Clinical Effects of Ozone Therapy in Cervical Disc Hernia

The aim of the study is to evaluate the clinical effects of Ozone-oxygen therapy as therapeutic substance for nucleolysis application in the patients with cervical disc hernia who had chronic pain and weakness on the neck, shoulders and arms

Study Overview

• Status: Unknown
• Conditions: Pain, Neck
• Intervention / Treatment: Drug: Ozone

Detailed Description

This is a retrospective, single-center study that is going to be conducted from November 2013 to May 2016 on patients visiting the pain clinic of the hospital who were treated with Ozone-oxygen therapy for cervical discogenic or radicular pain.

Data collected from medical record forms and electronic medical record system of the hospital were used in the retrospective analysis of medical data with regard to age, gender, complications.

A resident who has not involved in the study interviewed each patient by telephone on the follow up to collect the related information.

• Study Type: Observational
• Enrollment (Anticipated): 43

Contacts and Locations

• Study Contact: Name: Havva Sayhan, Assis Prof; Phone Number: +905056621021; Email: hsayhan@gmail.com
• Study Contact Backup: Name: Serbülent Beyaz, AssocProf; Phone Number: +905322879490; Email: sgbeyaz@gmail.com

Study Locations

• Turkey
  • Sakarya, Turkey, 54100
    • Recruiting
    • Sakarya University Research and Training hospital
    • Contact: Havva Sayhan, Assis Prof; Phone Number: +905056621021; Email: hsayhan@gmail.com
    • Contact: Serbülent Beyaz, Assoc Prof; Phone Number: 6166 +90 264 8884051; Email: sgbeyaz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study was conducted from November 2013 to May 2016 on patients visiting the pain clinic who had cervical diskogenic or radicular pain that did not resolve after the use of conventional therapy.

Description

Inclusion Criteria:

• continuous radicular pain radiating to the upper limb, with a duration ≥8 weeks and an intensity >4/10 as rated by the patient on a visual analog scale (VAS)
• resistant to appropriate conservative treatment combining antiinflammatory drugs, and confirmed by imaging with CT or MRI of a herniated disc putting pressure on a nerve root consistent with the clinical pain.

Exclusion Criteria:

• history of surgery at the cervical spine, contraindication to percutaneous chemonucleolysis (coagulopathy or infection), imaging results that did not support the clinical results, the presence of a herniated disc excluded or calcified on imaging, possible interference with pain evaluation due to any medical condition or treatment, involvement of incomplete data collection

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ozone; Chemonucleolysis by ozone therapy Patients visiting the pain clinic of the hospital who had cervical discogenic or radicular pain that did not resolve after the use of conventional therapy. Written informed consent was obtained from all participants.	Drug: Ozone; Pain relief with chemonucleolysis by using ozone regard to age, sex, ASA score, and complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS) score for pain	Ozone therapy technique for pain relief assessed by Statistical Package for the Social Sciences (SPSS) v22.0 Statistical assessment of each patient was evaluated on time intervals before procedure, in the 1st month after procedure for Visual analogue scale (VAS) score for pain	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI) score	Assessment of degree of disability and estimating quality of life based on Oswestry Disability Index (ODI) score by SPSS v22.0 Statistical assessment of each patient was evaluated on time intervals before procedure, in the 3rd months after procedure for ODI score	3 months
ODI score	Assessment of degree of disability and estimating quality of life based on Oswestry Disability Index (ODI) score by SPSS v22.0 Statistical assessment of each patient was evaluated on time intervals before procedure, in the 1st month after procedure for ODI score	1 month

Collaborators and Investigators

• Sponsor: Sakarya University
• Investigators: Study Chair: Serbülent Beyaz, AssocProf, Sakarya University Research and Training hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: cervical; ozone therapy; percutaneous treatment; Oswestry Disability Index (ODI); Visual analog Scale (VAS); Neuropathic Pain Questionnaire (DN-4)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: sakarya Ozone

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No