Efficacy of Genicular Nerve Radiofrequency
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable chronic-pain
Started Sep 2019
Shorter than P25 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2019
CompletedStudy Start
First participant enrolled
September 20, 2019
CompletedFirst Posted
Study publicly available on registry
September 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2019
CompletedSeptember 24, 2019
September 1, 2019
14 days
September 17, 2019
September 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at first 3 months
Secondary Outcomes (1)
Ultrasound versus fluoroscopy
at first 3 months
Study Arms (2)
Operated
EXPERIMENTALGenicular block will aply to the patients with knee pain who was operated before
Nonoperated
SHAM COMPARATORGenicular block will aply to the patients with knee pain who wasn't operated before
Interventions
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
Eligibility Criteria
You may qualify if:
- knee pain
You may not qualify if:
- with communication problems (VAS and WOMAC scores could not be evaluated)
- infectious-mechanical pain-related conditions,
- with radicular pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diskapi Teaching and Research Hospital
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital
Study Record Dates
First Submitted
September 17, 2019
First Posted
September 24, 2019
Study Start
September 20, 2019
Primary Completion
October 4, 2019
Study Completion
November 4, 2019
Last Updated
September 24, 2019
Record last verified: 2019-09