energy Score | Four times daily for at least 3 weeks | Energy will be assessed using a single ecological momentary assessment item scored from 0 to 4, with higher scores indicating better energy. Unit: points |
| EMA Control Score | Four times daily for at least 3 weeks | 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 |
| EMA Sleep Difficulty Score | Four times daily for at least 3 weeks | 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 |
| EMA Fear of Movement Score | Four times daily for at least 3 weeks | 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 |
| EMA Pain Intensity Score | Four times daily for at least 3 weeks | 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 to Completion for EMA Number Sequencing Task | Four times daily for at least 3 weeks | Attention will be assessed using a smartphone-based number sequencing task. Performance will be reported as time to completion. Unit: Seconds |
| Time to Completion for EMA Number-Letter Sequencing Task | Four times daily for at least 3 weeks | Set-shifting will be assessed using a smartphone-based number-letter sequencing task. Performance will be reported as time to completion. Unit: Seconds |
| Percent Correct for EMA Spatial Working Memory Task | Four times daily for at least 3 weeks | Spatial working memory will be assessed using a smartphone-based spatial working memory task. Performance will be reported as percent correct. Unit: percent correct |
| Fitbit-Derived Sleep Duration | Throughout the study assessment period, at least 3 weeks | Sleep duration will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: hours |
| Fitbit-Derived Physical Activity | Throughout the study assessment period, at least 3 weeks | Physical activity will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: Steps |
| Fitbit-Derived Heart Rate | Throughout the study assessment period, at least 3 weeks | Heart rate will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: beats per minute |
| Fitbit-Derived Heart Rate Variability | Throughout the study assessment period, at least 3 weeks | Heart rate variability will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: milliseconds |
| Fitbit-Derived Daily Readiness Score | Throughout the study assessment period, at least 3 weeks | Daily readiness will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: points |
| Fitbit-Derived Stress Management Score | Throughout the study assessment period, at least 3 weeks | Stress management will be measured passively using Fitbit Charge 6 during the study assessment period. Unit: points |
Countries
United States
Contacts
CONTACTAnn Van de Winckel, PhD, MSPT
PRINCIPAL_INVESTIGATORAnn Van de Winckel, PhD, MSPT
University of Minnesota
Outcome results
None listed