Overview

The BEST Trial: Biomarkers for Evaluating Spine Treatments

Status:
Not yet recruiting
Trial end date:
2023-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Treatments:
Duloxetine Hydrochloride
Criteria
Inclusion Criteria:

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)

Exclusion Criteria:

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