{"doi":"10.1101/2023.06.02.23290392","title":"Combining Procedural and Behavioral Treatments for Chronic Low Back Pain: A Pilot Feasibility Randomized Controlled Trial","abstract":"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 2×2 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 AcTIVECBT 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.","journal":"medRxiv","year":2023,"id":399704,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9567,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1175774,"name":"Isuta Nishio","orcid":"0009-0001-7264-6682","position":1,"is_corresponding":false},{"id":721648,"name":"Rhonda M. Williams","orcid":"0000-0002-9793-3653","position":2,"is_corresponding":false},{"id":372165,"name":"Janna Friedly","orcid":"0000-0002-7483-7888","position":3,"is_corresponding":false},{"id":1176127,"name":"Bosco Soares","orcid":null,"position":4,"is_corresponding":false},{"id":795560,"name":"Derek Anderson","orcid":null,"position":5,"is_corresponding":false},{"id":1176128,"name":"Jennifer K. Bambara","orcid":null,"position":6,"is_corresponding":false},{"id":1175775,"name":"Timothy Dawson","orcid":"0000-0001-8017-5836","position":7,"is_corresponding":false},{"id":362027,"name":"Amy P. Hsu","orcid":"0000-0001-6841-2122","position":8,"is_corresponding":false},{"id":1176129,"name":"Peggy Y. Kim","orcid":null,"position":9,"is_corresponding":false},{"id":1176130,"name":"Daniel Krashin","orcid":null,"position":10,"is_corresponding":false},{"id":936961,"name":"Larissa Del Piero","orcid":"0000-0002-4407-5472","position":11,"is_corresponding":false},{"id":951907,"name":"Anna Korpak","orcid":"0000-0002-8771-5468","position":12,"is_corresponding":false},{"id":951908,"name":"Andrew Timmons","orcid":"0000-0003-4013-716X","position":13,"is_corresponding":false},{"id":466990,"name":"Pradeep Suri","orcid":"0000-0002-9449-4165","position":14,"is_corresponding":false},{"id":1175773,"name":"Adrienne D. Tanus","orcid":"0009-0000-5358-8328","position":0,"is_corresponding":true}],"reference_count":34,"raw_metadata":null,"created_at":"2026-07-19T01:19:56.084411Z","pmid":"37333215","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}