Status:
COMPLETED
The BEST Trial: Biomarkers for Evaluating Spine Treatments
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
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 per...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
September 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2024
Estimated Enrollment :
1014 Patients enrolled
Trial Details
Trial ID
NCT05396014
Start Date
September 12 2022
End Date
October 22 2024
Last Update
July 23 2025
Active Locations (12)
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1
Stanford University
Redwood City, California, United States, 94063
2
University of California, San Diego
San Diego, California, United States, 92037
3
University of California, San Francisco
San Francisco, California, United States, 94158
4
University of Kansas Health System
Kansas City, Kansas, United States, 66160