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Not Yet Recruiting NCT05754190

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

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

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 800
Sponsor: Brown University

Location: United States

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 Criteria

INCLUSION CRITERIA [General study]Chronic pain group:Age above 18Access to a personal smartphone and a stable internet connectionAverage pain intensity score of greater than 3 in the past week orAverage pain interference score of greater than 3 in the past week orAverage pain distress score of greater than 3 in the past weekPain duration: greater than 6 monthsAcute pain group:Age above 18Access to a personal smartphone and a stable internet connectionAverage pain intensity score of greater than 3 in the past week○ orAverage pain interference score of greater than 3 in the past week○ orAverage pain distress score of greater than 3 in the past weekPain duration: less than 3 monthsPain cause: Due to recent surgery, injury, acute illness, or childbirth (within the past 3 months)Healthy control group:Age above 18Access to a personal smartphone and a stable internet connectionAverage pain intensity score of less than 3 in the past weekAverage pain interference score of less than 3 in the past weekAverage pain distress score of less than 3 in the past weekNo 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 ORNo current or prior history of chronic painIf 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 monthsIf participant has chronic low back pain or failed back surgery syndrome: have they received insurance approval for the procedure?Ok with EEC/ECG measuresEXCLUSION CRITERIA [General study]Chronic pain group:recent injury or surgery unrelated to the pain in the past 3 monthsdifficulty 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:BaldnessPregnancyDreadlocksLeft-handednessUse of a wheelchairHeart failure diagnosisCurrent or prior experience with acute psychosis or maniaimplanted pacemaker, neurostimulator or any other head or heart implantsrequire a hearing aid to hear properlyclaustrophobiametal fragments in the body

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05754190). StuddyBuddy aggregates publicly available trial information.