Selecting Effective Combinations of Treatment for Low Back Pain

Back pain is the #1 contributor to disability in the United States (US), and second only to
hearing problems as a reason for new Veteran disability compensation. The societal burden of
back pain is driven mainly by chronic low back pain (CLBP), defined as low back pain
persisting for 3 months. Since most individual treatments for CLBP have only small effects on
functional recovery, combining CLBP treatments has recently been recommended as a priority
area for research. However, few prior studies of CLBP have been properly designed to evaluate
the effects of treatment combinations. Large effects on functional recovery from CLBP may
require combining interventions that each target different points on a theoretical pathway to
functional recovery. Procedural treatments for CLBP aim primarily to address early stages in
the pathway to functional recovery, such as problems with the lumbar spinal structures or low
back pain itself. In contrast, behavioral interventions for CLBP generally have effects not
only on pain itself, but also work by mitigating the degree to which the sensation of low
back pain impacts function, well-being, and quality of life. These represent later stages in
the pathway to functional recovery from CLBP. Combining procedural and behavioral treatments
may have great potential for achieving large magnitude treatment effects for CLBP in
Veterans.

The proposed research uses an innovative application of the 2 x 2 factorial randomized
controlled trial (RCT) design to examine the individual and combined effects of 1) lumbar
medial branch nerve radiofrequency ablation (LRFA), a commonly used procedural intervention
to target low back pain severity, and 2) a novel video telehealth tablet- and personal
computer (PC)-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy
program ("AcTIVE-CBT"), a behavioral intervention designed primarily to target functional
limitations both secondary to, and independent of, improvements in pain. The LRFA treatment
to be used in the proposed study addresses the major patient selection, procedural/technical,
methodologic and reporting limitations of prior studies. AcTIVE-CBT addresses problems with
Veteran access and compliance associated with conventional cognitive behavioral therapy (CBT)
delivered in clinic, and uses currently available activity tracking technology to better
promote activity and behavior change as compared to conventional CBT. This pilot RCT involves
recruitment of up to 30 Veterans with CLBP who will be followed to evaluate functional
recovery for up to 3 months, to reach a goal of 20 Veterans completing the 3-month primary
outcome. The primary outcome is participant-reported back-related functional limitations
(mobility and ADLs) at 3 months, as measured by the validated Roland-Morris Disability
Questionnaire. Secondary outcomes include activity tracker-assessed step counts, back pain
intensity, reduction in opioid use, and quality of life. The investigators hypothesize that
1) each individual treatment will result in improvements in back-related functional
limitations and secondary outcomes compared to control, and 2) combined treatment will
produce greater treatment effects than each of the individual treatments alone. Although both
the LRFA and AcTIVE-CBT treatment arms are innovations on their own, the most unique aspect
of the proposed study is the use of the factorial RCT design to examine whether 'stacking'
disparate CLBP treatments can result in greater treatment effects than that of each treatment
alone. Although the proposed pilot study is unlikely to definitively address whether these
treatments alone or in combination have significant effects on functional recovery, it will
produce valid effect size estimates that will inform a future large-scale multicenter RCT
(likely funded by a programmatic or cooperative grant mechanism) to determine the efficacy of
LRFA, AcTIVE-CBT, or combined LRFA + AcTIVE-CBT, for Veterans with CLBP.