Combining Procedural and Behavioral Treatments for Chronic Low Back Pain: A Pilot Feasibility Randomized Controlled Trial

Individual treatments for chronic low back pain (CLBP) have small magnitude effects. Combining different types of treatments may produce larger effects. This study used a 2x2 factorial randomized controlled trial (RCT) design to combine procedural and behavioral treatments for CLBP. The study aims were to: (1) assess feasibility of conducting a factorial RCT of these treatments; and (2) estimate individual and combined treatment effects of (a) lumbar radiofrequency ablation (LRFA) of the dorsal ramus medial branch nerves (vs. a simulated LRFA control procedure) and (b) Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program for CLBP (AcTIVE-CBT) (vs. an educational control treatment) on back-related disability at 3 months post-randomization. Participants (n=13) were randomized in a 1:1:1:1 ratio. Feasibility goals included an enrollment proportion ≥30%, a randomization proportion ≥80%, and a ≥80% proportion of randomized participants completing the 3-month Roland-Morris Disability Questionnaire (RMDQ) primary outcome endpoint. An intent-to-treat analysis was used. The enrollment proportion was 62%, the randomization proportion was 81%, and all randomized participants completed the primary outcome. Though not statistically significant, there was a beneficial, moderate-magnitude effect of LRFA vs. control on 3-month RMDQ (-3.25 RMDQ points; 95% CI: -10.18, 3.67). There was a significant, beneficial, large-magnitude effect of AcTIVE-CBT vs. control (-6.29, 95% CI: -10.97, -1.60). Though not statistically significant, there was a beneficial, large effect of LRFA+AcTIVE-CBT vs. control (-8.37; 95% CI: -21.47, 4.74). We conclude that it is feasible to conduct an RCT combining procedural and behavioral treatments for CLBP. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT03520387 ### Funding Statement This research was supported by the Department of Veterans Affairs (VA), Veterans Health Administration, Office of Research and Development (ORD), Rehabilitation Research and Development (RR&D) Service under award number I21RX002891. Ms. Tanus, Dr. Nishio, Dr. Williams, Dr. Anderson, Dr. Bambara, Dr. Dawson, Dr. Hsu, Dr. Kim, Dr. Krashin, Dr. Korpak, Mr. Timmons, and Dr. Suri are employees of the VA Puget Sound Health Care System in Seattle, Washington. Drs. Soares and Del Piero were employees at VAPSHCS when this study was conducted. Methodologic consultation was provided by the University of Washington Clinical Learning, Evidence And Research (CLEAR) Center for Musculoskeletal Research Methodologic Core; the CLEAR Center is a Core Center for Clinical Research (CCCR) funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health (NIH) under Award Number P30AR072572. The content is solely the responsibility of the authors and does not reflect the views or opinions of the VA or NIH. The authors have no conflicts of interest. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. 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