Nonpharmacologic Pain Management for Chronic Back Pain
(BeatPain Utah Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Utah
Disqualifiers: Pregnancy, Substance use treatment, Spine surgery, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on non-drug treatments for back pain, so it's best to ask the trial organizers for more details.
What data supports the effectiveness of the treatment Brief Pain Teleconsult for chronic back pain?
Research shows that using telehealth for physical therapy and pain management can be effective for chronic low back pain, as it helps overcome access barriers and provides similar benefits to in-person care. Videoconferencing technology has been successfully used to deliver integrated cognitive-behavioral and physical therapy, which is effective for managing chronic pain.
12345Is telehealth physical therapy safe for managing chronic back pain?
Research indicates that telehealth physical therapy, including group teletherapy and videoconferencing, is generally safe for managing chronic pain, including chronic back pain.
12467How is the Brief Pain Teleconsult and Telehealth Physical Therapy treatment different from other treatments for chronic back pain?
This treatment is unique because it uses telehealth technology to deliver physical therapy and pain management remotely, allowing patients to receive care from home. It combines cognitive-behavioral strategies with physical therapy, providing a comprehensive approach without the need for medication.
4891011Eligibility Criteria
This trial is for adults aged 18-70 with chronic back pain, who have access to telehealth resources and can communicate in English or Spanish. They must have seen an FQHC provider recently but cannot join if they've had recent spine surgery, are pregnant, have non-musculoskeletal causes of back pain, or severe physical restrictions.Inclusion Criteria
Visited with an FQHC provider (in-person or via telehealth) in the past 90 days
Access to resources necessary to receive telehealth sessions (phone or 2-way video)
I can communicate in English or Spanish.
+4 more
Exclusion Criteria
I cannot walk on my own for at least 5 minutes, even with help.
My back pain is due to a fracture or a condition like a spinal tumor.
I have had spine surgery within the last 6 months.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Brief Pain Teleconsult
Participants receive a brief teleconsult intervention to manage pain
1-12 weeks
Telehealth sessions
Telehealth Physical Therapy
Non-responders to the initial teleconsult receive a 10-week telehealth physical therapy intervention
10 weeks
Telehealth sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
52 weeks
Assessments at 12, 26, and 52 weeks
Participant Groups
The study tests non-drug treatments for chronic back pain via telehealth to reduce opioid use. It compares telehealth physical therapy and brief pain consultations using electronic health record reminders. The focus is on treatment effectiveness while also collecting data on implementation.
2Treatment groups
Experimental Treatment
Group I: Brief Pain Teleconsult plus Telehealth Physical TherapyExperimental Treatment2 Interventions
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.
Group II: Brief Pain TeleconsultExperimental Treatment2 Interventions
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.
Brief Pain Teleconsult is already approved in United States for the following indications:
🇺🇸 Approved in United States as Brief Pain Teleconsult for:
- Chronic low back pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Association of Utah Community HealthSalt Lake City, UT
The University of Utah Healthcare SystemSalt Lake City, UT
Loading ...
Who Is Running the Clinical Trial?
University of UtahLead Sponsor
Duke UniversityCollaborator
References
In-Clinic Versus Web-Based Multidisciplinary Exercise-Based Rehabilitation for Treatment of Low Back Pain: Prospective Clinical Trial in an Integrated Practice Unit Model. [2021]The recent onset of the COVID-19 pandemic has highlighted the need to reduce barriers to access physical therapy and associated care through the use of web-based programs and telehealth for those seeking treatment for low back pain (LBP). Despite this need, few studies have compared the effectiveness of clinic-based versus web-based or telehealth services.
Outcomes of Telehealth Physical Therapy Provided Using Real-Time, Videoconferencing for Patients With Chronic Low Back Pain: A Longitudinal Observational Study. [2022]To describe the feasibility of an evidence-based physical therapy (PT) program for persons with chronic low back pain (LBP) originally designed for in-person delivery, adapted for telehealth using videoconferencing.
