Heat therapy for knee pain: new study tests Nerve-Burning procedure after failed replacements
NCT ID NCT05283889
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a procedure called genicular radiofrequency ablation can safely reduce persistent knee pain in people who still hurt more than a year after total knee replacement. The procedure uses heat to temporarily calm specific nerves around the knee. Half of the 44 participants will get the real procedure, and half will get a sham (fake) version, so researchers can see if the real treatment truly helps more than a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Genicular radiofrequency ablation (a procedure that uses heat to calm pain-sensing nerves around the knee)
- What this could lead to
- If it works, this could offer a minimally invasive option to reduce chronic pain and improve function for people whose knee replacement still hurts.
- What could go wrong
- This is a small, early-stage trial with only 44 participants, so results may not apply to everyone. The procedure carries risks like nerve damage or infection, and the sham comparison means some benefit could be due to placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2022
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * \>1 year post TKA * persistent knee pain \> 4/10 in intensity on average over the prior week of one of the post-TKA knees * refractory to conventional treatment (i.e., physiotherapy, medication, etc.) * ≥80% pain relief with a single fluoroscopically guided local anesthetic block using 0.5 mL of 2% lidocaine for the medial and lateral branches of the nerve to the vastus intermedialis, nerve to the vastus lateralis\*, inferior medial genicular nerve, infrapatellar branch of the saphenous nerve, and the recurrent fibular nerve. 0.5 mL will be injected over 2 spots (1.5 cm apart) for each of the superior medial and lateral genicular nerves corresponding to the sites of the RF cannulae for the bipolar strip lesions. \*Blocks will be combined fluoroscopy/ultrasound guided. Exclusion Criteria: * Infection (peri-prosthetic, joint, systemic, skin/soft tissue overlying the knee to be treated) * Prosthetic loosening or failure, periprosthetic fracture * Severe psychiatric disorder * Non-genicular lower extremity pain source from the spine (i.e., radiculopathy or neurogenic claudication) or peripheral joints (i.e., hip osteoarthritis) * Peripheral vascular disease causing vascular claudication * Connective tissue/inflammatory joint disease/widespread soft tissue pain disorder * Poor tolerance of injection procedures (as observed from the prognostic local anesthetic blocks) * Allergy to local anesthetic, synovial expansion into the anticipated path(s) of the local anesthetic needle/RF cannula as determined by ultrasound scanning * Uncontrolled bleeding diathesis * Pregnancy * Pacemaker or neurostimulator * Inability to complete Patient-Reported Outcome Measures due to cognitive or language limitations.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Osteoarthritis, knee are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Vivo Cura Health
Calgary, Alberta, T2E2P5, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which anesthesia gets joint replacement patients moving sooner?
- Can a special MRI match CT for spotting knee bone damage?
- Can a common bleeding drug make knee realignment surgery safer?
- One shot, new knee? gene therapy trial aims to quiet arthritis pain
- Three knee shots go Head-to-Head for lasting arthritis relief
- Gel shot vs standard injection: which quiets arthritic knees?