Back to resultsPlatelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis
Primary Purpose
Osteo Arthritis Knee, Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
radiofrequency
platelet rich plasma injection
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee
Eligibility Criteria
Inclusion Criteria:
- osteoarthritis knee
Exclusion Criteria:
- coaguloapthy
- patient refusal
Sites / Locations
- Emad Zarief Kamel Said
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
radiofrequency
intra-articular platelet rich plasma
Arm Description
genicular nerves pulsed radiofrequency
injection of platelet rich plasma in the affected joint
Outcomes
Primary Outcome Measures
pain visual analog scale
assessment of visual analog scale (VAS) VAS of zero means no pain, and 10 means sever pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03886142
Brief Title
Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis
Official Title
Efficacy of Genicular Nerve Radiofrequency Ablation Versus Intra-Articular Platelet Rich Plasma in Chronic Knee Osteoarthritis; a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients with chronic knee osteoarthritis non res ponders to conventional medical treatment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
radiofrequency
Arm Type
Active Comparator
Arm Description
genicular nerves pulsed radiofrequency
Arm Title
intra-articular platelet rich plasma
Arm Type
Active Comparator
Arm Description
injection of platelet rich plasma in the affected joint
Intervention Type
Procedure
Intervention Name(s)
radiofrequency
Intervention Description
radiofrequency of the genicular nerves
Intervention Type
Procedure
Intervention Name(s)
platelet rich plasma injection
Intervention Description
intra articular injection of platelet rich plasma
Primary Outcome Measure Information:
Title
pain visual analog scale
Description
assessment of visual analog scale (VAS) VAS of zero means no pain, and 10 means sever pain
Time Frame
12 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 knee
Exclusion Criteria:
coaguloapthy
patient refusal
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis
We'll reach out to this number within 24 hrs