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Nonpharmacologic Pain Management for Chronic Back Pain (BeatPain Utah Trial)

Phase 3

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to communicate in English or Spanish

Age between 18-80

Must not have

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.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12-, 26- and 52-weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether non-drug pain treatments can help people with chronic back pain, and whether using telehealth can make these treatments more accessible.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve nonpharmacologic methods like teleconsults and physical therapy through telehealth services, typical drug side effects are not expected; however, participants may experience discomfort or fatigue related to physical therapy exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can communicate in English or Spanish.

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I am between 18 and 80 years old.

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I have had back pain for at least 3 months, often in the last 6 months.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot walk on my own for at least 5 minutes, even with help.

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My back pain is due to a fracture or a condition like a spinal tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12-, 26- and 52-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12-, 26- and 52-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12-, 26- and 52-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Global Impression of Change

PEG-3

Pain Catastrophizing

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Telehealth Physical Therapy

2020

N/A

~130

0 / 6Eligibility criteria met