Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05792111
Status:
RECRUITING
Last Update Posted:
2023-03-31
First Post:
2022-10-18
Brief Title:
Caudal Epidural Steroid and Trigger Point Injection
Sponsor:
Abant Izzet Baysal University
Organization:
Abant Izzet Baysal University
Study Overview
Official Title:
Analgesic Effects of Trigger Point Injection Added to Caudal Epidural Steroid
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective randomized study will be conducted in Bolu Abant İzzet Baysal University Hospital Chronic low back and hip pain 72 patients aged between 18-70 years will be included in the study The primary output of our study was NRS scores The study of Manchikanti L et al control group NRS reduction 44 18 α margin of error 005 power 99 3 was taken as the basis for determining the sample size Using the G Power 3 calculator program 72 patients were identified to reduce their NRS scores by 25 With a 20 exclusion rate the total number of patients was calculated as 90
Detailed Description:
Demographic information of all patients included in the study name surname telephone number age gender educational status profession and marital status will be recorded The duration of the pain the onset of the pain the accompanying leg pain the activities that increase or decrease the pain the presence of neurological symptoms the analgesic agents used in the last week and the previous treatments will be noted Lumbar MRI findings and the level of pathology causing low back and hip pain will be recorded History family history comorbidities hypertension diabetes mellitus hyperlipidemia cardiac disease hypothyroidism and detailed physical examinations of the patients will be recorded Examinations of the patients before and 3 6 and 12 weeks after the injection will be performed and NRS scores at 3 and 6 weeks The procedures will be repeated for patients who are over 4 years old During the pre-procedural evaluation the patients will be informed about the study information about the Numeric Rating Score NRS Oswestry Disability Index ODI Short Form-36 SF-36 to be used for post-procedure analgesia and both verbal and written consents will be obtained The staff who will make the evaluation will not know which group the patients belong to and the study will be blinded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None