Comparing two types of radiofrequency treatments for chronic knee pain

Comparison of Conventional and Cooled Radiofrequency Treatment of the Genicular Nerves Versus Sham Procedure for Patients With Chronic Knee Pain: a Multicentre, Double Blind, Randomised Controlled Trial

This study is testing whether two different types of radiofrequency treatments can help people with chronic knee pain feel better when other treatments haven't worked.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ziekenhuis Oost-Limburg (other)
• Locations: 15 sites (Antwerp and 14 other locations)
• Trial ID: NCT05407610 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of conventional versus cooled radiofrequency ablation of the genicular nerves in patients suffering from chronic knee pain due to osteoarthritis or persistent postsurgical pain. The study will enroll approximately 400 patients who have not responded to conservative treatments over the past year. Participants will undergo a run-in period to optimize prior treatments before being randomly assigned to one of three groups: conventional RF, cooled RF, or a sham procedure. The trial will follow patients for two years to assess pain relief and functional outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic anterior knee pain lasting more than 12 months that has not improved with conventional treatments.

Not a fit: Patients with knee pain not related to osteoarthritis or persistent postsurgical pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief and improved quality of life for patients with chronic knee pain.

How similar studies have performed: Other studies have shown promising results with radiofrequency treatments for chronic pain, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Signed written informed consent must be obtained before any study assessment is performed.
* Adult patients (Age ≥ 18 years old).
* Chronic anterior knee pain (\> 12 months) that is moderate to severe (defined as NRS \> 4 on most or all days for the index knee either constantly or with motion at time of screening and, an average NRS score reported in the patient diary \>4 at the end of the run-in period).
* Unresponsive (meaning insufficient pain reduction or intolerance) to conventional treatments ongoing for at least 12 months prior to inclusion. Conventional treatments must include all of the following: active physiotherapy, pharmacological treatment of pain and intra-articular corticosteroid infiltration.
* Only for patients with Osteoarthritis (OA): Radiologic confirmation of knee osteoarthritis of grade 2 (mild), 3 (moderate) or 4 (severe) noted within 12 months prior to the screening for the index knee according the Kellgren Lawrence criteria diagnosed by an independent radiologist with experience in musculoskeletal imaging on radiography (Rx) or magnetic resonance imaging (MRI). If imaging will need to be performed at screening it is recommended to perform an MRI instead of Rx. Imaging with MRI will enable the independent radiologist to perform a better estimation of the grade of OA.
* Only for patients with Persistent Post-Surgical Pain (PPSP) after Total Knee Arthroplasty (TKA): Patients with PPSP\* after TKA need to have had a negative orthopaedic work-up

Exclusion Criteria:

* Local or systemic infection (bacteraemia).
* Evidence of inflammatory arthritis or an inflammatory systemic disease responsible for knee pain.
* Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, ...) in the index knee during the 3 months prior to procedure.
* Pregnant, nursing or planning to become pregnant before the study intervention. Participants who become pregnant after the study intervention during the follow-up period will not be excluded.
* Chronic widespread pain.
* Patients with unstable psychosocial disorder.
* Allergies to products used during the procedure (lidocaine, propofol, chlorhexidine).
* Uncontrolled coagulopathy defined as supratherapeutic dose of anticoagulation medication.
* Uncontrolled immune suppression.
* Participating in another clinical trial/investigation within 30 days prior to signing informed consent.
* Patient is currently implanted with a neurostimulator.
* Current radicular pain in index leg.
* Previous conventional or cooled radiofrequency of the index knee.
* Patients with bilateral knee pain defined as chronic knee pain (\> 12 months) in both knees that is moderate to severe (defined as a numeric rating scale (NRS) \> 4 on most or all days either constantly or with motion) and that is unresponsive (meaning insufficient pain reduction or intolerance) to conventional treatments ongoing for at least 12 months prior to inclusion. Conventional treatments must include all of the following: active physiotherapy, pharmacological treatment of pain and intra-articular corticosteroid infiltration.
* Patients who have a planned TKA in the near future defined as patients who already have agreed on a date for the TKA procedure.
* Patients who are unwilling or mentally incapable to complete the study questionnaires.

Where this trial is running

Antwerp and 14 other locations

• UZ Antwerpen — Antwerp, Belgium (RECRUITING)
• AZ Klina — Brasschaat, Belgium (ACTIVE_NOT_RECRUITING)
• ULB Erasme — Brussels, Belgium (RECRUITING)
• UCL Saint-Luc — Brussels, Belgium (ACTIVE_NOT_RECRUITING)
• Ziekenhuis Oost-Limburg AV — Genk, Belgium (RECRUITING)
• AZ Maria Middelares — Ghent, Belgium (RECRUITING)
• Jessa Ziekenhuis — Hasselt, Belgium (RECRUITING)
• AZ Groeninge — Kortrijk, Belgium (ACTIVE_NOT_RECRUITING)
• UZ Leuven — Leuven, Belgium (RECRUITING)
• CHR de la Citadelle — Liège, Belgium (RECRUITING)
• CHU Liège — Liège, Belgium (ACTIVE_NOT_RECRUITING)
• AZ Delta — Roeselare, Belgium (RECRUITING)
• AZ Turnhout — Turnhout, Belgium (RECRUITING)
• Rijnstate — Arnhem, Netherlands (ACTIVE_NOT_RECRUITING)
• MUMC — Maastricht, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Jan Van Zundert

Conditions: Knee Osteoarthritis, Persistent Postsurgical Pain, Chronic Knee Pain, Osteoarthritis, Knee, Radiofrequency ablation