Phase 4
N=805
The BEST Trial: Biomarkers for Evaluating Spine Treatments
Chronic Low-back Pain
Bottom Line
View on ClinicalTrials.gov: NCT05396014 ↗Enrolled (actual)
805
Serious AEs
2.3%
Results posted
Jul 2025
Primary outcome: Primary: Patient-Reported Pain Intensity and Interference Score — 4.16; 3.86; 3.57; 4.72 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Enhanced Self-Care (ESC) (Behavioral); Acceptance and Commitment Therapy (ACT) (Behavioral); Evidence-Based Exercise and Manual Therapy (EBEM) (Behavioral); Duloxetine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-Reported Pain Intensity and Interference Score |
4.16; 3.86; 3.57; 4.72 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System-Pain Interference |
59.03; 58.48; 57.61; 60.13 | — |
| SECONDARY Number of Participants Self-Reporting Taking Opioids |
8; 6; 8; 9 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System- Physical Function |
42.14; 43.32; 43.11; 41.18 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Score |
49.22; 47.83; 49.03; 50.19 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety |
49.73; 48.15; 49.14; 50.43 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - Sleep Disturbance |
52.61; 51.45; 51.91; 53.21 | — |
| SECONDARY Sleep Duration |
6.82; 6.74; 6.73; 6.67 | — |
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 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.
Eligibility 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 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 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, 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
Data sourced from ClinicalTrials.gov (NCT05396014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.