Clinical trial NCT03056911: Clinical Effects of Ozone Therapy in Cervical Disc Hernia
Official title: Clinical Effects of Ozone Therapy in Cervical Disc Hernia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Neck
Keywords: ozone therapy
percutaneous treatment
Oswestry Disability Index (ODI)
Visual analog Scale (VAS)
Neuropathic Pain Questionnaire (DN-4)
cervical
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale (VAS) score for pain
timeFrame: 1 month
Secondary outcomes:
measure: Oswestry Disability Index (ODI) score
timeFrame: 3 months
measure: ODI score
timeFrame: 1 month
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Research and Training Hospital
Study officials:
affiliation: Sakarya University Research and Training Hospital
name: Serbülent Beyaz, AssocProf
role: STUDY_CHAIR
References:
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.