Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT03282695
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03282695
Study Brief:
Protocol Section:
NCT03282695