Ozone therapy versus surgery for lumbar disc herniation : A randomized double-blind controlled trial
Clavo, B. (Instituto Universitario de Investigaciones Biomédicas y Sanitarias (IUIBS). BioPharm Group. Universidad de Las Palmas de Gran Canaria)
Robaina, F. (Hospital Universitario de Gran Canaria Dr. Negrín)
Urrútia, Gerard (Institut d'Investigació Biomèdica Sant Pau)
Bisshopp, S. (Hospital Universitario de Gran Canaria Dr. Negrín)
Ramallo, Y. (Servicio de Evaluación y Planificación del Servicio Canario de la Salud (SESCS))
Szolna, A. (Hospital Universitario de Gran Canaria Dr. Negrín)
Caramés, M.A. (Hospital Universitario de Gran Canaria Dr. Negrín)
Fiuza, M.D. (Hospital Universitario de Gran Canaria Dr. Negrín)
Linertová, R. (Servicio de Evaluación y Planificación del Servicio Canario de la Salud (SESCS))

Date:	2021
Abstract:	Objectives: Surgery is the treatment of choice for symptomatic disc herniation after conservative management. Several studies have suggested the potential utility of intradiscal ozone infiltration in this pathology. The aim of this trial was to compare intradiscal ozone infiltration vs. oxygen infiltration vs. surgery. Design and interventions: This was a randomized, double-blinded, and controlled trial in patients on a waiting list for herniated disc surgery. There were three treatment groups: surgery; intradiscal ozone infiltration (plus foraminal infiltration of ozone, steroids, and anesthetic); intradiscal oxygen infiltration (plus foraminal infiltration of oxygen, steroids, and anesthetic). Main outcome measures: The requirements for surgery. Results: Five years after the treatment of the last recruited patient (median follow-up: 78 months), the requirement for further surgery was 20 % for patients in the ozone group and 60 % for patients in the oxygen group. 11 % of patients initially treated with surgery also required a second surgery. Compared to the surgery group, the ozone group showed: 1) significantly lower number of inpatient days: median 3 days (interquartile range: 3-3. 5 days) vs. 0 days (interquartile range: 0-1. 5 days), p = 0. 012; 2) significantly lower costs: median EUR 3702 (interquartile range: EUR 3283-7630) vs. EUR 364 (interquartile range: EUR 364-2536), p = 0. 029. Conclusions: Our truncated trial showed that intradiscal ozone infiltrations decreased the requirements for conventional surgery, resulting in decreased hospitalization durations and associated costs. These findings and their magnitude are of interest to patients and health services providers. Further validation is ongoing.
Grants:	Instituto de Salud Carlos III PI EC 07/90024 Instituto de Salud Carlos III PI 17/00120
Note:	Altres ajuts: Ministerio de Sanidad (Madrid); Ilustre Colegio de Médicos de Las Palmas (I19/18).
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Cost-effectiveness ; Disc herniation ; Microdiscectomy ; Ozone therapy ; Randomized controlled trial
Published in:	Complementary Therapies in Medicine, Vol. 59 (june 2021) , p. 102724, ISSN 1873-6963

DOI: 10.1016/j.ctim.2021.102724
PMID: 33964405

5 p, 2.3 MB

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Articles > Research articles
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