- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04472702
Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel Herman, MD
- Phone Number: 916-734-6805
- Email: dcherman@ucdavis.edu
Study Contact Backup
- Name: Katherine Rizzone, MD
- Phone Number: 585-341-9407
- Email: katherine_rizzone@urmc.rochester.edu
Study Locations
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California
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Sacramento, California, United States, 95816
- Not yet recruiting
- UC Davis Health
-
Contact:
- Daniel Herman, MD
- Phone Number: 916-734-6805
- Email: dcherman@ucdavis.edu
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Principal Investigator:
- Daniel Herman, MD
-
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New York
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Rochester, New York, United States, 14627
- Recruiting
- University of Rochester
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Contact:
- Katherine Rizzone, MD
- Phone Number: 585-341-9407
- Email: katherine_rizzone@urmc.rochester.edu
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Principal Investigator:
- Katherine Rizzone, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1) patients of either gender with primary knee OA of one or both knees fulfilling the diagnostic criteria for knee OA by the American College of Rheumatology,
- 2) Kellgren-Lawrence score of two to four,
- 3) reported NPRS pain intensity of at least four on most or all days of the past week
- 4) pain resistant to conventional treatments which may include but is not limited to medications (e.g. acetaminophen, oral or topical non-steroidal anti-inflammatory drugs, opioids), physical therapy, and intra-articular injections (e.g. corticosteroids, hyaluronic acid, platelet-rich-plasma) for at least 3 months. In the case of bilateral knee OA, the most symptomatic knee will be treated and studied.
Exclusion Criteria:
- 1) age <35 years,
- 2) non-English speaking patients,
- 3) body mass index greater than 40,
- 4) previous radiofrequency ablation procedure for the knee,
- 5) active systemic or local infections at the site of needle/cRFA probe placement,
- 6) previous knee joint replacement surgery,
- 7) autoimmune or inflammatory cause of knee arthritis such as rheumatoid or psoriatic arthritis,
- 8) non-ambulatory patients,
- 9) patients who are unable to provide their own consent (e.g. dementia),
- 10) unstable medical or psychiatric illness,
- 11) patients with pacemakers, spinal cord stimulators, deep brain stimulators, or similar devices,
- 12) patients seeking care as a part of workman's compensation or have litigation pending
- 13) a negative response to diagnostic geniculate nerve lidocaine injections.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subjects with knee OA using ultrasound for cRFA intervention
Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to ultrasound (N=45) cRFA treatment arm.
|
cRFA intervention will occur under sterile conditions, the patient will be placed in a supine position on a table and a bolster to provide flexion in the treated knee joint.
Skin and soft tissues will be anaesthetized with 2 mL 1% lidocaine at each of the three anatomic sites for cRFA, and a introducer needle will then be placed under ultrasound or fluoroscopic guidance to the SLG, SMG, and IMG nerves.
Adjustments at these positions will be made when using ultrasound guidance in order to capture the geniculate nerve if the nerve and/or its accompanying vasculature can be directly visualized using greyscale or Doppler modes.
When using ultrasound, the physician will note and record whether their positioning of the needle is based on bony landmarks, direct visualization of the nerve, and/or vascularity accompanying the nerve.
Once the introducer needle is placed, the cRFA will be placed into the introducer needle.
|
Experimental: Subjects with knee OA using fluoroscopy for cRFA intervention
Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to fluoroscopic (N=45) cRFA treatment arm.
|
cRFA intervention will occur under sterile conditions, the patient will be placed in a supine position on a table and a bolster to provide flexion in the treated knee joint.
Skin and soft tissues will be anaesthetized with 2 mL 1% lidocaine at each of the three anatomic sites for cRFA, and a introducer needle will then be placed under ultrasound or fluoroscopic guidance to the SLG, SMG, and IMG nerves.
Adjustments at these positions will be made when using ultrasound guidance in order to capture the geniculate nerve if the nerve and/or its accompanying vasculature can be directly visualized using greyscale or Doppler modes.
When using ultrasound, the physician will note and record whether their positioning of the needle is based on bony landmarks, direct visualization of the nerve, and/or vascularity accompanying the nerve.
Once the introducer needle is placed, the cRFA will be placed into the introducer needle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale
Time Frame: Baseline up to 24 months
|
The objective is to rate patient's reported pain.
The NPRS asks for a number between zero and ten that fits best to the subject's pain intensity, with zero as "no pain at all" and ten representing "the worst pain ever possible".
It has a similar minimal clinically significant difference (20%) as the visual analog scale and can be administered via a phone interview.
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Baseline up to 24 months
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Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: Baseline up to 24 months
|
The objective is to measure the patient's reported functional status.The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores |
Baseline up to 24 months
|
PROMIS - Depression
Time Frame: Baseline up to 24 months
|
The objective is to measure items relevant to the subject's mood, views of self, and engagement.
The test version 8b has good responsiveness with a minimally important difference range of 3-3.1 in adults with knee OA.
|
Baseline up to 24 months
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PROMIS - Pain Interference
Time Frame: Baseline up to 24 months
|
The objective is to measure the consequences of pain on the subject's life with a minimally important difference range of 2.35 to 2.4
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Baseline up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-Second Chair Stand Test
Time Frame: The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
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The objective is to determine the maximum number of chair stand repetitions possible in a 30 second period.
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The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
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Stair Climb Test
Time Frame: The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
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The objective is to determine the time (seconds) it takes to ascend and descend a flight of stairs.
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The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
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40m Fast Paced Walk Test
Time Frame: The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
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The objective is to determine the time (seconds) it takes to complete a fast-paced walking task over 4x10m (total 40m).
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The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
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Timed Up and Go Test48
Time Frame: The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
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The objective is to determine the time (seconds) to rise from a chair, walk 3m, turn, walk back to the chair, and then sit down.
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The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
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Six Minute Walk Test
Time Frame: The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
|
The objective is to determine the maximal distance covered in a 6min period.
|
The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Herman, MD, University of California, Davis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1868999
- STUDY00005460 (Other Identifier: University of Rochester)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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