NCT04923334

Nonpharmacologic Pain Management in FQHC Primary Care Clinics

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to improve pain management and reduce opioid reliance for patients with chronic back pain in Utah Federally-Qualified Health Centers (FQHCs). The study compares the effectiveness of nonpharmacologic pain treatments using telehealth to overcome access barriers. We will use automated EHR reminders for electronic referral to teleconsult services. Our project tests adaptive treatments and uses a hybrid type I design - focused on effectiveness outcomes while gathering implementation data to inform future efforts to scale effective strategies.

Detailed description

This randomized clinical trial compares the effectiveness of different strategies to provide efficacious nonpharmacologic interventions to patients with back pain seeking care in FQHCs throughout the state of Utah. The strategies evaluated are designed to overcome the barriers specific to rural and low income communities served by FQHC clinics through innovative use of telehealth resources. The randomized trial will randomize individual participants to one of two interventions strategies, one providing both a brief pain teleconsult with a 10-week telehealth physical therapy, the other uses an adaptive strategy - providing the brief pain teleconsult first, followed by the 10-week telehealth physical therapy only among those non-responsive to the brief teleconsult treatment. We will also evaluate outcomes related to the efforts to implement strategies in FQHC clinics in order to provide valuable information for future efforts to scale effective strategies into other low resource health care settings. Assessments will occur at baseline and after 12-, 26- and 52-weeks.

Conditions

• Low Back Pain
• Chronic Pain

Interventions

Type	Name	Description
BEHAVIORAL	Brief Pain Teleconsult	The Brief Pain Teleconsult intervention includes 2 sessions provided by a licensed physical therapist over about 1 week. The sessions focus on pain education from a biopsychosocial perspective that is designed to address negative pain appraisals and catastrophizing thoughts, providing advice to be active and engage in exercise and physical activity, and reassurance that activity is beneficial and safe.
BEHAVIORAL	Telehealth Physical Therapy	The Telehealth Physical Therapy intervention involves weekly telehealth sessions provided over 10 weeks. Telehealth Physical Therapy is provided by a licensed physical therapist. Key components of the intervention include reinforcing biopsychosocial education messages and developing an exercise and physical activity program using cognitive behavioral principles such as goal setting and positive reinforcement. Pain coping strategies including mindful breathing and progressive relaxation techniques will be included.

Timeline

• Start date: 2021-11-04
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2021-06-11
• Last updated: 2026-04-07

Locations

2 sites across 1 country: United States