Clinical Effects of Ozone Therapy in Cervical Disc Hernia

Pain, Neck Clinical Trial

Official title:

Clinical Effects of Ozone Therapy in Cervical Disc Hernia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03056911
• Other study ID #: sakarya Ozone
• Status: Recruiting
• Phase: N/A
• First received: February 15, 2017
• Last updated: February 16, 2017
• Start date: March 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: February 2017
• Source: Sakarya University
• Contact: Havva Sayhan, Assis Prof
• Phone: +905056621021
• Email: hsayhan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain
• Pain, Neck

Intervention

Drug:
• Ozone
Pain relief with chemonucleolysis by using ozone regard to age, sex, ASA score, and complications.

Locations

Country	Name	City	State
Turkey	Sakarya University Research and Training Hospital	Sakarya

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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