Low Back PainPhase 3BeatPain UtahNCT04923334
Nonpharmacologic Pain Management in FQHC Primary Care Clinics
A Phase 3 study testing Brief Pain Teleconsult and Telehealth Physical Therapy in people with Low Back Pain and Chronic Pain, run by University of Utah at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain, Chronic Pain
- What is being tested?
- Brief Pain Teleconsult and Telehealth Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2021to 31 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Association of Utah Community Health
Salt Lake City, Utah, 84106
The University of Utah Healthcare System
Salt Lake City, Utah, 84108
About this study
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.
Read the detailed 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.
- Conditions
- Low Back Pain, Chronic Pain
- Being tested
- Brief Pain Teleconsult, Telehealth Physical Therapy
- Keywords
- Telehealth, Pain Management, Physical Therapy, Health Disparities
- Medical subject headings
- Low Back Pain, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Pain TeleconsultBehavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Pain Teleconsult | Experimental | 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. Receives: Behavioral: Brief Pain Teleconsult; Behavioral: Telehealth Physical Therapy |
| Brief Pain Teleconsult plus Telehealth Physical Therapy | Experimental | 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. Receives: Behavioral: Brief Pain Teleconsult; Behavioral: Telehealth Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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".
Measured: 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.
Measured: 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
Measured: baseline, 26- and 52-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start4 Nov 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a clinical trial testing adaptive interventions. All participants receive the Brief Pain Teleconsult in Phase I. We will randomly assign participants with 1:1 distribution to also receive 10-week Telehealth Physical Therapy during Phase I. All participants are re-assessed at 12 weeks and responder status is determined. For participants not receiving Telehealth Physical Therapy in Phase I, further treatment is based on responder status. Responders receive no further treatment. Non-responders receive the 10-week Telehealth Physical Therapy in Phase II. Participants randomized to Telehealth PT in Phase I receive no further treatment. Long-term assessments occur 26 and 52 weeks after randomization.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Principal investigator, Julie Fritz, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923334
- Sponsor's protocol ID
- IRB_00143493
- Acronym
- BeatPain Utah
- Status last verified
- Apr 2026
- First submitted
- 1 Jun 2021
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared through the HEAL initiative at NIH
Publications
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.
PubMed 36351735Fritz 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.
PubMed 38183154Fritz 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.
PubMed 38706872Fritz JM, Gibson B, Wetter DW, Fiol GD, Solis VH, 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. Res Sq [Preprint]. 2023 Sep 11:rs.3.rs-3267087. doi: 10.21203/rs.3.rs-3267087/v1.
PubMed 37790359
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonpharmacologic Pain Management in FQHC Primary Care Clinics
- ClinicalTrials.gov ID
- NCT04923334
- Acronym / sponsor ID
- BeatPain Utah / IRB_00143493
- Conditions
- Low Back Pain, Chronic Pain
- Keywords
- Telehealth, Pain Management, Physical Therapy, Health Disparities
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study design is a clinical trial testing adaptive interventions. All participants receive the Brief Pain Teleconsult in Phase I. We will randomly assign participants with 1:1 distribution to also receive 10-week Telehealth Physical Therapy during Phase I. All participants are re-assessed at 12 weeks and responder status is determined. For participants not receiving Telehealth Physical Therapy in Phase I, further treatment is based on responder status. Responders receive no further treatment. Non-responders receive the 10-week Telehealth Physical Therapy in Phase II. Participants randomized to Telehealth PT in Phase I receive no further treatment. Long-term assessments occur 26 and 52 weeks after randomization.
| Arm | Type | Receives |
|---|---|---|
| Brief Pain Teleconsult | Experimental | Behavioral: Brief Pain Teleconsult, Behavioral: Telehealth Physical TherapyParticipants 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. |
| Brief Pain Teleconsult plus Telehealth Physical Therapy | Experimental | Behavioral: Brief Pain Teleconsult, Behavioral: Telehealth Physical TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Pain TeleconsultThe 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. | Behavioural | Brief Pain Teleconsult, Brief Pain Teleconsult plus Telehealth Physical Therapy |
| Telehealth Physical TherapyThe 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. | Behavioural | Brief Pain Teleconsult, Brief Pain Teleconsult plus Telehealth Physical Therapy |
Primary outcome
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
7 secondary outcomes
Physical Function
Time frame: baseline, 12-, 26- and 52-weeks
Sleep Disturbance
Time frame: baseline, 12-, 26- and 52-weeks
Pain Catastrophizing
Time frame: baseline, 12-, 26- and 52-weeks
Pain Self-Efficacy
Time frame: baseline, 12-, 26- and 52-weeks
Global Impression of Change
Time frame: baseline, 12-, 26- and 52-weeks
opioid use
Time frame: across 52 week follow-up
PEG-3
Time frame: baseline, 26- and 52-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 36351735Fritz 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.
- Background: PubMed 38183154Fritz 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.
- Background: PubMed 38706872Fritz 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.
- Derived from this study: PubMed 37790359Fritz JM, Gibson B, Wetter DW, Fiol GD, Solis VH, 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. Res Sq [Preprint]. 2023 Sep 11:rs.3.rs-3267087. doi: 10.21203/rs.3.rs-3267087/v1.
- Individual participant dataSharing planned: Yes. IPD will be shared through the HEAL initiative at NIH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brief Pain Teleconsult and Telehealth Physical Therapy in people with Low Back Pain and Chronic Pain, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PEG-3 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923334, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.