Status:
ACTIVE_NOT_RECRUITING
Ozone Therapy in Patients on Waiting List for Surgery Due to Disc Herniation: Prospective, Post-authorization Study
Lead Sponsor:
Bernardino Clavo, MD, PhD
Collaborating Sponsors:
Servicio Canario de Salud
Red de Investigación en Servicios de Salud en Enfermedades Crónicas
Conditions:
Lumbar Herniated Disc
Eligibility:
All Genders
18-75 years
Brief Summary
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
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 intervent...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03282695
Start Date
March 9 2018
End Date
March 31 2026
Last Update
March 4 2025
Active Locations (1)
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1
Dr. Negrin University Hospital
Las Palmas de Gran Canaria, Las Palmas, Spain, 35019