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Active, Not Recruiting

NCT Number: NCT04923334

Nonpharmacologic Pain Management in FQHC Primary Care Clinics

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Low Back Pain Agnosia Back Pain Chronic Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Association of Utah Community Health, Salt Lake City, Utah, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Brief Pain Teleconsult

Behavioral

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.

Telehealth Physical Therapy

Behavioral

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.

Primary outcomes

  1. PEG-3

    Time frame: 12 weeks

    The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Item response options range from 0-10. The PEG-3 score is expressed as the mean of all item scores with higher scores indicating greater pain impact

Secondary outcomes

  1. Physical Function

    Time frame: baseline, 12-, 26- and 52-weeks

    The PROMIS short form 6b for physical function uses fixed items from the PROMIS physical function item bank to provide a T-score with population mean = 50 (sd=10).

  2. Sleep Disturbance

    Time frame: baseline, 12-, 26- and 52-weeks

    The PROMIS short form 6a for sleep disturbance uses fixed items from the PROMIS sleep disturbance item bank to provide a T-score with population mean = 50 (sd=10).

  3. Pain Catastrophizing

    Time frame: baseline, 12-, 26- and 52-weeks

    The PSC-6 is a short-form questionnaire evaluating an individual's negative cognitive-affective response to anticipated or actual pain

  4. Pain Self-Efficacy

    Time frame: baseline, 12-, 26- and 52-weeks

    The PSEQ-4 is a short form questionnaire evaluating an individual's confidence in performing activities despite pain

  5. Global Impression of Change

    Time frame: baseline, 12-, 26- and 52-weeks

    The single-item PGIC assesses participants' of change following treatment based on the question: "Since my treatment, my pain is…" with Likert scale response options ranging from (0) "very much worse" to (6) "very much improved".

  6. opioid use

    Time frame: across 52 week follow-up

    Prescription opioid use across the 52-week follow-up will be examined from EHR noting number of prescriptions and days of use.

  7. PEG-3

    Time frame: baseline, 26- and 52-weeks

    The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Item response options range from 0-10. The PEG-3 score is expressed as the mean of all item scores with higher scores indicating greater pain impact

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Duke University

Registry information

Acronym: BeatPain Utah

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2021
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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