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Treating Negative Affect in Low Back Pain Patients

CompletedPhase 2NCT04747314
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain
Conditions
Interventions
  • Drug: Antidepressant
  • Other: Enhanced Fear Avoidance Rehabilitation
Sponsor
Ajay Wasan, MD, Msc
Collaborators
National Institutes of Health (NIH); National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Mayo Clinic; Massachusetts General Hospital
Organization
University of Pittsburgh
Start date
2021-03-31
Primary completion
2024-11-04
Sex
All
Age range
from 18 Years to 75 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
3

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 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 …

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04747314