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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

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Knees Both Drug: Botox Injectable Product Device: Radiofrequancy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Intraarticular Botox Injection Versus Genicular Pulsed Radio Frequency in Treatment of Patients With Osteoarthritis
Actual Study Start Date : October 20, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Osteoarthritis

Arm Intervention/treatment
Experimental: Botox injection Drug: Botox Injectable Product
Intra articular Botox injection

Active Comparator: Genicular Radio frequency Device: Radiofrequancy
Genicular nerves radiofrequancy




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • osteoarthritis

Exclusion Criteria:

  • coagulopathy Organ failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891680


Contacts
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Contact: Manal Hassanien 01062679200 manal_hassanien@yahoo.com
Contact: Abdelraheem M Alawamy manal_hassanien@yahoo.com

Locations
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Egypt
Manal Hassanien Recruiting
Assiut, Egypt
Contact: Manal M Hassanien         
Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Abdallah Allam Physical medicine Tanta university
Study Chair: Rasha Gaber Biochemistry Tanta university
Study Chair: Ke Vin Taiwan
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Responsible Party: Manal Hassanien, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT03891680    
Other Study ID Numbers: Botox in osteoarthritis
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases