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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Rhode Island
Brown University
RECRUITING
Providence
Contact Information
Primary
Frederike H Petzschner, PhD
frederike_petzschner@brown.edu
401-863-6272
Backup
Chloe S Zimmerman, MD/PhD student
chloe_zimmerman@brown.edu
401-863-6272
Time Frame
Start Date: 2023-06-20
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 800
Treatments
Healthy Controls
\[general study + sub study\] No history of chronic pain
Acute pain
\[general study\] Pain duration \< 3 months
Chronic pain
\[general study\] Pain duration \> 6 months~\[sub-study\] diagnosis of chronic low back pain, failed back surgery syndrome, or fibromyalgia
Sponsors
Leads: Brown University

This content was sourced from clinicaltrials.gov