The BEST Trial: Biomarkers for Evaluating Spine Treatments

Completed · Phase 4

Conditions studied: Chronic Low-back Pain

In brief

The BEST Trial (Biomarkers for Evaluating Spine Treatments) is a National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)-sponsored clinical trial being conducted through the NIH Helping to End Addiction Long-term (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 the optimal treatment or combination of treatments based on patient features and response to the initial 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.

Key facts

Study ID

NCT05396014

Run by

University of North Carolina, Chapel Hill

People needed

1014

Starts

2022-09-12

Expected to finish

2024-10-22

Last updated by the study team

2025-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 prior to the Run-in period
• 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:
• o Completion of two Run-in study information modules prior to period 1 randomization (Visit 0)
• Low-back pain more severe than pain in other parts of the body
• Available to complete the full study protocol (approximately 9 months)

You may not qualify 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, psoriatic arthritis, or lupus
• 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

Where it is running

• Stanford University — Redwood City, California, United States
• University of California, San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Kansas Health System — Kansas City, Kansas, United States
• Massachusetts General Hospital/Brigham Women's Hospital, Harvard Medical School — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of North Carolina Hospital Pain Management Clinic — Chapel Hill, North Carolina, United States
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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