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Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cRFA
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

35 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UC Davis Health
  • University of RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Subjects with knee OA using ultrasound for cRFA intervention

Subjects with knee OA using fluoroscopy for cRFA intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
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.
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
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
PROMIS - Depression
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.
PROMIS - Pain Interference
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

Secondary Outcome Measures

30-Second Chair Stand Test
The objective is to determine the maximum number of chair stand repetitions possible in a 30 second period.
Stair Climb Test
The objective is to determine the time (seconds) it takes to ascend and descend a flight of stairs.
40m Fast Paced Walk Test
The objective is to determine the time (seconds) it takes to complete a fast-paced walking task over 4x10m (total 40m).
Timed Up and Go Test48
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.
Six Minute Walk Test
The objective is to determine the maximal distance covered in a 6min period.

Full Information

First Posted
July 10, 2020
Last Updated
November 9, 2022
Sponsor
University of California, Davis
Collaborators
American Medical Society for Sports Medicine Collaborative Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT04472702
Brief Title
Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial
Official Title
Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
American Medical Society for Sports Medicine Collaborative Research Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a promising treatment option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is the typical guidance of choice, but uses bony landmarks to target these nerves which have variable positions around the knee. Alternatively, ultrasound allows for targeting based on visualization of bony landmarks, the nerves, and their accompanying vascular structures, and thus may offer greater accuracy. However, there are few studies which directly compare the clinical efficacy of these two guidance options. This study will compare these two options.
Detailed Description
Background: Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a promising treatment option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is the typical guidance of choice, but uses bony landmarks to target these nerves which have variable positions around the knee. Alternatively, ultrasound allows for targeting based on visualization of bony landmarks, the nerves, and their accompanying vascular structures, and thus may offer greater accuracy. However, there are few studies which directly compare the clinical efficacy of these two guidance options. Objective: To compare the effectiveness of geniculate nerve cRFA on knee osteoarthritis outcomes when using either ultrasound or fluoroscopic guidance. The primary outcome measures will be patient pain levels and patient-reported function. The secondary outcome measures will be objective performance-based functional outcomes. The exploratory outcome measures will be blood biomarkers of inflammation, extracellular matrix turnover, and cartilage degradation. Methods: 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) or ultrasound (N=45) cRFA treatment arms. Baseline assessments will include 1) Numeric Pain Rating Scale, Western Ontario and McMaster Universities Osteoarthritis Index, and PROMIS depression and pain interference measures; 2) the Osteoarthritis Research Society International recommended physical performance assessments including the 30-Second Chair Stand Test, Stair Climb Test, 40m Fast Paced Walk Test, Timed Up and Go Test, and Six Minute Walk Test; and 3) in a subset of patients (N=24), blood biomarkers including MMP-3, IL-1β, TNF-α, COMP, and CTX-II. These measures will be re-assessed at one month (pain and patient-reported function only, via phone contact), three months, and 6 months after the cRFA procedure. Study endpoints will be assessed using a mixed model repeated measures analysis of variance using an alpha level of 0.05. Statement of Relevance: Knee osteoarthritis patients are commonly treated by sports medicine providers, who are typically well-trained in the use of ultrasound. Should ultrasound be demonstrated as effective for cRFA, sports medicine providers would be well-positioned to use relatively low-cost and accessible imaging technology to significantly improve patient pain and function using cRFA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants (N=90; 45 at each site) will be randomized with equal probability to either treatment group, restricted by equal enrollment and equal distribution at each site. Patients will be enrolled for the exploratory aim separately at the University of Florida site only. After enrollment into the main study (primary and secondary aims), subjects at the UF site will be offered enrollment into the exploratory aim (N=24) on a consecutive basis restricted by equal enrollment into each treatment arm. A random number table will be used for group allocation and the values recorded separately into opaque, sealed envelopes. This will be performed by a clinical coordinator who is not involved in study to ensure allocation concealment. Outcomes for the primary, secondary, and exploratory aims will be completed by research staff who are blinded to the subject treatment allocation. Data analyses will also be completed in a blinded fashion by the study statistical consultant.
Masking
Investigator
Masking Description
A random number table will be used for group allocation and the values recorded separately into opaque, sealed envelopes. This will be performed by a clinical coordinator who is not involved in study to ensure allocation concealment. Outcomes for the primary, secondary, and exploratory aims will be completed by research staff who are blinded to the subject treatment allocation. Data analyses will also be completed in a blinded fashion by the study statistical consultant.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects with knee OA using ultrasound for cRFA intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Subjects with knee OA using fluoroscopy for cRFA intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
cRFA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
Baseline up to 24 months
Title
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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
Time Frame
Baseline up to 24 months
Title
PROMIS - Depression
Description
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.
Time Frame
Baseline up to 24 months
Title
PROMIS - Pain Interference
Description
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
Time Frame
Baseline up to 24 months
Secondary Outcome Measure Information:
Title
30-Second Chair Stand Test
Description
The objective is to determine the maximum number of chair stand repetitions possible in a 30 second period.
Time Frame
The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
Title
Stair Climb Test
Description
The objective is to determine the time (seconds) it takes to ascend and descend a flight of stairs.
Time Frame
The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
Title
40m Fast Paced Walk Test
Description
The objective is to determine the time (seconds) it takes to complete a fast-paced walking task over 4x10m (total 40m).
Time Frame
The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
Title
Timed Up and Go Test48
Description
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.
Time Frame
The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
Title
Six Minute Walk Test
Description
The objective is to determine the maximal distance covered in a 6min period.
Time Frame
The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Herman, MD
Phone
916-734-6805
Email
dcherman@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Rizzone, MD
Phone
585-341-9407
Email
katherine_rizzone@urmc.rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Herman, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Herman, MD
Phone
916-734-6805
Email
dcherman@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Daniel Herman, MD
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Rizzone, MD
Phone
585-341-9407
Email
katherine_rizzone@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Katherine Rizzone, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial

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