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New treatment option for Knee Osteoarthritis
Official title Comparison of Conventional and Cooled Radiofrequency of the Genicular Nerves in Patients With Chronic Knee Pain
ClinicalTrials.gov ID: NCT05407610
What this study is testing
- What it's testing
- Chronic knee pain remains a disabling disease despite current treatment strategies. There is an increase in the prevalence of osteoarthritis (OA) of the knee in the general population, presently affecting approximately 450,000 individuals in Belgium.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Unresponsive (meaning insufficient pain reduction or intolerance) to conventional treatments ongoing for at least 12 months prior to inclusion...
- Only for patients with Osteoarthritis (OA): Radiologic confirmation of knee osteoarthritis of grade 2 (mild), 3 (moderate) or 4 (severe) noted within...
You likely can't join if
- 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...
- Chronic widespread pain.
- Patients with unstable psychosocial disorder.
See the full eligibility 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...
- 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...
- 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...
- 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
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Belgium
- Brasschaat, Belgium
- Brussels, Belgium
- Genk, Belgium
- Ghent, Belgium
- Hasselt, Belgium
- Kortrijk, Belgium
- Leuven, Belgium
- Liège, Belgium
- Roeselare, Belgium
- Turnhout, Belgium
- Arnhem, Netherlands
- Maastricht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Belgium; Brasschaat, Belgium; Brussels, Belgium; Genk, Belgium; Ghent, Belgium; Hasselt, Belgium and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.