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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lumbar Herniated Disc

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery<br>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<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disc Herniation, Lumbar Herniated Disc, Ozone Therapy