Treating Negative Affect in Low Back Pain Patients (NCT04747314) | Clinical Trial Compass
CompletedPhase 2/3
Treating Negative Affect in Low Back Pain Patients
United States308 participantsStarted 2021-03-31
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 stud…
What they're measuring
1
"Composite Responder", involving the domains of pain, function, and depression. See "Other Pre-Specified Outcomes" for description of these sub-components.