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 TRIA
- Conditions
- Chronic knee painostheoarthritis1002321310005944
- Registration Number
- NL-OMON56136
- Lead Sponsor
- Ziekenhuis Oost-Limburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
* 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).
* 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 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 54
diagnosed by an independent radiologist with experience in musculoskeletal
imaging on Rx or MRI.55 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 PPSP after TKA: Patients with PPSP after TKA need to
have had a negative orthopaedic work-up.
* Local or systemic infection (bacteraemia) at the time of inclusion.
* 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.
Unstable psychosocial disorder is defined as:
o any untreated psychiatric conditions
o any psychiatric condition where the treating medication is not stable the
last 3 months prior to inclusion
o patients currently treated by a psychiatrist and the psychiatrist could not
confirm that the psychosocial disorder is stable.
Patients treated by a general practitioner are considered to have a stable
condition.
* 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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)<br /><br>score (range 0-96) at 6 months post-intervention. </p><br>
- Secondary Outcome Measures
Name Time Method