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

NCT03282695 | Active Not Recruiting DMC

• 1 other identifier: BCV-OZO-2016-01
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Herniated Disc

Keywords

Disc Herniation; Lumbar Herniated Disc; Ozone Therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Change from Baseline in sciatic pain at 6 months

  6 months

• Change from Baseline in lumbar pain at 6 months

  6 months

• Change from Baseline in lumbar pain at 12 months

  12 months

• Change from Baseline in lumbar pain at 24 months

  24 months

• Number of hospital stay days

  24 months

Study Arms (2)

Surgery

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

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with symptomatic lumbar herniated disc in whom conservative medical management has failed and: 1) in whom discectomy or microdiscectomy is indicated, 2) have been included in surgery waiting list by the Neurosurgery Department, 3) who meet criteria for potential benefit with ozone therapy and 4) who accept participating in the study by answering/filling in the specific study questionnaires (wether they accept or not the ozone therapy).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bernardino Clavo, MD, PhD: lead
• Servicio Canario de Salud: collaborator
• Red de Investigación en Servicios de Salud en Enfermedades Crónicas: collaborator
• Instituto de Salud Carlos III: collaborator
• Colegio Oficial de Médicos de Las Palmas: collaborator

Study Sites (1)

Dr. Negrin University Hospital

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

Location

Related Publications (5)

• Hansson E, Hansson T. The cost-utility of lumbar disc herniation surgery. Eur Spine J. 2007 Mar;16(3):329-37. doi: 10.1007/s00586-006-0131-y. Epub 2006 May 9.

  PMID: 16683121 BACKGROUND

• Luhmann D, Burkhardt-Hammer T, Borowski C, Raspe H. Minimally invasive surgical procedures for the treatment of lumbar disc herniation. GMS Health Technol Assess. 2005 Nov 15;1:Doc07.

  PMID: 21289928 BACKGROUND

• Magalhaes FN, Dotta L, Sasse A, Teixera MJ, Fonoff ET. Ozone therapy as a treatment for low back pain secondary to herniated disc: a systematic review and meta-analysis of randomized controlled trials. Pain Physician. 2012 Mar-Apr;15(2):E115-29.

  PMID: 22430658 BACKGROUND

• Sherman J, Cauthen J, Schoenberg D, Burns M, Reaven NL, Griffith SL. Economic impact of improving outcomes of lumbar discectomy. Spine J. 2010 Feb;10(2):108-16. doi: 10.1016/j.spinee.2009.08.453. Epub 2009 Oct 12.

  PMID: 19819761 BACKGROUND

• Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. doi: 10.1097/brs.0b013e318182e390.

  PMID: 18777603 BACKGROUND

Related Links

• Report (June 2016) about Ozone therapy in disc herniation, from the Health Technology Assessment (HTA) Unit, Canary Health Service, Spain

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernardino Clavo, MD, PhD

  Dr. Negrín University Hospital, Las Palmas, Spain

  STUDY CHAIR

• Pedro G. Serrano-Aguilar, MD, PhD

  Servicio de Evaluación. Servicio Canario de Salud. Spain

  STUDY DIRECTOR

• Renata Linertová, MD, PhD

  Fundación Canaria de Investigación Sanitaria (FUNCANIS)

  PRINCIPAL INVESTIGATOR

• Adam Szolna, MD, PhD

  Dr. Negrín University Hospital, Las Palmas. Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD. PhD

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 14, 2017
• Study Start: March 9, 2018
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)