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.
Study Type
OBSERVATIONAL
Enrollment
70
Dr. Negrin University Hospital
Las Palmas de Gran Canaria, Las Palmas, Spain
Direct Hospital Cost for patients included on waiting list for surgery due to disc herniation.
Euros
Time frame: 24 months
Percentage of surgeries finally performed.
Percentage of surgeries performed after enrollment
Time frame: 24 months
Change from Baseline in sciatic pain at 12 months
Visual Analogic Scale (VAS)
Time frame: 12 months
Change from Baseline in sciatic pain at 24 months
Visual Analogic Scale (VAS)
Time frame: 24 months
Change from Baseline in sciatic pain at 6 months
Visual Analogic Scale (VAS)
Time frame: 6 months
Change from Baseline in lumbar pain at 6 months
Visual Analogic Scale (VAS)
Time frame: 6 months
Change from Baseline in lumbar pain at 12 months
Visual Analogic Scale (VAS)
Time frame: 12 months
Change from Baseline in lumbar pain at 24 months
Visual Analogic Scale (VAS)
Time frame: 24 months
Number of hospital stay days
Number of hospital stay days
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Time frame: 24 months
Restriction of everyday activities
Spanish version of Roland-Morris questionnaire
Time frame: 24 months
Quality of life by 12-Item Short Form Survey (SF-12)
SF-12 questionnaire
Time frame: 24 months
Quality of life by the five-level version of the EuroQol five-dimensional (EQ-5D-5L) questionnaire
EQ-5D-5L questionnaire
Time frame: 24 months
Loss of labour productivity
Off work days (if applicable)
Time frame: 24 months
Time to resume normal activity
Days
Time frame: 24 months
Direct sanitary and non-sanitary costs incurred out of hospital.
Euros
Time frame: 24 months
Adverse effects
Number of serious adverse effects
Time frame: 24 months
Time from inclusion on waiting list for surgery to completion of the procedure.
Days
Time frame: 24 months