Radiofrequency Ablation for Chronic Knee Pain

(RACKTKA Trial)

Not currently recruiting at 1 trial location

Overseen By Timothy E McAlindon, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Infection, Posterior knee pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of genicular nerve radiofrequency ablation for individuals with ongoing knee pain after knee replacement surgery due to osteoarthritis. The trial compares this treatment to a placebo to determine its potential in reducing pain. Suitable candidates have experienced persistent knee pain for at least one month within the past six months and find their current knee condition unacceptable. As an unphased trial, it offers patients the chance to contribute to valuable research that could lead to new pain management solutions.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulants (blood thinners) for three days before the procedure, with approval from your doctor. Other medications are not specifically mentioned, so it's best to discuss with the study team.

What prior data suggests that genicular nerve radiofrequency ablation is safe for chronic knee pain?

Research has shown that genicular nerve radiofrequency ablation, a procedure using heat to target nerves, is generally safe for treating long-term knee pain, especially after knee surgery for arthritis. Most studies report significant and lasting pain relief, with many patients experiencing improvement for over 18 months.

However, targeting the lower outer part of the knee poses a potential risk. This area is near the common fibular nerve, which might be affected. Despite this, most people tolerate the procedure well, and serious side effects are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about genicular nerve radiofrequency ablation for chronic knee pain because it offers a novel approach by directly targeting the nerves responsible for transmitting pain. Unlike traditional treatments like medication, physical therapy, or even surgery, this technique uses precise radiofrequency energy to disrupt pain signals without invasive procedures. This method has the potential to provide longer-lasting relief with fewer side effects compared to standard options. By focusing on nerve pathways, it offers a promising alternative for those who haven't found success with other treatments.

What evidence suggests that genicular nerve radiofrequency ablation is effective for chronic knee pain?

Research has shown that genicular nerve radiofrequency ablation, a simple procedure using heat to target knee nerves, can greatly reduce knee pain. In one study, about 65% of participants reported their pain was cut in half. Another study found that more than half of the patients felt a noticeable improvement in their physical health after the treatment. Long-term results showed significant pain relief lasting 18 months or more. In this trial, participants will either undergo genicular nerve radiofrequency ablation or a sham procedure. These findings suggest that this treatment could be effective for people with ongoing knee pain after surgery for osteoarthritis. ^{3 5 6 7 8}

Who Is on the Research Team?

Timothy E McAlindon, MD, MPH

Principal Investigator

UMass Worcester (UMass Chan Medical School)

Phibi E Ngankam, BS

Principal Investigator

UMass Worcester (UMass Chan Medical School)

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had knee replacement surgery at least a year ago and are in good health except for chronic knee pain. They must find their current state unacceptable, be willing to track pain daily, and not be on anticoagulants or pregnant. Those with infection in the knee or loose prosthesis, exclusive posterior knee pain, or less than 70% pain reduction after a test block can't join.

Inclusion Criteria

Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed

I am willing to follow all study procedures and report my pain, side effects, and medication use daily.

It has been over a year since my knee replacement surgery.

Exclusion Criteria

Participation in a clinical research trial that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 30 days prior to the Screening Visit, or planned participation in any such trial

My knee pain is only in the back of my knee.

I am not pregnant, breastfeeding, and I am either post-menopausal or have had surgery to prevent pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo genicular nerve radiofrequency ablation or sham procedure

6 months

1-, 3-, and 6-month visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1-, 3-, and 6-month visits

What Are the Treatments Tested in This Trial?

Interventions

• Genicular Nerve Radiofrequency Ablation
• Sham

Trial Overview The study tests genicular nerve radiofrequency ablation's effectiveness and safety against a sham procedure (placebo) in reducing chronic pain after total knee arthroplasty due to osteoarthritis. Participants will record their daily pain levels to measure outcomes.

How Is the Trial Designed?

Group I: Radiofrequency Ablation Active Control 1 Intervention

Patient undergoing genicular nerve radiofrequency ablation.

Group II: Sham Placebo Group 1 Intervention

Patient undergoing sham.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Tufts Medical Center

Collaborator

Trials

264

Recruited

264,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Rheumatology Research Foundation

Collaborator

Trials

14

Recruited

8,200+

Published Research Related to This Trial

A novel protocol for genicular nerve radiofrequency ablation (RFA) targeting additional articular branches resulted in significant pain relief for 91% of patients at one month, with improvements sustained at six months.

The study involved 11 patients with chronic knee pain, and notably, there were no complications reported, indicating the safety of this new approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain Using a Three-Tined Electrode: A Technical Description and Case Series. Koshi, E., Cheney, CW., Sperry, BP., et al.[2021]

In a study involving 9 patients with medial knee osteoarthritis, ultrasound-guided genicular nerve pulsed radiofrequency treatment significantly reduced pain levels, as measured by the visual analog scale (VAS), over a 3-month period.

The treatment also led to notable improvements in knee function, assessed using the WOMAC index, indicating that genicular nerve pulsed RF is a promising and safe option for managing osteoarthritis-related knee pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. Kesikburun, S., Yaşar, E., Uran, A., et al.[2022]

Genicular nerve radiofrequency ablation is a treatment option for patients with osteoarthritic knee pain who do not respond to conservative or minimally invasive treatments.

The article discusses the procedure's effectiveness, patient selection criteria, and potential risks and complications, highlighting its role in managing chronic knee pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular nerve radiofrequency ablation: An option for knee osteoarthritis pain. Swanson, JL.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37428157/

Genicular nerve radiofrequency ablation for the treatment ... In this real-world cohort, approximately half of the participants experienced clinically meaningful improvements in knee pain after GNRFA at an average follow- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11411598/

Long-term clinical outcomes of genicular nerve ... An expanded genicular nerve ablation protocol captures 6 nerves. This protocol resulted in significant long-term (≥18 months) improvements in pain.

3. academic.oup.com academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaf115/8241057?searchresult=1

Effectiveness of genicular nerve radiofrequency ablation in ... Using a modified intention to treat analysis, 65% (95% CI: 41%-83%) of participants in the GnRFA group demonstrated ≥50% pain relief, compared to 11% (95% CI: 3 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772594424001602

Evaluating the effectiveness of genicular radiofrequency ... In this real-world cross-sectional cohort study, over 56 % of participants experienced improvment ≥ MCID on PROMIS-GH-PH after undergoing GFRNA for chronic knee ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/17581869.2025.2567833?src=

Patient reported outcomes following genicular nerve radio ... Genicular radiofrequency ablation (RFA) is a minimally invasive treatment for knee pain with variable outcomes reported. This study aimed to evaluate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11882468/

Genicular Nerve Radiofrequency Ablation for Chronic ... GNRFA using a V-shaped active tip needle is a promising intervention for chronic knee pain, offering significant and sustained pain relief and functional ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772594423000791

The safety and efficacy of genicular nerve radiofrequency ... This procedure has been proven to be safe, except in the inferior lateral quadrant (ILQ) due to its innervation being near the common fibular nerve (CFN). Given ...

8. academic.oup.com academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaf140/8277929

Efficacy and safety of genicular nerve ablation techniques for ... Compared with sham, ablative techniques significantly reduced pain at 12 weeks (MD −1.65; 95% CI, −2.57 to −0.74; I2 = 83%) and improved WOMAC ...