title: Twelve-Month Follow-up of a Randomized Clinical Trial Comparing Intradiscal Biacuplasty to Conventional Medical Management for Discogenic Lumbar Back Pain.
abstract: This report conveys 12-month outcomes of subjects treated with intradiscal biacuplasty (IDB) and conservative medical management (CMM) for chronic low back pain of discogenic origin, and results for subjects who elected to receive IDB + CMM 6 months after CMM-alone.
  
  
  
  Sixty-three subjects were originally randomized to the IDB + CMM group (N = 29) or CMM-alone (N = 34). Six months following continuous CMM-alone treatment, participants in this study group were permitted to "cross-over" to IDB + CMM (N = 25), and followed for an additional 6 months. The original IDB + CMM study subjects were followed for a total of 12 months (N = 22).
  
  
  
  Pain reduction at 12 months was statistically significant and clinically meaningful in the original IDB + CMM group compared to baseline. Functional and disability outcomes were also improved statistically and clinically. Fifty-five percent of the IDB + CMM patients responded to treatment with a mean VAS reduction of 2.2 points at 12 months. Furthermore, 50% and 64% of subjects reported clinically significant improvements in SF36-PF and in ODI, respectively. There was a 1.7-point reduction (improvement) on a 7-point PGIC scale, and a 0.13-point increase (improvement) in the EQ-5D Health Index. Fifty-percent of cross-over subjects responded to IDB + CMM intervention. Mean outcome scores for cross-over subjects were similar to those of the originally-treated subjects, and functional and disability endpoints were improved statistically and clinically compared to respective baseline values.
  
  
  
  The study demonstrated long-term clinical effectiveness of IDB + CMM for treating chronic lumbar discogenic pain. Furthermore, the cross-over study subjects experienced similar improvements in pain, function, disability, and satisfaction.
authors: George Washington University Medical Center, Washington, District of Columbia, USA.|International Spine, Pain, and Performance Center, Washington, District of Columbia, USA.
authors: Mehul J
authors: MJ
authors: Desai
authors: Center for Clinical Research, Winston-Salem, North Carolina, USA.
authors: Leonardo
authors: L
authors: Kapural
authors: PainCare, Linwood, New Jersey, USA.
authors: Jeffrey D
authors: JD
authors: Petersohn
authors: Millennium Pain Center, Bloomington, Illinois, USA.
authors: Ricardo
authors: R
authors: Vallejo
authors: JPS Orthopedic and Sports Medicine, Arlington, Texas, USA.
authors: Robert
authors: R
authors: Menzies
authors: Compass Research, Orlando, Florida, USA.
authors: Michael
authors: M
authors: Creamer
authors: Department of Anesthesia and Pain Medicine, University Health Network, Toronto, Canada.
authors: Michael
authors: M
authors: Gofeld
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017115:Catheter Ablation / Q000379:methods*; D059350:Chronic Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D055959:Intervertebral Disc Degeneration / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D008137:Longitudinal Studies; D017116:Low Back Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D020127:Recovery of Function; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
keywords: Biacuplasty; Chronic Pain; Discogenic Pain; Intervertebral Disc; Radiofrequency; Randomized Clinical Trial