RecruitingPhase 3NCT04923334

Nonpharmacologic Pain Management in FQHC Primary Care Clinics

Sponsor

University of Utah

Enrollment

500 participants

Start Date

Nov 4, 2021

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Low Back Pain

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

Able to communicate in English or Spanish
Age between 18-80
Visit with an FQHC provider (in-person or via telehealth) in past 90 days
Back pain has been an ongoing problem for at least the past 3 months, and has been a problem on at least half the days in the past 6 months
Access to resources necessary to receive telehealth sessions (phone or 2-way video)

Exclusion Criteria5

Currently pregnant
Currently involved in active substance use disorder treatment (other than peer support groups, AA, etc.)
History of spine surgery in past 6 months
Has a condition restricting participation in physical activity (i.e., unable to ambulate independently (with or without assistive device) for at least 5 minutes.
Reason for back pain is a fracture or non-musculoskeletal condition (i.e., spinal tumor, inflammatory disorder, etc.)

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Interventions

BEHAVIORALBrief 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.

BEHAVIORALTelehealth 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.