Ozone Therapy in Patients on Waiting List for Surgery Due to Disc Herniation: Prospective, Post-authorization Study
O3HDCIRUGIA
O3HDCIRUGIA
Sponsor study identifier
observational
70
1 country
1
Study Start
March 9, 2018
Actual (reported)Primary Completion
December 31, 2023
Actual (reported)Study Completion
March 31, 2026
Actual (reported)The main objective of this study is to estimate the cost-effectiveness of ozone therapy in patients on the waiting list for surgery due to disc herniation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 12, 2017
Actual (reported)September 14, 2017
Actual (reported)March 9, 2018
Actual (reported)December 31, 2023
Actual (reported)March 31, 2026
Actual (reported)Direct Hospital Cost for patients included on waiting list for surgery due to disc herniation.
Euros
24 months
Percentage of surgeries finally performed.
Percentage of surgeries performed after enrollment
24 months
Change from Baseline in sciatic pain at 12 months
Visual Analogic Scale (VAS)
12 months
Change from Baseline in sciatic pain at 24 months
Visual Analogic Scale (VAS)
24 months
Change from Baseline in sciatic pain at 6 months
6 months
Change from Baseline in lumbar pain at 6 months
6 months
Change from Baseline in lumbar pain at 12 months
12 months
Change from Baseline in lumbar pain at 24 months
24 months
Number of hospital stay days
24 months
Patients on waiting list for surgery (by discectomy/microdiscectomy) who reject ozone infiltration during waiting time. These patients will receive standard pain treatment until the planned surgery.
Patients on waiting list for surgery (by discectomy/microdiscectomy) who accept treatment by ozone infiltration during waiting time. These patients will be treated primarily by ozone therapy: Infiltration of intradiscal O3/O2 + foraminal infiltration of O3/O2 + corticoid + anesthetic. These patients will receive standard pain treatment until the planned surgery.
Adults with symptomatic lumbar herniated disc in whom conservative medical management has failed and: 1) in whom discectomy or microdiscectomy is indicated, 2) have been included in surgery waiting list by the Neurosurgery Department, 3) who meet criteria for potential benefit with ozone therapy and 4) who accept participating in the study by answering/filling in the specific study questionnaires (wether they accept or not the ozone therapy).
Dr. Negrin University Hospital
Las Palmas de Gran Canaria, Las Palmas, 35019, Spain
Magalhaes FN, Dotta L, Sasse A, Teixera MJ, Fonoff ET. Ozone therapy as a treatment for low back pain secondary to herniated disc: a systematic review and meta-analysis of randomized controlled trials. Pain Physician. 2012 Mar-Apr;15(2):E115-29.
Sherman J, Cauthen J, Schoenberg D, Burns M, Reaven NL, Griffith SL. Economic impact of improving outcomes of lumbar discectomy. Spine J. 2010 Feb;10(2):108-16. doi: 10.1016/j.spinee.2009.08.453. Epub 2009 Oct 12.
Bernardino Clavo, MD, PhD
Dr. Negrín University Hospital, Las Palmas, Spain
Pedro G. Serrano-Aguilar, MD, PhD
Servicio de Evaluación. Servicio Canario de Salud. Spain
Renata Linertová, MD, PhD
Fundación Canaria de Investigación Sanitaria (FUNCANIS)
Adam Szolna, MD, PhD
Dr. Negrín University Hospital, Las Palmas. Spain
70 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2017
First Posted
September 14, 2017
Study Start
March 9, 2018
Actual (reported)Assesment of Epidural Platelet-Rich Plasma (PRP) Injection During Uniportal Endoscopic Lumbar Disc Herniation Excision on Residual Neuropathies
Contact the study team to confirm eligibility.
Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. doi: 10.1097/brs.0b013e318182e390.
Hansson E, Hansson T. The cost-utility of lumbar disc herniation surgery. Eur Spine J. 2007 Mar;16(3):329-37. doi: 10.1007/s00586-006-0131-y. Epub 2006 May 9.
Luhmann D, Burkhardt-Hammer T, Borowski C, Raspe H. Minimally invasive surgical procedures for the treatment of lumbar disc herniation. GMS Health Technol Assess. 2005 Nov 15;1:Doc07.
Primary Completion
December 31, 2023
Actual (reported)Study Completion
March 31, 2026
Actual (reported)Last Updated
September 18, 2026
Record last verified: 2026-09
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