A physical therapist and nurse practitioner model of care for chronic back pain using telehealth: Diagnostic and management concordance. [2022]Virtual care using videoconference links between urban-based physical therapists and nurse practitioners in rural primary care may overcome access challenges and enhance care for rural and remote residents with chronic low back disorders (CBD). The purpose of this study was to evaluate the concordance of this new model of care with two traditional models.
Tele-pain management: use of videoconferencing technology in the delivery of an integrated cognitive-behavioral and physical therapy group intervention. [2022]Chronic pain has been recognized as a highly prevalent problem, and interdisciplinary treatments have been shown to be effective in the treatment of chronic pain. An integrated cognitive-behavioral and physical therapy group protocol has been developed and then implemented at remote sites using videoconferencing technology to provide pain management for veterans. The treatment model is summarized and recommendations are made for addressing challenges in implementing this type of treatment via videoconferencing.
The Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial. [2022]Internet-based treatment programs present a solution for providing access to pain management for those unable to access clinic-based multidisciplinary pain programs. Attrition from internet interventions is a common issue. Clinician-supported guidance can be an important feature in web-based interventions; however, the optimal level of therapist guidance and expertise required to improve adherence remains unclear.
Online group pain management for chronic pain: Preliminary results of a novel treatment approach to teletherapy. [2021]This pilot study was designed to determine the feasibility, tolerability, safety, and efficacy of group teletherapy for persons with chronic pain. The aim was to present preliminary outcomes of an open trial of group cognitive behavioural therapy (CBT) teletherapy compared with an in-person chronic pain patient group.
Identifying Perceptions, Experiences, and Recommendations of Telehealth Physical Therapy for Patients With Chronic Low Back Pain: A Mixed Methods Survey. [2022]To describe concerns, advantages, and disadvantages encountered in an evidence-based physical therapy (PT) program for persons with chronic low back pain (CLBP) delivered by telehealth.
Nonpharmacological treatment of pain in rheumatic diseases and other musculoskeletal pain conditions. [2022]Pain is a complex phenomenon affected by biological, psychological, and social factors. Treatment of pain is most effective when using a multidisciplinary approach consisting of a careful selection of pharmacological and non-pharmacological interventions based upon disease factors, pain characteristics, psychological coping abilities, and lifestyle factors. In this review we focus on research-based evidence for non-pharmacological intervention including psychological intervention, physical exercise, patient education, and complementary approaches for pain management for patients with rheumatic diseases and common musculoskeletal pain conditions, such as low back pain. The vast majority of research studies on chronic pain conditions are focused on adults but pediatric studies are also reviewed wherever possible, to give the reader a more inclusive view of non-pharmacological approaches for pain management across the lifespan.
[The non-pharmacological management of chronic pain]. [2017]Pain management is not limited to the putting in place of pharmacological, surgical, physiotherapy or psychological strategies. Non-pharmacological therapies can also be proposed, notably in relation to chronic pain. Appreciated by patients and developed by caregivers, they require appropriate regulatory guidelines and specific training in order for them to be implemented safely.
[Nonpharmacological pain therapy for chronic pain]. [2019]The treatment of chronic pain should be a multimodal combination of pharmacological and nonpharmacological components. This article describes some of the nonpharmacological treatment options and their evidence (e.g. physical therapy, massage, manual therapy, electrotherapy, acupuncture and music therapy). The evidence for an empirically detected effectiveness of all these forms of therapy is not very high and often inconsistent. Nevertheless, this does not mean that these forms of treatment should not be used but that they should be selected on an individual basis to improve the well-being of patients by being adjusted to their needs.
Identifying Predictors of Recommendations for and Participation in Multimodal Nonpharmacological Treatments for Chronic Pain Using Patient-Reported Outcomes and Electronic Medical Records. [2021]High-quality chronic pain care emphasizes multimodal treatments that include medication and nonpharmacological treatments. But it is not clear which patients will participate in nonpharmacological treatments, such as physical therapy or mental health care, and previous research has shown conflicting evidence.