- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03891680
Intra Articular Botox Injection in Treatment of Osteoarthritis (Osteoarthritis)
December 25, 2022 updated by: Manal Hassanien, Assiut University
Comparison Between Intraarticular Botox Injection Versus Genicular Pulsed Radio Frequency in Treatment of Patients With Osteoarthritis
Compared the short and long term effects sonography guided of intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Compared the short and long term effects of sonography guided intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Manal Hassanien
- Phone Number: 01062679200
- Email: manal_hassanien@yahoo.com
Study Contact Backup
- Name: Abdelraheem M Alawamy
- Email: manal_hassanien@yahoo.com
Study Locations
-
-
-
Assiut, Egypt
- Manal Hassanien
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- osteoarthritis
Exclusion Criteria:
- coagulopathy Organ failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Botox injection
|
Intra articular Botox injection
|
Active Comparator: Genicular Radio frequency
|
Genicular nerves radiofrequancy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain visual analog scale
Time Frame: 6 months
|
0-10 Visual analog scale( less than 3 no pain 3-5 in pain, more than 5 sever pain
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Abdallah Allam, Physical medicine Tanta university
- Study Chair: Rasha Gaber, Biochemistry Tanta university
- Study Chair: Ke Vin, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2019
Primary Completion (Actual)
March 30, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
March 23, 2019
First Submitted That Met QC Criteria
March 25, 2019
First Posted (Actual)
March 27, 2019
Study Record Updates
Last Update Posted (Estimate)
December 29, 2022
Last Update Submitted That Met QC Criteria
December 25, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Botox in osteoarthritis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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