Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration
A Single Blinded Randomized Controlled Clinical Trial Comparing Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration
1 other identifier
interventional
40
1 country
1
Brief Summary
A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
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
June 9, 2021
CompletedFirst Posted
Study publicly available on registry
June 28, 2021
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 9, 2022
May 1, 2022
2 months
June 9, 2021
May 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in chronic knee pain
Measured by the Knee injury and Osteoarthritis Outcome Score; higher scores indicating that the patients experiences more impairment (All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale; 0 representing extreme knee problems and 100 representing no knee problems).
2nd and 6th week
Study Arms (2)
radiofrequency with corticosteroids
ACTIVE COMPARATORcorticosteroids- 80mg depo-medrol Pulsed radiofrequency to 42 derees celsius for 6 minutes
radiofrequency without corticosteroids
ACTIVE COMPARATORPulsed radiofrequency to 42 derees celsius for 6 minutes
Interventions
a percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications.
Eligibility Criteria
You may qualify if:
- Men and women with pain secondary to osteoarthritis of the knee
- Age of 18 years and up
- Fits criteria for procedure of genicular nerve block and pulsed radiofrequency neuromodulation
You may not qualify if:
- Patients who are incapable of judgment and/or to give informed consent
- Patients who are pregnant
- Patients who are under 18 years old
- Patients who have allergies to local anesthetic
- Patients with platelet dysfunction or bleeding disorders
- Patients who are currently mentally unstable
- Patients who have a diagnosis of fibromyalgia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Tel Litwinsky, Israel
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 GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor Head of Pain Clinics, Sheba Medical Center
Study Record Dates
First Submitted
June 9, 2021
First Posted
June 28, 2021
Study Start
April 1, 2022
Primary Completion
June 1, 2022
Study Completion
December 1, 2022
Last Updated
May 9, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share