Back to resultsIntra Articular Botox Injection in Treatment of Osteoarthritis (Osteoarthritis)
Primary Purpose
Osteoarthritis Knees Both
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Botox Injectable Product
Radiofrequancy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Knees Both
Eligibility Criteria
Inclusion Criteria:
- osteoarthritis
Exclusion Criteria:
- coagulopathy Organ failure
Sites / Locations
- Manal Hassanien
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Botox injection
Genicular Radio frequency
Arm Description
Outcomes
Primary Outcome Measures
Pain visual analog scale
0-10 Visual analog scale( less than 3 no pain 3-5 in pain, more than 5 sever pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03891680
Brief Title
Intra Articular Botox Injection in Treatment of Osteoarthritis
Acronym
Osteoarthritis
Official Title
Comparison Between Intraarticular Botox Injection Versus Genicular Pulsed Radio Frequency in Treatment of Patients With Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Knees Both
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botox injection
Arm Type
Experimental
Arm Title
Genicular Radio frequency
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Botox Injectable Product
Intervention Description
Intra articular Botox injection
Intervention Type
Device
Intervention Name(s)
Radiofrequancy
Intervention Description
Genicular nerves radiofrequancy
Primary Outcome Measure Information:
Title
Pain visual analog scale
Description
0-10 Visual analog scale( less than 3 no pain 3-5 in pain, more than 5 sever pain
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
osteoarthritis
Exclusion Criteria:
coagulopathy Organ failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdallah Allam
Organizational Affiliation
Physical medicine Tanta university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rasha Gaber
Organizational Affiliation
Biochemistry Tanta university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ke Vin
Organizational Affiliation
Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Manal Hassanien
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Intra Articular Botox Injection in Treatment of Osteoarthritis
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