An observational study in Chronic Pain, Acute Pain and Post Operative Pain, sponsored by Brown University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Brown University · Observational
This study relies on the use of a smartphone application (SOMA) that the investigators developed for tracking daily mood, pain, and activity status in acute pain, chronic pain, and healthy controls over four months.The primary goal of the study is to use fluctuations in daily self-reported symptoms to identify computational predictors of acute-chronic pain transition, pain recovery, and/or chronic pain maintenance or flareups. The general study will include anyone with current acute or chronic pain, while a smaller sub-study will use a subset of patients from the chronic pain group who have been diagnosed with chronic low back pain, failed back surgery syndrome, or fibromyalgia. These sub-study participants will first take part in one in-person EEG testing session while completing simple interoception and reinforcement learning tasks and then begin daily use of the SOMA app. Electrophysiologic and behavioral data from the EEG testing session will be used to determine predictors of treatment response in the sub-study.
The investigators aim to study the temporal dynamics of pain and links between self-reported pain, mood/emotion, and activities using the daily tracking app SOMA. The experience of pain fluctuates over time, specifically in patients who suffer from chronic pain and those who are transitioning from an acute to a chronic state. Emotions and mood directly influence the experience of pain and may contribute to its chronification. The investigators will use statistical and computational approaches to better understand the dynamics of these reported daily symptoms to identify computational predictors of transition from acute to chronic pain. Specifically, the investigators hypothesize that certain symptom clusters will co-occur in time and be linked to external life events (e.g. emotional and physical stress) and emotional states (e.g. worry). Statistical/computational analysis of pain dynamics could therefore identify indicators for change points in the transition from acute to chronic pain.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 800 is above the median of 120 across 753 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
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Any person who fits the eligibility criteria for acute pain, chronic pain, or healthy control groups will be eligible to participate in the general parent study. Healthy controls or participants who have a diagnosis of chronic low back pain, failed back surgery syndrom or fibromyalgia are eligible to participate in the in-person EEG sub-study.
Participants will be recruited from around Rhode Island and surrounding regions via online ads, listserv announcements, local healthcare clinics, rehab and nursing facilities, word of mouth, social media, and targeted newspaper/magazine/public transportation advertisements. Chronic pain participants eligible for the in-person EEG testing will be recruited via these methods as well as targeted recruitment with physicians treating these patients.
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.
Chronic pain group:
Acute pain group:
Average pain intensity score of greater than 3 in the past week
○ or
Average pain interference score of greater than 3 in the past week
○ or
Healthy control group:
In person EEG testing [Sub-Study only]:
EXCLUSION CRITERIA [General study]
Chronic pain group:
Acute pain group:
History of Chronic Pain (Pain lasting for more than 6 months)
Not fluent in English (difficulty understanding questions)
-In person EEG testing [Sub-study only]: [will interfere with EEG data collection safety or quality]:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
\[general study + sub study\] No history of chronic pain
Device: SOMA pain manager smartphone application
\[general study\] Pain duration \< 3 months
Device: SOMA pain manager smartphone application
\[general study\] Pain duration \> 6 months \[sub-study\] diagnosis of chronic low back pain, failed back surgery syndrome, or fibromyalgia
Device: SOMA pain manager smartphone application
SOMA is a smartphone application developed for acute and chronic pain patients to track daily mood and pain symptoms and overall activity.
[General Study] Acute-Chronic Pain Transition Probability
Test whether daily affect (incl. mood), pain, activities, and other factors measured by the SOMA app can predict transition from acute to chronic pain, pain recovery, or pain maintenance using mixed effects linear regression model-based analyses to predict long- term pain scores such as pain intensity, unpleasantness, and/or interference
Time frame: T1 [4 months of daily app use]
[General Study] Feasibility of long-term app use
Percentage of Soma users in acute and chronic pain groups who engage with the app for 4 months
Time frame: T1 [4 months of daily app use]
[General Study] App Engagement
Evaluate user engagement based on number of completed daily ESM assessments per person in the acute and chronic pain groups over the 4 months of app use
Time frame: T1 [4 months of daily app use]
[General Study] Pain Dynamics
Test whether variability in daily pain location, intensity, unpleasantness, and interference, and daily pain expectations and prediction errors in the SOMA app can predict long-term pain scores in cross sectional between-group and longitudinal within-subject model-based analyses
Time frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
[General Study] Activity Dynamics
Test whether types or number of daily activities, the effect of activities on pain, and activity expectations for the next day can predict long-term pain scores in cross sectional and longitudinal model-based analyses.
Time frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
[General Study] Pain Beliefs
Test whether questionnaire scores related to pain beliefs and personal/health history at T0 can predict long-term pain scores in cross sectional between-group and longitudinal within-subject model-based analyses
Time frame: T0 [Baseline], T2 [4 months], T3 [8 months], T4 [12 months]
[General study] Mood Dynamics
Test whether variability in daily mood ratings and mood prediction errors can predict long-term pain scores in cross sectional between-group and longitudinal within-subject model-based analyses.
Time frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
[General Study] Association between mood, pain, and activity
Assess the effect of mood, pain, pain prediction errors and mood prediction errors on future activities in cross sectional between-group and longitudinal within-subject model based analyses.
Time frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
[General Study] Mood homeostasis as measured by SOMA app mood screens
Assess mood homeostasis using SOMA mood screens in cross sectional between-group and longitudinal within-subject model based analyses.
Time frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
[General Study] Effect of Treatments on pain and mood as measured by SOMA app screens
Assess the effect of pain treatments on mood, pain and activities using the dedicated SOMA screens for these measures in cross sectional between-group and longitudinal within-subject model based analyses.
Time frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
[General Study] Avoidance Learning task-computer game
Test harm avoidance learning and generalization differences between pain patients and healthy controls using a computerized reinforcement learning game.
Time frame: T0 [Baseline], T2 [4 months]
[Sub-Study] Avoidance Learning Task-EEG
Test whether EEG frontal theta band power is increased during prediction error processing and harm avoidance contexts in a reinforcement learning task in cross-sectional between-group analyses.
Time frame: T0 [Baseline]
[Sub-Study] Cardiac Interoceptive Attention Task-EEG
Test whether cross-sectional differences in EEG-measured Heartbeat-evoked potential (HEP) amplitude when attending to interoceptive vs exteroceptive stimuli differ between pain patients and healthy controls and test relationship to questionnaire measures at baseline and follow-up.
Time frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
[Sub-study] Resting state- EEG
Test cross-sectional differences in EEG-measured Resting State Activity between pain groups and healthy controls and test relationships between resting EEG measures and questionnaire results at baseline and follow-up
Time frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
[Sub-study] Treatment outcome prediction in chronic low back pain and failed back surgery syndrome patients
Test whether baseline EEG HEP and questionnaire measures predict pain scores at T3 following invasive back treatments (eg back surgery, spinal cord stimulation, radio-frequency ablation) that occur during T1.
Time frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
Plan to share: No — Anyone interested in IPD should reach out to the Principal Investigator
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