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Nonpharmacologic Pain Management in FQHC Primary Care Clinics

Nonpharmacologic Pain Management in FQHC Primary Care Clinics

Recruiting
18-80 years
All
Phase 3

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • 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.)

Study details
    Low Back Pain
    Chronic Pain

NCT04923334

University of Utah

24 June 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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