Ozone Therapy in Patients on Waiting List for Surgery Due to Disc Herniation: Prospective, Post-authorization Study (O3HDCIRUGIA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lumbar Herniated Disc

Detailed Description

A cohort study (patients on the waiting list for surgery due to herniated disc) will be carried out, to which the treatment with ozone will be offered, without giving up the planned surgical intervention.

The main objective of this prospective, post-authorization follow-up study is to estimate the cost-effectiveness of ozone therapy (compared to standard care) in patients with disc herniation waiting for surgery (by microdiscectomy). Besides utilities of patients with disc herniation on a waiting list for surgery will be estimated, social/economic burden of disc herniation will be quantified and a decision aid will be developed and applied.

The main outcome measures are "Direct hospital cost", "Percentage of executed surgeries" and "Change in sciatic pain". In addition, data on health-related quality of life and resource utilization will be collected which will permit to estimate the incremental cost-effectiveness ratio (ICER), comparing incremental costs and quality adjusted life years (QALY).

The variables will be collected at the beginning, on the day of treatment and at 1, 3, 6, 12 and 24 months. The enrollment period will be 24 months. The follow-up period will be 24 months.

The results of the study will allow a better understanding of the value of ozone therapy in the management of patients on the waiting list for herniated disc surgery. In addition, it will contribute to the development of a more patient-centered health system.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• Spain
  • Las Palmas
    • Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
      • Dr. Negrin University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

• Diagnosed with a herniated and not calcified lumbar disc that presents as: not migrated protrusion and/or extrusion.
• Evaluated and diagnosed by the Neurosurgery Department, having been chosen as an appropriate candidate for surgery consisting in discectomy or microdiscectomy, after meeting the following two criteria: 1) Sciatic pain, with a visual analogue scale (VAS) intensity ≥ 5, despite 6 weeks of conservative management, wether it exists lumbar pain or not and 2) Radiating pain that matches the MRI image showing one or more herniated discs (not to be considered those patients with two herniated discs and symptoms attributable to only one of the herniated discs).
• Included in the surgery waiting list for a discectomy or microdiscectomy.
• Patients who have signed and dated the study 's specific informed consent.

Exclusion Criteria:

• Patients who do not meet all the inclusion criteria.
• Calcified and/or migrated herniated disc, and/or with a severe neurological deficits (cauda equine syndrome).
• Herniated disc with surgical indication of laminectomy and/or arthrodesis (massive extrusion, sign of instability or other conditions under the neurosurgeon judgment).
• Relevant clinical paresis that does not improve despite 6 weeks of full conservative management (patients with severe pain and mild paresis that only shows up in the physical exam are not to be excluded, but those who present with paresis as the main symptom -"clinically relevant"- must be).
• Simultaneous symptomatic cervical or dorsal herniated discs.
• Previous lumbar spine surgery.
• Concomitant spine conditions that may be causing symptoms or have indication for surgery (such as fractures or tumors).
• Known allergy to ozone.
• Those who are uncapable to fill in the scales used to measure variables in the study, like the visual analogue scale (VAS), Roland-Morris and SF-12 questionnaires.
• Those who are unable or do not wish to fulfill the study 's protocol (answer questions to collect the data).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Surgery; 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.
Ozone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in sciatic pain at 6 months	Visual Analogic Scale (VAS)	6 months
Change from Baseline in lumbar pain at 6 months	Visual Analogic Scale (VAS)	6 months
Change from Baseline in lumbar pain at 12 months	Visual Analogic Scale (VAS)	12 months
Change from Baseline in lumbar pain at 24 months	Visual Analogic Scale (VAS)	24 months
Number of hospital stay days	Number of hospital stay days	24 months
Restriction of everyday activities	Spanish version of Roland-Morris questionnaire	24 months
Quality of life by 12-Item Short Form Survey (SF-12)	SF-12 questionnaire	24 months
Quality of life by the five-level version of the EuroQol five-dimensional (EQ-5D-5L) questionnaire	EQ-5D-5L questionnaire	24 months
Loss of labour productivity	Off work days (if applicable)	24 months
Time to resume normal activity	Days	24 months
Direct sanitary and non-sanitary costs incurred out of hospital.	Euros	24 months
Adverse effects	Number of serious adverse effects	24 months
Time from inclusion on waiting list for surgery to completion of the procedure.	Days	24 months

Collaborators and Investigators

• Sponsor: Bernardino Clavo, MD, PhD
• Collaborators: Servicio Canario de Salud; Instituto de Salud Carlos III; Red de Investigación en Servicios de Salud en Enfermedades Crónicas; Colegio Oficial de Médicos de Las Palmas
• Investigators: Study Chair: Bernardino Clavo, MD, PhD, Dr. Negrín University Hospital, Las Palmas, Spain; Study Director: Pedro G. Serrano-Aguilar, MD, PhD, Servicio de Evaluación. Servicio Canario de Salud. Spain; Principal Investigator: Renata Linertová, MD, PhD, Fundación Canaria de Investigación Sanitaria (FUNCANIS); Principal Investigator: Adam Szolna, MD, PhD, Dr. Negrín University Hospital, Las Palmas. Spain

Publications and helpful links

General Publications

• 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. Erratum In: Spine J. 2010 May;10(5):A8.
• 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.

Helpful Links

• Report (June 2016) about Ozone therapy in disc herniation, from the Health Technology Assessment (HTA) Unit, Canary Health Service, Spain

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Disc Herniation; Lumbar Herniated Disc; Ozone Therapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: BCV-OZO-2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No