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| Name | Class |
|---|---|
| Servicio Canario de Salud | OTHER |
| Red de Investigación en Servicios de Salud en Enfermedades Crónicas | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Bernardino Clavo, MD, PhD | Dr. Negrín University Hospital, Las Palmas, Spain | Study Chair |
| Pedro G. Serrano-Aguilar, MD, PhD | Servicio de Evaluación. Servicio Canario de Salud. Spain | Study Director |
| Renata Linertová, MD, PhD | Fundación Canaria de Investigación Sanitaria (FUNCANIS) | Principal Investigator |
| Adam Szolna, MD, PhD | Dr. Negrín University Hospital, Las Palmas. Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Negrin University Hospital | Las Palmas de Gran Canaria | Las Palmas | 35019 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22430658 | Background | 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. | |
| 19819761 | Background | 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. |
| Label | URL |
|---|---|
| Report (June 2016) about Ozone therapy in disc herniation, from the Health Technology Assessment (HTA) Unit, Canary Health Service, Spain | View source |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| Colegio Oficial de Médicos de Las Palmas |
| UNKNOWN |
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| 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 |
| 18777603 | Background | 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. |
| 16683121 | Result | 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. |
| 21289928 | Result | 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |