A Phase 3 interventional study of Brief Pain Teleconsult and Telehealth Physical Therapy in Low Back Pain and Chronic Pain, sponsored by University of Utah. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by University of Utah · Phase 3, Interventional, and Treatment
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.
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.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's planned enrollment of 500 is above the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
Participants randomized to Brief Pain Teleconsult will receive the brief teleconsult intervention in Phase 1 (1-12 weeks) Responder status to the Phase 1 treatment will be examined at the 12 week assessment. Participants determined to be non-responders will receive the Telehealth Physical Therapy intervention. Responders receive no additional treatment.
Behavioral: Brief Pain Teleconsult · Behavioral: Telehealth Physical Therapy
Participants randomized to Brief Pain Teleconsult plus Telehealth Physical Therapy will receive the brief teleconsult intervention in Phase 1 followed by the 10-week physical therapy intervention. No additional treatment is provided after the 12 week assessment.
Behavioral: Brief Pain Teleconsult · Behavioral: Telehealth Physical Therapy
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.
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.
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
Time frame: 12 weeks
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).
Time frame: baseline, 12-, 26- and 52-weeks
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).
Time frame: baseline, 12-, 26- and 52-weeks
Pain Catastrophizing
The PSC-6 is a short-form questionnaire evaluating an individual's negative cognitive-affective response to anticipated or actual pain
Time frame: baseline, 12-, 26- and 52-weeks
Pain Self-Efficacy
The PSEQ-4 is a short form questionnaire evaluating an individual's confidence in performing activities despite pain
Time frame: baseline, 12-, 26- and 52-weeks
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".
Time frame: baseline, 12-, 26- and 52-weeks
opioid use
Prescription opioid use across the 52-week follow-up will be examined from EHR noting number of prescriptions and days of use.
Time frame: across 52 week follow-up
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
Time frame: baseline, 26- and 52-weeks
Plan to share: Yes — IPD will be shared through the HEAL initiative at NIH
Supporting information: Study protocol, Sap
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of Utah