Principal Investigator: Zachary McCormick
Keywords: Osteoarthritis , Genicular Radiofrequency Ablation , Cooled Radiofrequency Ablation , Standard Radiofrequency Ablation , Chronic knee pain Department: Physical Medicine & Rehab
IRB Number: 00124571
Specialty: Physical Medicine and Rehabilitation, Physical Medicine and Rehabilitation
Sub Specialties: Chronic Pain
Recruitment Status: Recruiting

Contact Information

Shellie Cunningham
shellie.cunningham@hsc.utah.edu
801-587-5488

Simple Summary

The purpose of this research study is to collect data on the safety and effectiveness of the two treatments being studied. If you decide to participate in this study, you will come into the clinic for a screening visit to see if you qualify. If you qualify and still want to join the study, you will come back for your Study Treatment Visit. You will be assigned randomly (like flipping a coin) to one of two groups:CRFA Treatment (Active Group)SRFA Treatment (Control Group)You will not know which group you are assigned, or which study treatment you receive.You will then return to the study doctor’s office at 1 month, 3 months, 6 months, 9 months,12 months,18 months, and 24 months after your study treatment visit. During each of your visits, a study team member will ask you to complete some questionnaires that measure your pain to see how the different study treatments are working.For all study participants, the study lasts 24 months (2 years).

Inclusion Criteria

Inclusion Criteria
1. Age ≥ 21 years
2. Able to understand and personally sign and date the informed consent form
3. Able to complete outcome measures
4. Chronic knee pain for longer than 6 months that interferes with functional
activities (for example, ambulation, prolonged standing, etc.)
5. Continued pain in the target knee despite at least 3 months of conservative
treatments, including activity modification, home exercise, protective weight
bearing, and/or analgesics (for example, acetaminophen or non-steroidal
anti-inflammatory drugs [NSAIDs])
6. Positive response (defined as a decrease in numeric pain scores of at least
50%) to a single genicular nerve block of the index knee
7. Pain on NRS ≥ 6 on an 11-point scale for the index knee
8. Radiologic confirmation of osteoarthritis (x-ray/MRI/CT) grade 2 (mild), 3
(moderate) or 4 (severe) noted within 6 months for the index knee
9. Analgesics including membrane stabilizers such as Neurontin (gabapentin)
and antidepressants for pain, such as Cymbalta (duloxetine), must be
clinically stable (defined as stable dosage for ≥ 6 weeks prior to the
screening visit) and shall not change during the course of the study without
approval of the investigator

10. Agree to see one physician (study physician) for knee pain during the study
period
11. Subjects of child bearing potential must be willing to utilize double barrier
contraceptive method
12. Willingness to comply with the requirements of this protocol for the full
duration of the study (24 months regardless of effect of initial therapy)

Exclusion Criteria

Exclusion Criteria
1. Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other
systemic inflammatory condition (example; gout, fibromyalgia, MS, Lupus,
etc.) that could cause knee pain
2. Evidence of neuropathic pain affecting the index knee
3. Previous or pending lower limb amputation
4. Intra-articular steroid injection into the index knee within 90 days from
randomization
5. Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or
arthroscopic debridement/lavage injection into the index knee within 180
days from randomization
6. Prior radiofrequency ablation of the genicular nerves of the index knee
7. Prior partial, resurfacing, or total knee arthroplasty of the index knee
(residual hardware)
8. Clinically significant ligamentous laxity of the index knee
9. Clinically significant valgus/varus deformities or evidence of pathology
(other than osteoarthritis of knee) that materially affects gait or function of
the knee or is the underlying cause of the knee pain and/or functional
limitations
10. Body mass index (BMI) > 40 kg/m2
11. Extremely thin patients and those with minimal subcutaneous tissue
thickness that would not accommodate a radiofrequency lesion of up to 14
mm in diameter to limit the risk of skin burns
12. Pending or active compensation claim, litigation, or disability remuneration
(secondary gain)
13. Pregnant, nursing or intent of becoming pregnant during the study period
14. Chronic pain associated with significant psychosocial dysfunction
15. Poorly controlled severe psychiatric illness or ongoing psychological barriers
to recovery, as determined by the investigator
16. Allergies to any of the medications to be used during the procedures
17. Active joint infection or systemic or localized infection at needle entry sites
(subject may be considered for inclusion once infection is resolved)
18. History of uncontrolled coagulopathy, ongoing coagulation treatment that
cannot be safely interrupted for procedure, or unexplained or uncontrollable
bleeding that is uncorrectable
19. Identifiable anatomical variability that would materially alter the procedure
as described in the protocol
20. Within the preceding 2 years, subject has suffered from active narcotic
addiction, substance, or alcohol abuse
21. Current prescribed opioid medications greater than 60 mg morphine
equivalent daily opioid dose
22. Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)
23. Subject currently implanted with pacemaker, stimulator or defibrillator
24. Participating in another clinical trial/investigation which included therapeutic
treatment within 30 days prior to signing informed consent
25. Subject unwilling or unable to comply with follow up schedule, protocol
requirements or procedures

Participant Reimbursement

Both procedures being studied are part of the available treatments for people with your condition. There will be no additional charge to you for being in this study.As part of the study, the sponsor will pay for your procedure study treatment. If subsequent or additional treatments are needed, while participating in the study, they will not be covered by the sponsor.You will not be charged, nor will your insurance company be charged, for any test or visit that is completed solely for the purpose of this study. All other standard of care treatment will go through your insurance company as normal billing procedures. It is not expected that you will incur any additional costs due to your participation in this research study.However, ask your study doctor to discuss the costs that will or will not be covered by the sponsor. This discussion should include the costs of treating possible side effects. Otherwise, you might have unexpected expenses from being in this study.There will be a total of 9 study visits. You will be given a $40.00 Amazon gift card as compensation after you completeVisit 1 (screening visit), Visit 2 (procedure visit) and upon completion offollow up Visit3, 4, 5, 6, and 8. You will receivean$85 Amazon gift card upon completion of follow up Visit 7(one yearvisit) and follow up Visit 9 (two yearvisit).You will only be paid for the visits you complete. A completed visit means all scheduled procedures and exams have been carried outand questionnaires answered.The total amount of compensation possible over the two year time period is $450