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COMPLETED
NCT04747314
PHASE2

Treating Negative Affect in Low Back Pain Patients

Sponsor: Ajay Wasan, MD, Msc

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

308

Start Date

2021-03-31

Completion Date

2024-12-20

Last Updated

2026-08-25

Healthy Volunteers

No

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 standardized physical and/or occupational therapy fear avoidance approaches, including 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.

Locations (3)

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