NCT03056911

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

February 15, 2017

Last Update Submit

February 16, 2017

Conditions

Pain, Neck

Keywords

ozone therapypercutaneous treatmentOswestry Disability Index (ODI)Visual analog Scale (VAS)Neuropathic Pain Questionnaire (DN-4)cervical

Outcome Measures

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

    1 month

Secondary Outcomes (2)

  • Oswestry Disability Index (ODI) score

    3 months

  • ODI score

    1 month

Study Arms (1)

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

OzoneDRUG

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

ozone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Research and Training Hospital

Sakarya, 54100, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 22430658RESULT

MeSH Terms

Conditions

Neck Pain

Interventions

Ozone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OxygenGasesInorganic Chemicals

Study Officials

  • Serbülent Beyaz, AssocProf

    Sakarya University Research and Training Hospital

    STUDY CHAIR

Central Study Contacts

Havva Sayhan, Assis Prof

CONTACT

+905056621021hsayhan@gmail.com

Serbülent Beyaz, AssocProf

CONTACT

+905322879490sgbeyaz@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 17, 2017

Study Start

March 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

TU(1)