Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain

PRO19100026

This study will examine how the use of antidepressant, physical therapy, and combination of both affects pain, function, and depression outcomes in chronic low back pain patients.

2021-03-31

2025-12-31

2026-04-30

Recruiting

Early phase I

330

Inclusion Criteria: * Ages 18-75 * Pain duration \> 6 months * Must meet the minimum criteria for cognitive function using the PROMIS 2-item cognitive screener (\>3) * Average pain score of \> 3/10, with low back pain being the primary pain site * CLBP meeting Quebec Task Force Classification System categories I-III (from axial pain only to pain radiating beyond the knee without neurological signs). Constant radicular pain associated with sensory loss is highly treatment resistant without surgery * In the investigator's judgment, evidence of healthcare seeking for low back pain. * Must meet criteria for high negative affect at 1st study visit: at least 5 on the PHQ-4 (also called the PHQ-2 + GAD-2). Scores above this level are highly associated with having a co-morbid major depression or generalized anxiety disorder diagnosis * Having accessible electronic medical records from UPMC, Brigham and Women's Hospital, or Mayo Clinic, Rochester. * For those taking opioids (the opioid subgroup), participants must be prescribed opioids currently for at least 3 consecutive months prior to enrollment. Patients must be on opioids for a minimum of three months, taking them on a daily basis or intermittently during the week. The investigators will include those on strong opioids, such as oxycodone and weak opioids, such as tramadol. * Subject must agree that opioids cannot be increased during the study * For those taking opioids, no active substance use disorder in the past year as determined by the PI with the use of the Tobacco, Alcohol, Prescription Medications, and Other Substance Tool (TAPS) and a urine toxicology screen. The exceptions are tobacco, medical marijuana use in Pennsylvania or Minnesota, recreational or medical marijuana in the Boston site, or mild prescription opioid use disorder such as opioid misuse * No acute suicidality or history of major thought disorder (such as mania or psychosis). This will be assessed at study entry which will also include a review of history in EPIC/EMR * Must possess a mobile device or tablet that can send and receive text messages and access the internet Exclusion Criteria: * Back surgery within the past six months * Active worker's compensation or litigation claims * New pain and/or psychiatric treatments within 2 weeks of enrollment * Intent to add new or increase pain treatments during the study period, such as back surgery, nerve block procedures, or medications * Intent to add new psychiatric treatments during the first 4 months of the study * Any clinically unstable systemic illness that is judged to interfere with the trial * History of cardiac, nervous system, or respiratory disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for respiratory depression * Non-ambulatory status * Pregnancy or the intent to become pregnant during the study. Women of childbearing potential will all submit a urine sample pregnancy testing at enrollment. * Not fluent in English and/or not able to complete the questionnaires

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2024-02-20