Chronic Pain Clinical Trial
— BeatPain UtahOfficial title:
Nonpharmacologic Pain Management in FQHC Primary Care Clinics
Verified date | June 2024 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | May 31, 2026 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
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.) |
Country | Name | City | State |
---|---|---|---|
United States | Association of Utah Community Health | Salt Lake City | Utah |
United States | The University of Utah Healthcare System | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | Duke University |
United States,
Fritz JM, Del Fiol G, Gibson B, Wetter DW, Solis V, Bennett E, Thackeray A, Goode A, Lundberg K, Romero A, Ford I, Stevens L, Siaperas T, Morales J, Yack M, Greene T. BeatPain Utah: study protocol for a pragmatic randomised trial examining telehealth strategies to provide non-pharmacologic pain care for persons with chronic low back pain receiving care in federally qualified health centers. BMJ Open. 2022 Nov 9;12(11):e067732. doi: 10.1136/bmjopen-2022-067732. — View Citation
Fritz JM, Ford I, George SZ, Vinci de Vanegas L, Cope T, Burke CA, Goode AP. Telehealth delivery of physical therapist-led interventions for persons with chronic low back pain in underserved communities: lessons from pragmatic clinical trials. Front Pain Res (Lausanne). 2024 Apr 19;5:1324096. doi: 10.3389/fpain.2024.1324096. eCollection 2024. — View Citation
Fritz JM, Gibson B, Wetter DW, Del Fiol G, Solis V, Ford I, Lundberg K, Thackeray A. Use of implementation mapping in the planning of a hybrid type 1 pragmatic clinical trial: the BeatPain Utah study. Implement Sci Commun. 2024 Jan 5;5(1):3. doi: 10.1186/s43058-023-00542-z. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PEG-3 | 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 | 12 weeks | |
Secondary | Physical Function | 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). | baseline, 12-, 26- and 52-weeks | |
Secondary | Sleep Disturbance | 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). | baseline, 12-, 26- and 52-weeks | |
Secondary | Pain Catastrophizing | The PSC-6 is a short-form questionnaire evaluating an individual's negative cognitive-affective response to anticipated or actual pain | baseline, 12-, 26- and 52-weeks | |
Secondary | Pain Self-Efficacy | The PSEQ-4 is a short form questionnaire evaluating an individual's confidence in performing activities despite pain | baseline, 12-, 26- and 52-weeks | |
Secondary | Global Impression of Change | 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". | baseline, 12-, 26- and 52-weeks | |
Secondary | opioid use | Prescription opioid use across the 52-week follow-up will be examined from EHR noting number of prescriptions and days of use. | across 52 week follow-up | |
Secondary | PEG-3 | 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 | baseline, 26- and 52-weeks |
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