Back to resultsRadio-frequency Ablation in Knee Osteoarthritis by Three Needles Technique
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Radio-frequency ablation of genicular nerves
Sponsored by
About this trial
This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Genicular nerve radio-frequency ablation
Eligibility Criteria
Inclusion Criteria:
- 1- Age 35-85 years old 2- Patients with stage 3 or higher OA-related radiological changes based on Kellgren-Lawrence (K/L) rating scale 3- Knee pain for at least 3 months 4-Patients are clinically unresponsive to conservative treatment modalities (physical therapy and rehabilitation practices, orally administered analgesics and anti-inflammatory drugs).
Exclusion Criteria:
1- Patients with other causes of pain as radiculopathy, neurological disorders or intermittent claudication. 2- Previous knee trauma. 3- Previous knee surgery. 4- Patients received intra-articular injection during the previous three months.
5- Acute knee pain. 6- Crystal arthropathy. 7- Joint effusion. 8- Serious neurological or psychiatric disorders. 9- On anticoagulant medication. 10- Any other connective tissue disorder that affects the knee joint. 11- skin infection at the site of injection. 12-patient refusal.
Sites / Locations
- Faculty of Medicine, minia university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Three needles group
Single needle group
Arm Description
Outcomes
Primary Outcome Measures
Visual analogue score
Pain intensity via the visual analogue score (VAS).
Oxford knee score
Follow up of pain and function via the Oxford knee score
Secondary Outcome Measures
Failure rate
Persistence of pain after the procedure
Incidence of complication
Any infection, heamatoma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03613610
Brief Title
Radio-frequency Ablation in Knee Osteoarthritis by Three Needles Technique
Official Title
Three Needles Approach... A New Technique of Genicular Nerve Radio-frequency Ablation for Pain Relief in Advanced Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alaa Fouli Gaber Ebrahim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study is designed to evaluate and compare the efficacy of three needles approach as a new technique in radiofrequency neurotomy of genicular nerve versus the traditional single needle approach as a treatment of advanced knee osteoarthritic pain. Primary outcome:
Pain intensity via the visual analogue score (VAS).
Function and pain via the Oxford Knee Score. Evaluated after 6 months of the procedure
Secondary outcome:
Failure rate.
Incidence of any complication.
Total analgesic requirement during the period of follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Genicular nerve radio-frequency ablation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Three needles group
Arm Type
Active Comparator
Arm Title
Single needle group
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
Radio-frequency ablation of genicular nerves
Intervention Description
Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis
Primary Outcome Measure Information:
Title
Visual analogue score
Description
Pain intensity via the visual analogue score (VAS).
Time Frame
6 months after the procedure
Title
Oxford knee score
Description
Follow up of pain and function via the Oxford knee score
Time Frame
6 months after the procedure
Secondary Outcome Measure Information:
Title
Failure rate
Description
Persistence of pain after the procedure
Time Frame
6 months after the procedure
Title
Incidence of complication
Description
Any infection, heamatoma
Time Frame
6 months after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1- Age 35-85 years old 2- Patients with stage 3 or higher OA-related radiological changes based on Kellgren-Lawrence (K/L) rating scale 3- Knee pain for at least 3 months 4-Patients are clinically unresponsive to conservative treatment modalities (physical therapy and rehabilitation practices, orally administered analgesics and anti-inflammatory drugs).
Exclusion Criteria:
1- Patients with other causes of pain as radiculopathy, neurological disorders or intermittent claudication. 2- Previous knee trauma. 3- Previous knee surgery. 4- Patients received intra-articular injection during the previous three months.
5- Acute knee pain. 6- Crystal arthropathy. 7- Joint effusion. 8- Serious neurological or psychiatric disorders. 9- On anticoagulant medication. 10- Any other connective tissue disorder that affects the knee joint. 11- skin infection at the site of injection. 12-patient refusal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omyma Sh Mohamed, Ass. prof.
Organizational Affiliation
Minia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
And El raheem Ma Mohamed, Lecturer
Organizational Affiliation
Assist university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sarah Mo Omar, Lecturer
Organizational Affiliation
Minia University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alaa Fo Gaber, Resident
Organizational Affiliation
Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, minia university
City
Minya
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Radio-frequency Ablation in Knee Osteoarthritis by Three Needles Technique
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