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

Launched by BROWN UNIVERSITY · Feb 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how daily mood, pain levels, and activity can change over time for people experiencing both acute and chronic pain. Researchers have developed a smartphone application called SOMA to help track these changes. The main goal is to understand how fluctuations in symptoms can predict whether someone’s pain might turn into a long-term issue or improve over time. The study is open to adults over 18 with ongoing pain or those who have been pain-free, and there is a special focus on participants with conditions like chronic low back pain or fibromyalgia.

Participants in the study will use the SOMA app daily for four months and may also take part in a one-time EEG testing session, which is a way to measure brain activity. To be eligible, participants need to have a certain level of pain or no pain at all, and they must have access to a smartphone and the internet. Throughout the trial, participants can expect to share their daily experiences and help researchers learn more about pain management. It's important to note that those with certain medical conditions or recent surgeries may not qualify for the study.

Gender

ALL

Eligibility criteria

• • 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