- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05754190
Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
Study Overview
Status
Conditions
- Arthritis
- Chronic Pain
- Chronic Low-back Pain
- Irritable Bowel Syndrome
- Fibromyalgia
- Acute Pain
- Trauma, Multiple
- Neuropathic Pain
- Temporomandibular Joint Disorders
- Post Operative Pain
- Chronic Pain Syndrome
- Chronic Shoulder Pain
- Painful Diabetic Neuropathy
- Chronic Migraine
- Painful Bladder Syndrome
- Failed Back Surgery Syndrome
- Fibromyalgia, Primary
- Fibromyalgia, Secondary
- Endometriosis-related Pain
- Chronic Pelvic Pain Syndrome
- Post Herpetic Neuralgia
- Trauma-related Wound
- Chronic Headache Disorder
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Frederike H Petzschner, PhD
- Phone Number: 401-863-6272
- Email: frederike_petzschner@brown.edu
Study Contact Backup
- Name: Chloe S Zimmerman, MD/PhD Student
- Phone Number: 401-863-6272
- Email: chloe_zimmerman@brown.edu
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Recruiting
- Brown University
-
Contact:
- Frederike H Petzschner, PhD
- Phone Number: 401-863-6272
- Email: frederike_petzschner@brown.edu
-
Contact:
- Chloe S Zimmerman, MD/PhD Student
- Phone Number: 401-863-6272
- Email: chloe_zimmerman@brown.edu
-
Principal Investigator:
- Frederike H Petzschner, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Description
INCLUSION CRITERIA [General study]
Chronic pain group:
- Age above 18
- Access to a personal smartphone and a stable internet connection
- 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
- Average pain distress score of greater than 3 in the past week
- Pain duration: greater than 6 months
Acute pain group:
- Age above 18
- Access to a personal smartphone and a stable internet connection
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
- Average pain distress score of greater than 3 in the past week
- Pain duration: less than 3 months
- Pain cause: Due to recent surgery, injury, acute illness, or childbirth (within the past 3 months)
Healthy control group:
- Age above 18
- Access to a personal smartphone and a stable internet connection
- Average pain intensity score of less than 3 in the past week
- Average pain interference score of less than 3 in the past week
- Average pain distress score of less than 3 in the past week
- No surgery, injury, acute illness, or childbirth (within the past 3 months)
In person EEG testing [Sub-Study only]:
- Same as in General App Study Above and additionally:
- Current diagnosis of Fibromyalgia, Chronic Low Back Pain or Failed Back Surgery Syndrome OR
- No current or prior history of chronic pain
- If participant has chronic low back pain or failed back surgery syndrome: are they planning to have either a radio-frequency ablation, back surgery, or spinal cord stimulation implant in the next few months
- If participant has chronic low back pain or failed back surgery syndrome: have they received insurance approval for the procedure?
- Ok with EEC/ECG measures
EXCLUSION CRITERIA [General study]
Chronic pain group:
- recent injury or surgery unrelated to the pain in the past 3 months
- difficulty participating for technical/logistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation);
- Not fluent in English (difficulty understanding questions)
- Current primary or metastatic cancer (organic cause of pain)
Acute pain group:
- History of Chronic Pain (Pain lasting for more than 6 months)
- difficulty participating for technical/logistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation);
- Not fluent in English (difficulty understanding questions)
- Current primary or metastatic cancer (organic cause of pain)
- Healthy control group:
History of Chronic Pain (Pain lasting for more than 6 months)
- difficulty participating for technical/logistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation);
Not fluent in English (difficulty understanding questions)
-In person EEG testing [Sub-study only]: [will interfere with EEG data collection safety or quality]:
- Same as in General App Study Above and additionally:
- Baldness
- Pregnancy
- Dreadlocks
- Left-handedness
- Use of a wheelchair
- Heart failure diagnosis
- Current or prior experience with acute psychosis or mania
- implanted pacemaker, neurostimulator or any other head or heart implants
- require a hearing aid to hear properly
- claustrophobia
- metal fragments in the body
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Controls
[general study + sub study] No history of chronic pain
|
SOMA is a smartphone application developed for acute and chronic pain patients to track daily mood and pain symptoms and overall activity.
|
Acute pain
[general study] Pain duration < 3 months
|
SOMA is a smartphone application developed for acute and chronic pain patients to track daily mood and pain symptoms and overall activity.
