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