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Clinical Effects of Ozone Therapy in Cervical Disc Hernia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056911
Recruitment Status : Unknown
Verified February 2017 by Havva Sayhan, Sakarya University.
Recruitment status was:  Recruiting
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Havva Sayhan, Sakarya University

Study Description
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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

Condition or disease Intervention/treatment
Pain, Neck 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 Design
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Study Type : Observational
Estimated Enrollment : 43 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Clinical Effects of Ozone Therapy in Cervical Disc Hernia
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia Ozone

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Visual analogue scale (VAS) score for pain [ Time Frame: 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 :
  1. Oswestry Disability Index (ODI) score [ Time Frame: 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

  2. ODI score [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056911


Contacts
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Contact: Havva Sayhan, Assis Prof +905056621021 hsayhan@gmail.com
Contact: Serbülent Beyaz, AssocProf +905322879490 sgbeyaz@gmail.com

Locations
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Turkey
Sakarya University Research and Training Hospital Recruiting
Sakarya, Turkey, 54100
Contact: Havva Sayhan, Assis Prof    +905056621021    hsayhan@gmail.com   
Contact: Serbülent Beyaz, Assoc Prof    +90 264 8884051 ext 6166    sgbeyaz@gmail.com   
Sponsors and Collaborators
Sakarya University
Investigators
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Study Chair: Serbülent Beyaz, AssocProf Sakarya University Research and Training Hospital
More Information
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Publications of Results:

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Responsible Party: Havva Sayhan, Assistant Professor, Sakarya University
ClinicalTrials.gov Identifier: NCT03056911    
Other Study ID Numbers: sakarya Ozone
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Havva Sayhan, Sakarya University:
ozone therapy
percutaneous treatment
Oswestry Disability Index (ODI)
 Visual analog Scale (VAS)
Neuropathic Pain Questionnaire (DN-4)
cervical
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations