|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03056911 |
|
Date of registration:
|
15/02/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Effects of Ozone Therapy in Cervical Disc Hernia
|
|
Scientific title:
|
Clinical Effects of Ozone Therapy in Cervical Disc Hernia |
|
Date of first enrolment:
|
March 1, 2017 |
|
Target sample size:
|
43 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03056911 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Turkey
| | | | | | | |
|
Contacts
|
|
Name:
|
Serbülent Beyaz, AssocProf |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Sakarya University Research and Training Hospital |
|
|
Name:
|
Havva Sayhan, Assis Prof |
|
Address:
|
|
|
Telephone:
|
+905056621021 |
|
Email:
|
hsayhan@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Havva Sayhan, Assis Prof |
|
Address:
|
|
|
Telephone:
|
+905056621021 |
|
Email:
|
hsayhan@gmail.com |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pain, Neck
|
|
Intervention(s)
|
|
Drug: Ozone
|
|
Primary Outcome(s)
|
|
Visual analogue scale (VAS) score for pain
[Time Frame: 1 month]
|
|
Secondary Outcome(s)
|
|
Oswestry Disability Index (ODI) score
[Time Frame: 3 months]
|
|
ODI score
[Time Frame: 1 month]
|
|
Secondary ID(s)
|
|
sakarya Ozone
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|