Treating Negative Affect in Low Back Pain Patients

Completed · Phase 2/Phase 3

Conditions studied: Chronic Low Back Pain, Negative Affectivity

In brief

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.

Key facts

Study ID: NCT04747314
Run by: Ajay Wasan, MD, Msc
People needed: 308
Starts: 2021-03-31
Expected to finish: 2024-12-20
Last updated by the study team: 2026-01-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 PHQ-4 scores are used as a proxy for high scores on PROMIS depression and anxiety scales
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

You may not qualify if…

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

Where it is running

BWH Pain Management Center — Chestnut Hill, Massachusetts, United States
Mayo Clinic — Rochester, Minnesota, United States
UPMC Pain Medicine At Centre Commons — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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