Study Comparing Non-Surgical Treatments for Chronic Low Back Pain in Veterans Including Internet-Based Programs, Physical Therapy, Yoga, Spinal Manipulation, and Behavioral Therapy

What this Trial Is About

Chronic low back pain cLBP is a common and costly condition, especially among US Veterans, with about half experiencing chronic pain. This study aims to find the best non-surgical and non-drug treatments for cLBP using a two-step randomized design. The first step compares continued care and active monitoring CCAM, an internet-based pain self-management program called Pain EASE, and an enhanced physical therapy program combining Pain EASE with personalized exercises. Veterans who do not improve significantly after Step 1 or want more treatment enter Step 2, where they are randomized to yoga, spinal manipulation therapy SMT, or cognitive behavioral therapy CBT, allowing participants to exclude one option based on their preference. In Step 1, participants receive either CCAM, Pain EASE, or enhanced physical therapy with up to 8 sessions guided by a physical therapist. CCAM involves usual care and monitoring without new treatments like CBT, chiropractic, or yoga. Step 2 treatments last about 3 months with up to 10 sessions therapist-led CBT, chiropractor-led SMT, or weekly 60-minute yoga classes plus home practice. These interventions reflect current guidelines and patient preferences and are designed to be accessible and safe for Veterans. Participants will be followed for one year after their final treatment to assess lasting effects. Researchers will measure pain interference using the Brief Pain Inventory at 3 months as the main outcome, along with other assessments like pain severity, physical function, mood, sleep, fatigue, and quality of life. The study will also track treatment adherence, patient and provider acceptance, costs, and healthcare use. A total of 2529 Veterans across 20 centers will participate, helping to guide the best approaches to managing chronic low back pain within the VA healthcare system.

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response