Efficacy of Genicular Nerve Radiofrequency
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Genicular block was applied
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Genicular nerve, Knee pain, Ultrasound
Eligibility Criteria
Inclusion Criteria:
- knee pain
Exclusion Criteria:
- with communication problems (VAS and WOMAC scores could not be evaluated)
- infectious-mechanical pain-related conditions,
- with radicular pain
Sites / Locations
- Diskapi Teaching and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Operated
Nonoperated
Arm Description
Genicular block will aply to the patients with knee pain who was operated before
Genicular block will aply to the patients with knee pain who wasn't operated before
Outcomes
Primary Outcome Measures
Post intervention analgesic effect
Post intervention analgesic effects of genicular block on patients will be recorded. Postoperative pain, digital evaluation scale (Visual analogue scale -VAS; 0= absence of pain, 100= unbearable pain) of all patients will be performed and recorded.
Secondary Outcome Measures
Ultrasound versus fluoroscopy
Western Ontario and Mc Masters Osteoarthritis index (VOMAC) will be used to evaluate functional status on the efficacy of Ultrasound and fluoroscopy use.VOMAC is a disease-specific score in which pain, stiffness and physical functions are evaluated. It consists of 24 questions, 5 of which are pain, 2 are stiffness and 17 are evaluating physical function. It has both total score and subgroups can be evaluated separately. Maximum scores were 20 for pain subgroup, 8 for stiffness and 68 for physical function. High scores indicate that the patient has poor values in that group.
Full Information
NCT ID
NCT04100707
First Posted
September 17, 2019
Last Updated
September 20, 2019
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04100707
Brief Title
Efficacy of Genicular Nerve Radiofrequency
Official Title
Efficacy of Genicular Nerve Radiofrequency in Patients With Knee Pain After Total Knee Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2019 (Anticipated)
Primary Completion Date
October 4, 2019 (Anticipated)
Study Completion Date
November 4, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
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
In patients with knee pain, local anesthetics and radiofrequency applications to superolateral, superomedial and inferomedial genicular nerves that innervate the knee joint are also preferred methods besides analgesic and physical therapy. When necessary, total knee replacement is the preferred method for primary knee arthrosis.
However, continuing knee pain is reported in approximately 20% of patients after total knee replacement. In similar cases; In the painful knees, the blockages of the genicular nerves are successfully applied.
In this study; the efficacy of imaging-guided radiofrequency application will be investigated in patients presenting with knee pain after total knee replacement.
Detailed Description
Although simple analgesic and physical therapy methods are applied, some patients suffer from pain. Genicular nerve blocks and radiofrequency methods are performed usually for this reason. This procedure is performed with ultrasound and / or fluoroscopy, sterile staining and covering of painful knee to the middle of thigh and leg, localization of superomedial, superolateral, inferomedial genicular nerves are tested and then conventional radiofrequency is applied to all 3 nerve regions.Fifty patients who had total knee prosthesis for gonarthrosis in the Orthopedics and Traumatology Clinic at least 3 months postoperatively had knee pain (infection, mechanical causes and radicular pain) were included in the study.The VAS and WOMAC values recorded at the time of application and the VAS and WOMAC values recorded at the 1st week, 1st month and 3rd month after the procedure will be used to evaluate the effectiveness of the method.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Genicular nerve, Knee pain, Ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Operated
Arm Type
Experimental
Arm Description
Genicular block will aply to the patients with knee pain who was operated before
Arm Title
Nonoperated
Arm Type
Sham Comparator
Arm Description
Genicular block will aply to the patients with knee pain who wasn't operated before
Intervention Type
Procedure
Intervention Name(s)
Genicular block was applied
Intervention Description
This procedure is performed with ultrasound and / or fluoroscopy, sterile staining and covering of painful knee to the middle of thigh and leg, localization of superomedial, superolateral, inferomedial genicular nerves are tested and then conventional radiofrequency is applied to all 3 nerve regions
Primary Outcome Measure Information:
Title
Post intervention analgesic effect
Description
Post intervention analgesic effects of genicular block on patients will be recorded. Postoperative pain, digital evaluation scale (Visual analogue scale -VAS; 0= absence of pain, 100= unbearable pain) of all patients will be performed and recorded.
Time Frame
at first 3 months
Secondary Outcome Measure Information:
Title
Ultrasound versus fluoroscopy
Description
Western Ontario and Mc Masters Osteoarthritis index (VOMAC) will be used to evaluate functional status on the efficacy of Ultrasound and fluoroscopy use.VOMAC is a disease-specific score in which pain, stiffness and physical functions are evaluated. It consists of 24 questions, 5 of which are pain, 2 are stiffness and 17 are evaluating physical function. It has both total score and subgroups can be evaluated separately. Maximum scores were 20 for pain subgroup, 8 for stiffness and 68 for physical function. High scores indicate that the patient has poor values in that group.
Time Frame
at first 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
knee pain
Exclusion Criteria:
with communication problems (VAS and WOMAC scores could not be evaluated)
infectious-mechanical pain-related conditions,
with radicular pain
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alp ALPTEKIN
Phone
+905322659406
Email
alptekinmd@yahoo.com
Facility Information:
Facility Name
Diskapi Teaching and Research Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alp Alptekin, MD
Phone
+90 312 5962370
Email
alptekinmd@yahoo.com
12. IPD Sharing Statement
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Efficacy of Genicular Nerve Radiofrequency
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