Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Jeffrey Lotz, PhDConor O'Neill
Headshot of Jeffrey Lotz
Jeffrey Lotz

Description

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.

Details

Each participant will complete an initial screening call and enrollment visit, followed by a 2-week run-in period, two consecutive 12-week treatment periods, and a 12-week post-treatment follow-up period. Upon completion of the run-in period, participant eligibility will be reassessed based on their Pain, Enjoyment of Life, and General Activity (PEG) score and adherence to study protocol. Participants who no longer meet eligibility criteria will be considered screen failures and discontinued from the study. All participants will undergo phenotyping assessments at Visit 0, 1 and 2 corresponding to baseline, the end of the first 12-week intervention period, and the end of the second 12-week intervention period, respectively. A subset of participants will undergo additional phenotyping, consisting of a more comprehensive set of phenotyping assessments, at the same visits. Pain, Enjoyment of Life, and General Activity (PEG) and Patient Global Impressions Scale (PGIC) will be assessed at 6 weeks (midpoint of intervention period one), 12 weeks (Visit 1), 18 weeks (midpoint of intervention period two), 24 weeks (Visit 2), and 36 weeks post-baseline (12 weeks after intervention period two). Basic safety assessments will also be performed at these time points to assess participant tolerability to their current study intervention(s). Patients who are unable to tolerate their assigned study treatment will be educated on how to safely discontinue their current treatment plan but will otherwise remain in the study. The secondary objectives are to (a) estimate Dynamic Treatment Regimes (DTRs) that optimally balance multiple outcomes, taking into account participant preferences for outcomes including pain intensity, pain interference, physical function, opioid use, depression, anxiety, sleep duration and sleep disturbance, (b) estimate DTRs that incorporate additional phenotypic markers (i.e., deep phenotyping) collected on a sub-set of participants, and (c) assess whether effectiveness is sustained based on outcomes collected 24 weeks after randomization to the second treatment.

Keywords

Chronic Low-back Pain, Pain, Back Pain, Low Back Pain, Duloxetine Hydrochloride, Enhanced Self-Care (ESC), Acceptance and Commitment Therapy (ACT), Evidence-Based Exercise and Manual Therapy (EBEM), Duloxetine

Eligibility

You can join if…

Open to people ages 18 years and up

To be eligible, an individual must meet all of the following inclusion criteria:

  • Ability to read and understand English
  • Provision of signed and dated informed consent form(s)
  • Willing and able to receive study-related messages and survey links via email
  • Willing and able to receive study-related phone calls
  • Age 18 years old or older
  • Low-back pain for at least 3 months and occurring on at least half the days in the past 6 months
  • Contraindicated to no more than one of the study interventions at the time of eligibility assessment(s)
  • Eligible to receive at least three of the four study interventions and willing to receive any intervention for which they are eligible
  • A PEG score 4 or higher at two time points: 1) screening prior to the Run-in period and 2) screening prior to baseline (Visit 0)
  • Willing and able to undergo required phenotyping
  • Regular reliable access to an internet-enabled device such as a smart phone, tablet, or laptop computer
  • Meet Run-in period engagement eligibility criteria:
  • Completion of two Run-in study information modules
  • Response to 10 of 14 texts/emails
  • Low-back pain more severe than pain in other parts of the body
  • Available to complete the full study protocol (approximately 9 months)

You CAN'T join if...

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Pregnant at the time of Visit 0 (Baseline)
  • Affirmative participant response to any of the following conditions:
  • Progressive neurodegenerative disease
  • History of discitis osteomyelitis (spine infection) or spine tumor
  • History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, or psoriatic arthritis, lupus or other autoimmune disorder
  • History of cauda equina syndrome or spinal radiculopathy with functional motor deficit (strength <4/5 on manual motor testing)
  • Diagnosis of any vertebral fracture in the last 6 months
  • Osteoporosis requiring pharmacologic treatment other than vitamin D, calcium supplements, or bisphosphonates.
  • History of any bone-related cancer or cancer that metastasized to the bone
  • Currently in treatment for any non-skin cancer or plan to start non-skin cancer treatment in the next 12 months
  • History of any non-skin cancer treatment in the last 24 months
  • Visual or hearing difficulties that would preclude participation
  • Uncontrolled drug/alcohol addiction
  • Individuals actively pursuing disability or workers compensation or involved in active personal injury-related litigation
  • Currently participating in another interventional pain study
  • Any condition that, in the opinion of the investigator, would preclude the patient from being able to safely participate in in the trial

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94158 United States
  • Stanford University accepting new patients
    Redwood City California 94063 United States

Lead Scientists at UCSF

  • Jeffrey Lotz, PhD
    Jeffrey C. Lotz, PhD, holds the David S. Bradford, MD, Endowed Chair in Orthopaedic Surgery and vice chair for research. He has earned several awards for spine research, and serves as a deputy editor for the journal Spine.
  • Conor O'Neill

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
University of North Carolina, Chapel Hill
ID
NCT05396014
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 820 study participants
Last Updated