|
Chronic pain
[general study] Pain duration > 6 months [sub-study] diagnosis of chronic low back pain, failed back surgery syndrome, or fibromyalgia |
SOMA is a smartphone application developed for acute and chronic pain patients to track daily mood and pain symptoms and overall activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[General Study] Acute-Chronic Pain Transition Probability
Time Frame: T1 [4 months of daily app use]
|
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
|
T1 [4 months of daily app use]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[General Study] App Engagement
Time Frame: T1 [4 months of daily app use]
|
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
|
T1 [4 months of daily app use]
|
[General Study] Pain Dynamics
Time Frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
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
|
T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
[General Study] Activity Dynamics
Time Frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
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.
|
T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
[General Study] Pain Beliefs
Time Frame: T0 [Baseline], T2 [4 months], T3 [8 months], T4 [12 months]
|
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
|
T0 [Baseline], T2 [4 months], T3 [8 months], T4 [12 months]
|
[General study] Mood Dynamics
Time Frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
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.
|
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
Time Frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
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.
|
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
Time Frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
Assess mood homeostasis using SOMA mood screens in cross sectional between-group and longitudinal within-subject model based analyses.
|
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
Time Frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
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.
|
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
Time Frame: T0 [Baseline], T2 [4 months]
|
Test harm avoidance learning and generalization differences between pain patients and healthy controls using a computerized reinforcement learning game.
|
T0 [Baseline], T2 [4 months]
|
[Sub-Study] Avoidance Learning Task-EEG
Time Frame: T0 [Baseline]
|
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.
|
T0 [Baseline]
|
[Sub-Study] Cardiac Interoceptive Attention Task-EEG
Time Frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
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.
|
T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
[Sub-study] Resting state- EEG
Time Frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
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
|
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
Time Frame: T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
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.
|
T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]
|
[General Study] Feasibility of long-term app use
Time Frame: T1 [4 months of daily app use]
|
Percentage of Soma users in acute and chronic pain groups who engage with the app for 4 months
|
T1 [4 months of daily app use]
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frederike H Petzschner, PhD, Brown University
Publications and helpful links
General Publications
- Voscopoulos C, Lema M. When does acute pain become chronic? Br J Anaesth. 2010 Dec;105 Suppl 1:i69-85. doi: 10.1093/bja/aeq323.
- Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain. Spine (Phila Pa 1976). 2002 Mar 1;27(5):E109-20. doi: 10.1097/00007632-200203010-00017.
- Apkarian AV, Baliki MN, Farmer MA. Predicting transition to chronic pain. Curr Opin Neurol. 2013 Aug;26(4):360-7. doi: 10.1097/WCO.0b013e32836336ad.
- Baliki MN, Petre B, Torbey S, Herrmann KM, Huang L, Schnitzer TJ, Fields HL, Apkarian AV. Corticostriatal functional connectivity predicts transition to chronic back pain. Nat Neurosci. 2012 Jul 1;15(8):1117-9. doi: 10.1038/nn.3153.
- Hashmi JA, Baliki MN, Huang L, Baria AT, Torbey S, Hermann KM, Schnitzer TJ, Apkarian AV. Shape shifting pain: chronification of back pain shifts brain representation from nociceptive to emotional circuits. Brain. 2013 Sep;136(Pt 9):2751-68. doi: 10.1093/brain/awt211.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Digestive System Diseases
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Urologic Diseases
- Urinary Bladder Diseases
- Postoperative Complications
- Neurologic Manifestations
- Endocrine System Diseases
- Disease
- Gastrointestinal Diseases
- Diabetes Complications
- Diabetes Mellitus
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Stomatognathic Diseases
- Peripheral Nervous System Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Arthralgia
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Back Pain
- Cystitis
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Pain, Postoperative
- Syndrome
- Low Back Pain
- Irritable Bowel Syndrome
- Chronic Pain
- Neuralgia
- Wounds and Injuries
- Endometriosis
- Fibromyalgia
- Shoulder Pain
- Somatoform Disorders
- Myofascial Pain Syndromes
- Headache
- Pain
- Acute Pain
- Multiple Trauma
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Diabetic Neuropathies
- Cystitis, Interstitial
- Headache Disorders
- Pelvic Pain
- Neuralgia, Postherpetic
- Failed Back Surgery Syndrome
Other Study ID Numbers
- 2022003301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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