Clinical Effects of Ozone Therapy in Cervical Disc Hernia

NCT ID: NCT03056911

Last Updated: 2017-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-01-01

Brief Summary

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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

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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.

Conditions

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Pain, Neck

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Ozone

Intervention Type DRUG

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

Interventions

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Ozone

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sakarya University

OTHER

Sponsor Role lead

Responsible Party

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Havva Sayhan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serbülent Beyaz, AssocProf

Role: STUDY_CHAIR

Sakarya University Research and Training Hospital

Locations

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Sakarya University Research and Training Hospital

Sakarya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Havva Sayhan, Assis Prof

Role: CONTACT

+905056621021

Serbülent Beyaz, AssocProf

Role: CONTACT

+905322879490

Facility Contacts

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Havva Sayhan, Assis Prof

Role: primary

+905056621021

Serbülent Beyaz, Assoc Prof

Role: backup

+90 264 8884051 ext. 6166

References

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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.

Reference Type RESULT
PMID: 22430658 (View on PubMed)

Other Identifiers

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sakarya Ozone

Identifier Type: -

Identifier Source: org_study_id

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