Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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 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.
Full 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 period. Upon completion of the run-in period, participant eligibility will be reassessed based on adherence to study protocol. Participants who no longer meet eligibility criteria will be considered screen failures and discontinued from the study.
All participants will undergo phenotyping assessments at Visit 0, 1 and 2 corresponding to baseline, the end of the first 12-week intervention period, and the end of the second 12-week intervention period, respectively. A subset of participants will undergo additional phenotyping, consisting of a more comprehensive set of phenotyping assessments, at the same visits.
Pain, Enjoyment of Life, and General Activity (PEG) and Patient Global Impressions Scale (PGIC) will be assessed at 6 weeks (midpoint of intervention period one), 12 weeks (Visit 1), 18 weeks (midpoint of intervention period two), 24 weeks (Visit 2), and 36 weeks post-baseline (12 weeks after intervention period two). Basic safety assessments will also be performed at these time points to assess participant tolerability to their current study intervention(s). Patients who are unable to tolerate their assigned study treatment will be educated on how to safely discontinue their current treatment plan but will otherwise remain in the study.
Enrollment
Sex
Ages
Volunteers
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:
Any condition that, in the opinion of the investigator, would preclude the patient from being able to safely participate in in the trial
Primary purpose
Allocation
Interventional model
Masking
1,014 participants in 4 patient groups
Loading...
Central trial contact
Mirela Scott; Rachel Goolsby
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal