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

NCT05754190 | Recruiting

• 1 other identifier: 2022003301
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Acute Pain; Post Operative Pain; Fibromyalgia, Primary; Fibromyalgia, Secondary; Fibromyalgia; Irritable Bowel Syndrome; Chronic Headache Disorder; Chronic Migraine; Chronic Pelvic Pain Syndrome; Temporomandibular Joint Disorders; Endometriosis-related Pain; Arthritis; Chronic Low-back Pain; Failed Back Surgery Syndrome; Post Herpetic Neuralgia; Neuropathic Pain; Painful Diabetic Neuropathy; Painful Bladder Syndrome; Trauma-related Wound; Trauma, Multiple; Chronic Pain Syndrome; Chronic Shoulder Pain

Keywords

digital health; e-health; smartphone application; chronic pain; acute pain; symptom tracking; experience sampling methodology; ecological momentary assessment; pain self-management

Outcome Measures

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

  T1 [4 months of daily app use]

Secondary Outcomes (14)

• [General Study] Feasibility of long-term app use

  T1 [4 months of daily app use]

• [General Study] App Engagement

  T1 [4 months of daily app use]

• [General Study] Pain Dynamics

  T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]

• [General Study] Activity Dynamics

  T0 [Baseline], T1 [4 months of daily app use], T2 [4 months], T3 [8 months], T4 [12 months]

• [General Study] Pain Beliefs

  T0 [Baseline], T2 [4 months], T3 [8 months], T4 [12 months]

Study Arms (3)

Healthy Controls

\[general study + sub study\] No history of chronic pain

Device: SOMA pain manager smartphone application

Acute pain

\[general study\] Pain duration \< 3 months

Device: SOMA pain manager smartphone application

Chronic pain

\[general study\] Pain duration \> 6 months \[sub-study\] diagnosis of chronic low back pain, failed back surgery syndrome, or fibromyalgia

Device: SOMA pain manager smartphone application

Interventions

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.

Acute pain; Chronic pain; Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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 \[Sub-study only\]: \[will interfere with EEG data collection safety or quality\]:

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 21148657 BACKGROUND

• 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.

  PMID: 23823463 BACKGROUND

• 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.

  PMID: 22751038 BACKGROUND

• 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.

  PMID: 23983029 BACKGROUND

• 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.

  PMID: 11880847 BACKGROUND

Related Links

• To find out more information about Petzschner lab research
• To find out more about how to download and use the SOMA Pain Manager app

MeSH Terms

Conditions

Chronic Pain; Acute Pain; Pain, Postoperative; Fibromyalgia; Irritable Bowel Syndrome; Temporomandibular Joint Disorders; Arthritis; Failed Back Surgery Syndrome; Neuralgia, Postherpetic; Neuralgia; Diabetic Neuropathies; Cystitis, Interstitial; Multiple Trauma

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Joint Diseases; Stomatognathic Diseases; Back Pain; Peripheral Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries

Study Officials

• Frederike H Petzschner, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederike H Petzschner, PhD

CONTACT

401-863-6272; frederike_petzschner@brown.edu

Chloe S Zimmerman, MD/PhD student

CONTACT

401-863-6272; chloe_zimmerman@brown.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Psychiatry and Human Behavior; Carney Institute for Brain Science

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 3, 2023
• Study Start: June 20, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)