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Intra Articular Botox Injection in Treatment of Osteoarthritis (Osteoarthritis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891680
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Manal Hassanien, Assiut University

Tracking Information
First Submitted Date  ICMJE March 23, 2019
First Posted Date  ICMJE March 27, 2019
Last Update Posted Date February 18, 2020
Actual Study Start Date  ICMJE October 20, 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra Articular Botox Injection in Treatment of Osteoarthritis
Official Title  ICMJE Comparison Between Intraarticular Botox Injection Versus Genicular Pulsed Radio Frequency in Treatment of Patients With Osteoarthritis
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis Knees Both
Intervention  ICMJE
  • Drug: Botox Injectable Product
    Intra articular Botox injection
  • Device: Radiofrequancy
    Genicular nerves radiofrequancy
Study Arms  ICMJE
  • Experimental: Botox injection
    Intervention: Drug: Botox Injectable Product
  • Active Comparator: Genicular Radio frequency
    Intervention: Device: Radiofrequancy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • osteoarthritis

Exclusion Criteria:

  • coagulopathy Organ failure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Manal Hassanien 01062679200 manal_hassanien@yahoo.com
Contact: Abdelraheem M Alawamy manal_hassanien@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03891680
Other Study ID Numbers  ICMJE Botox in osteoarthritis
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manal Hassanien, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Abdallah Allam Physical medicine Tanta university
Study Chair: Rasha Gaber Biochemistry Tanta university
Study Chair: Ke Vin Taiwan
PRS Account Assiut University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP