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

Lumbar Herniated Disc Clinical Trial

— O3HDCIRUGIA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03282695
• Other study ID #: BCV-OZO-2016-01
• Status: Active, not recruiting
• Start date: March 9, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Dr. Negrin University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Herniated Disc

Locations

Country	Name	City	State
Spain	Dr. Negrin University Hospital	Las Palmas De Gran Canaria	Las Palmas

Sponsors (5)

Lead Sponsor	Collaborator
Bernardino Clavo, MD, PhD	Colegio Oficial de Médicos de Las Palmas, Instituto de Salud Carlos III, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Servicio Canario de Salud

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Spine J. 2010 May;10(5):A8. — View Citation

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. — View Citation

Outcome

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

External Links

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