Clinical Effects of Ozone Therapy in Cervical Disc Hernia

• Conditions: Pain, Neck
• Interventions: Drug: Ozone

• Registration Number: NCT03056911
• Lead Sponsor: Sakarya University

Brief Summary

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

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 Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-16
• Last Update Submitted: 2017-02-16
• Study First Posted: 2017-02-17
• Last Update Posted: 2017-02-17
• Study Start: 2017-03-01
• Primary Completion: 2018-01-01
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ozone	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.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) score for pain	1 month	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

Secondary Outcome Measures

Name	Time	Method
ODI score	1 month	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
Oswestry Disability Index (ODI) score	3 months	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

Trial Locations

Locations (1)

Sakarya University Research and Training Hospital; 🇹🇷 Sakarya, Turkey