Treating Negative Affect in Low Back Pain Patients

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

March 31, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

April 30, 2026

Conditions
Chronic Low Back PainNegative Affectivity
Interventions
DRUG

Antidepressant

"The antidepressant treatment utilizes antidepressant medication to improve pain, function, and depression outcomes.~The Antidepressant Treatment History Form (ATHF) will be used to assess adequacy of any prior antidepressant medication treatment and to assist the decision regarding which antidepressant to start. A medication flowchart will help serve as a guideline throughout the drug selection and dosing determination. Weekly assessments completed by subjects will help determine response, tolerability, and necessity for dose adjustment or medication change."

OTHER

Enhanced Fear Avoidance Rehabilitation

The EFAR treatment utilizes physical therapy, pain education, and motivational messaging to improve pain, function, and depression outcomes. Subjects will engage in gradual exposure to exercises and activities they are apprehensive about, such as standing to wash dishes.

Trial Locations (3)

15206

UPMC Pain Medicine At Centre Commons, Pittsburgh

55905

Mayo Clinic, Rochester

02467

BWH Pain Management Center, Chestnut Hill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

collaborator

Mayo Clinic

OTHER

collaborator

Massachusetts General Hospital

OTHER

lead

Ajay Wasan, MD, Msc

OTHER

NCT04747314 - Treating Negative Affect in Low Back Pain Patients | Biotech Hunter | Biotech Hunter