Back to resultsThe Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, radiofrequency ablation
Eligibility Criteria
Inclusion Criteria:
- Stage 3 and 4 knee osteoarthritis according to Kellgren-Lawrance scale
- Knee pain more than 3 months
Exclusion Criteria:
- Neurological diseases such as polyneuropathies
- Presence of severe psychiatric disorders
- Hemodynamic instability
- History of any surgery from the knee
Sites / Locations
- Marmara University School of Medicine Department of Physical Medicine and RehabilitationRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Genicular RF
Arm Description
Patients who will receive genicular radiofrequency ablation
Outcomes
Primary Outcome Measures
Visual analogue scale
The change of pain will be evaluated with 10 cm visual analogue scale will be applied to the patients, 0 being no pain while 10 being intolerable pain
Secondary Outcome Measures
Postural stability
The change of weight bearing indexes of both feet will be measured
WOMAC
Western Ontario & McMaster Universities Osteoarthritis Index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03816124
Brief Title
The Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis
Official Title
The Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara 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
In advanced knee osteoarthritis, postural stability is also disturbed. There are some concerns about performing radiofrequency ablation to genicular nerves since this may further decrease the postural stability of the patient. The aim of this study is to see if application of genicular radiofrequency causes a significant change in postural stability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
osteoarthritis, radiofrequency ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with knee osteoarthritis with Kellgren-Lawrance scale stage 3-4 will receive radiofrequency ablation to their genicular nerves and will be evaluated before treatment, 3 weeks and 3 months after treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Genicular RF
Arm Type
Experimental
Arm Description
Patients who will receive genicular radiofrequency ablation
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Description
radiofrequency ablation of the genicular nerves
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
The change of pain will be evaluated with 10 cm visual analogue scale will be applied to the patients, 0 being no pain while 10 being intolerable pain
Time Frame
3 weeks and 3 months after the intervention
Secondary Outcome Measure Information:
Title
Postural stability
Description
The change of weight bearing indexes of both feet will be measured
Time Frame
3 weeks and 3 months after the treatment
Title
WOMAC
Description
Western Ontario & McMaster Universities Osteoarthritis Index
Time Frame
3 weeks and 3 months after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Stage 3 and 4 knee osteoarthritis according to Kellgren-Lawrance scale
Knee pain more than 3 months
Exclusion Criteria:
Neurological diseases such as polyneuropathies
Presence of severe psychiatric disorders
Hemodynamic instability
History of any surgery from the knee
Facility Information:
Facility Name
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozge Kenis-Coskun, MD
Phone
5058294947
Email
ozgekenis@gmail.com
First Name & Middle Initial & Last Name & Degree
MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis
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