Health TrialsbyHealthPanel

Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA

ConditionsChronic PainAcute PainPost Operative PainFibromyalgia, PrimaryFibromyalgia, SecondaryFibromyalgiaIrritable Bowel SyndromeChronic Headache DisorderChronic MigraineChronic Pelvic Pain SyndromeTemporomandibular Joint DisordersEndometriosis-related PainArthritisChronic Low-back PainFailed Back Surgery SyndromePost Herpetic NeuralgiaNeuropathic PainPainful Diabetic NeuropathyPainful Bladder SyndromeTrauma-related WoundTrauma, MultipleChronic Pain SyndromeChronic Shoulder Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBrown University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SOMA pain manager smartphone application

    Device

    SOMA is a smartphone application developed for acute and chronic pain patients to track daily mood and pain symptoms and overall activity.

Treatment groups

800 Participants
are divided into 3 treatment groups
Group A: Healthy Controls1 intervention
Group B: Acute pain1 intervention
Group C: Chronic pain1 intervention

Trial outcomes

Primary outcomes

1

[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]

Secondary outcomes

1

[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]
2

[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]
3

[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]
4

[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]

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brown University

Lead sponsor

Source ClinicalTrials.gov
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