Radiofrequency Ablation for Chronic Knee Pain

(RACKTKA Trial)

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

14 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Genicular Nerve Radiofrequency Ablation for chronic knee pain?

Research shows that genicular nerve radiofrequency ablation is a promising treatment for chronic knee pain, especially due to osteoarthritis, with consistent improvements in pain and function lasting up to 24 months and minimal side effects. ^{1 2 3 4 5}

Is radiofrequency ablation for chronic knee pain safe?

Radiofrequency ablation for chronic knee pain is generally considered safe, with studies showing minimal adverse events. It is a less invasive option compared to surgery and has been used effectively for knee osteoarthritis pain. ^{1 3 4 6 7}

How is genicular nerve radiofrequency ablation different from other treatments for chronic knee pain?

Genicular nerve radiofrequency ablation is unique because it targets specific nerves in the knee using heat to reduce pain, offering relief for up to 24 months with minimal side effects, especially for those who haven't found success with other treatments and want to avoid surgery. ^{1 3 4 5 6}

What is the purpose of this trial?

The purpose of this study is to assess how clinically useful and safe genicular nerve radiofrequency ablation is in people with chronic pain after total knee arthroplasty performed for osteoarthritis.

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)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Knee Ablation Approaches. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A retrospective study on patients with chronic knee pain treated with ultrasound-guided radiofrequency of the genicular nerves (RECORGEN trial). [2022]

3. England pubmed.ncbi.nlm.nih.gov

Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain Using a Three-Tined Electrode: A Technical Description and Case Series. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Technical considerations for genicular nerve radiofrequency ablation: optimizing outcomes. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic Knee Osteoarthritis: A Single-Blind Randomized Controlled Trial. [2022]