Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM) for Chronic Lower Back Pain (CLBP)

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Washington, Seattle, WA
Chronic Lower Back Pain (CLBP)+2 More
Evidence-Based Exercise and Manual Therapy (EBEM) - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The BEST Trial (Biomarkers for Evaluating Spine Treatments) is a NIAMS-sponsored clinical trial being conducted through the NIH HEAL Initiative's Back Pain Consortium (BACPAC) Research Program. The primary objective of this trial is to inform a precision medicine approach to the treatment of Chronic Low-Back Pain by estimating an algorithm for optimally assigning treatments based on an individual's phenotypic markers and response to treatment. Interventions being evaluated in this trial are: (1) enhanced self-care (ESC), (2) acceptance and commitment therapy (ACT), (3) evidence-based exercise and manual therapy (EBEM), and (4) duloxetine.

Eligible Conditions

  • Chronic Lower Back Pain (CLBP)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Baseline, 24 Weeks

Baseline, 24 Weeks
Change in Anxiety Score
Change in Depression Score
Change in Pain Interference
Change in Patient-Reported Pain Intensity and Interference Score
Change in Physical Function
Change in Sleep Disturbance
Change in Sleep Duration
Incidence of Any Opioid Use

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)
1 of 4
Treatment Period 1: Duloxetine
1 of 4
Treatment Period 1: Acceptance and Commitment Therapy (ACT)
1 of 4
Treatment Period 1: Enhanced Self-Care (ESC)
1 of 4
Active Control

820 Total Participants · 4 Treatment Groups

Primary Treatment: Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM) · No Placebo Group · Phase 4

Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)
Behavioral
ActiveComparator Group · 1 Intervention: Evidence-Based Exercise and Manual Therapy (EBEM) · Intervention Types: Behavioral
Treatment Period 1: Duloxetine
Drug
ActiveComparator Group · 1 Intervention: Duloxetine · Intervention Types: Drug
Treatment Period 1: Acceptance and Commitment Therapy (ACT)
Behavioral
ActiveComparator Group · 1 Intervention: Acceptance and Commitment Therapy (ACT) · Intervention Types: Behavioral
Treatment Period 1: Enhanced Self-Care (ESC)
Behavioral
ActiveComparator Group · 1 Intervention: Enhanced Self-Care (ESC) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 24 weeks
Closest Location: University of Washington · Seattle, WA
Photo of university of washington 1Photo of university of washington 2Photo of university of washington 3
1993First Recorded Clinical Trial
1 TrialsResearching Chronic Lower Back Pain (CLBP)
629 CompletedClinical Trials

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,348 Previous Clinical Trials
3,907,786 Total Patients Enrolled
1 Trials studying Chronic Lower Back Pain (CLBP)
21 Patients Enrolled for Chronic Lower Back Pain (CLBP)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
443 Previous Clinical Trials
1,068,711 Total Patients Enrolled
3 Trials studying Chronic Lower Back Pain (CLBP)
1,160 Patients Enrolled for Chronic Lower Back Pain (CLBP)
Anna Hoffmeyer, MPHStudy DirectorUNC Chapel Hill
Kevin Anstrom, PhDPrincipal InvestigatorUNC Chapel Hill
5 Previous Clinical Trials
894 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to receive study-related messages and survey links via email.
You must be between the ages of 18 and 50 years old.
You have low-back pain for at least 3 months and occurring on at least half the days in the past 6 months.
You are eligible to receive at least three of the four study interventions and willing to receive any intervention for which they are eligible.
You have a PEG score of 4 or higher at two time points: 1) screening prior to the Run-in period and 2) screening prior to baseline (Visit 0).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.