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It has proved extremely difficult
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| Name | Class |
|---|---|
| Fondo de Investigacion Sanitaria | OTHER |
| Hospital NegrÃn | UNKNOWN |
| Hospital Son Llatzer | OTHER |
| Servicio de Salud de las Islas Baleares (Ib-Salut) |
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The purpose of this study is to assess the efficacy (vs. placebo) of ozone infiltration and its effectiveness in comparison with micro discectomy in the treatment of lumbar herniated disc with criteria for surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Discectomy/micro discectomy |
|
| 2 | Active Comparator | Intradiscal ozone infiltration |
|
| 3 | Active Comparator | Intradiscal oxygen infiltration (control arm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discectomy/ micro discectomy | Procedure | Standard discectomy or micro discectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of infiltration with corticoids+anesthetics+ozone in comparison with corticoids+anesthetics+oxygen (considered placebo for ozone) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness of both types of infiltration (used in primary outcome) in comparison with discectomy/micro discectomy | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco M Kovacs, MD, PhD | Kovacs Foundation, Palma de Mallorca, 07012, Spain | Study Chair |
| Bernardino Clavo, MD | Hospital NegrÃn, Las Palmas de Gran Canaria, 35010 Spain | Study Director |
| Francisco Robaina, MD | Hospital NegrÃn, Las Palmas de Gran Canaria 35010 Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital NegrÃn | Las Palmas de Gran Canaria | Canary Islands | 35010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12748111 | Background | Andreula CF, Simonetti L, De Santis F, Agati R, Ricci R, Leonardi M. Minimally invasive oxygen-ozone therapy for lumbar disk herniation. AJNR Am J Neuroradiol. 2003 May;24(5):996-1000. | |
| 15891150 | Background | Bonetti M, Fontana A, Cotticelli B, Volta GD, Guindani M, Leonardi M. Intraforaminal O(2)-O(3) versus periradicular steroidal infiltrations in lower back pain: randomized controlled study. AJNR Am J Neuroradiol. 2005 May;26(5):996-1000. |
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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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| ID | Term |
|---|---|
| D017586 | Diskectomy |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
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| UNKNOWN |
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| Ozone therapy |
| Drug |
Infiltration of intradiscal ozone: O3/O2 in a 27 micrograms/ml concentration + foraminal infiltration of O3/O2 + corticoid + anesthetic |
|
| Oxygen therapy | Drug | Intradiscal oxygen therapy: O3/O2 at a concentration of 0 micrograms/ml (only oxygen) + foraminal infiltration of O2 + corticoid + anesthetic |
|
| 8324077 | Background | Bocci V, Luzzi E, Corradeschi F, Paulesu L, Di Stefano A. Studies on the biological effects of ozone: 3. An attempt to define conditions for optimal induction of cytokines. Lymphokine Cytokine Res. 1993 Apr;12(2):121-6. |
| 10488513 | Background | Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine (Phila Pa 1976). 1999 Sep 1;24(17):1820-32. doi: 10.1097/00007632-199909010-00012. |
| 40648907 | Derived | Bisshopp S, Linertova R, Carames MA, Szolna A, Jorge IJ, Navarro M, Melchiorsen B, Rodriguez-Diaz B, Gonzalez-Martin JM, Clavo B. Pain Relief, Disability, and Hospital Costs After Intradiscal Ozone Treatment or Microdiscectomy for Lumbar Disc Herniation: A 24-Month Real-World Prospective Study. J Clin Med. 2025 Jun 26;14(13):4534. doi: 10.3390/jcm14134534. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |