Nonpharmacologic Pain Management in FQHC Primary Care Clinics

Chronic Pain Clinical Trial

— BeatPain Utah  

Official title:

Nonpharmacologic Pain Management in FQHC Primary Care Clinics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923334
• Other study ID #: IRB_00143493
• Status: Recruiting
• Phase: Phase 3
• Start date: November 4, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: June 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.)

Related Conditions & MeSH terms

• Chronic Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Duke University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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