CClinicalTrials.gg
Status unknownNCT03056911Updated Feb 17, 2017

Clinical Effects of Ozone Therapy in Cervical Disc Hernia

An observational study in Pain, Neck, sponsored by Sakarya University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-02-17.

Sponsored by Sakarya University · Observational

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
43
Ages
18 Years to 70 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Pain, Neck

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Keywords

  • ozone therapy
  • percutaneous treatment
  • Oswestry Disability Index (ODI)
  • Visual analog Scale (VAS)
  • Neuropathic Pain Questionnaire (DN-4)
  • cervical
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In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.

This study's planned enrollment of 43 is below the median of 90 across 213 observational studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Sakarya University is the lead sponsor of 178 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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.

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

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
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
43 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DrugOzone

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 month

Secondary outcomes

  1. 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

    Time frame: 3 months

  2. 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

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Sakarya University Research and Training Hospital
    Sakarya, 54100, Turkey
    Recruiting
08

References and documents

Publications

  • 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. PubMed 22430658 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03056911
Lead sponsor
Sakarya University
Responsible party
Havva Sayhan (Assistant Professor, Sakarya University) — Principal investigator
First posted
Feb 17, 2017
Start date
Mar 1, 2017 (estimated)
Primary completion
Jan 1, 2018 (estimated)
Completion
Jan 1, 2019 (estimated)
Last update
Feb 17, 2017

Study contacts

Havva Sayhan, Assis Prof
Contact
hsayhan@gmail.com
+905056621021
Serbülent Beyaz, AssocProf
Contact
sgbeyaz@gmail.com
+905322879490
Serbülent Beyaz, AssocProf
study chair · Sakarya University Research and Training Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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