Intervention Clinical Trial
— D228Official title:
Cervical Epidural Versus Cevical Facet Injection for Patients With Chronic Cervical Pain
Verified date | October 2023 |
Source | Fayoum University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
After approval of the institutional review board and the Ethics Committee of Al Fayoum University number (D228) , and written informed consent from all patientá¹£ Pilot study will be done to confirm this sample size .The patients are classified in two groups group P for cervical epidural and group F for facet injection To compare effectivness of cervical epidural versus cervical facet injection under fluroscopic guidance in patients sufferring from chronic neck pain.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 20, 2022 |
Est. primary completion date | December 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients age between 20 - 70 years old. - ASA I and II - Cervical pain at least 3 months before procedure - Patients have failed pharmacological treatment. Exclusion Criteria: - Systemic infection - Skin infection - Bleeding tendency and coagulopathy - Pregnancy - Neurological disorders - Any deformaties that disfacilate the procedure |
Country | Name | City | State |
---|---|---|---|
Egypt | Atef Mohamed mahmoud | Fayoum |
Lead Sponsor | Collaborator |
---|---|
Fayoum University Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Total opoid and non steroidal consumption preintervention | Pre intervention total dose of opoid and an non steroid consumption | measured once 1 day preintervention | |
Other | Total opoid and non steroidal consumption post intervention | Total dose intake of opoid and non steroid consumption post intervention | measured (1 month,3 month,6 month,12 month)"post intervention | |
Other | VAS Score | Graded frome 0 no pain to 10 maximum pain | 0 hour, 2 hours, 4 hours, 6hours, 12 hours, 18 hours, 24 hours post operative | |
Other | Post operative Nausea & vomiting score | From grade 0 no nausea or vomiting to grade 4 sever vomitting | 0 hour,2 hours,4 hours,6 hours,12 hours,18 hours,24 hours post operative | |
Primary | Neck pain disability index preintervention | The NDI has become a standard instrument for measuring self-rated disability due to neck pain and is used by clinicians and researchers alike.
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. Occasionally, a respondent will not complete one question or another. The average of all other items is then added to the completed items. The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability 5 - 14 = mild 15 - 24 = moderate 25 - 34 = severe above 34 = complete. |
measured once within 1 day pre intervention | |
Primary | Change in Neck pain disability index post intervention | The NDI has become a standard instrument for measuring self-rated disability due to neck pain and is used by clinicians and researchers alike.
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. Occasionally, a respondent will not complete one question or another. The average of all other items is then added to the completed items. The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability 5 - 14 = mild 15 - 24 = moderate 25 - 34 = severe above 34 = complete. |
1 month, 3 month, 6 month,12 month |
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