Status:
RECRUITING
Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
Lead Sponsor:
Brown University
Conditions:
Chronic Pain
Acute Pain
Eligibility:
All Genders
18+ years
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 ov...
Detailed Description
The investigators aim to study the temporal dynamics of pain and links between self-reported pain, mood/emotion, and activities using the daily tracking app SOMA. The experience of pain fluctuates ove...
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
Key Trial Info
Start Date :
June 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05754190
Start Date
June 20 2023
End Date
May 30 2026
Last Update
September 19 2025
Active Locations (1)
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1
Brown University
Providence, Rhode Island, United States, 02912