Chronic knee pain ostheoarthritis Chronic knee pain - arthritis
Conditions
Interventions
There are two intervention groups: cooled and conventional radiofrequency (RF)
treatment of the superolateral, superomedial and inferomedial genicular nerves.
A sham procedure with placement of thre
Sponsors
Ziekenhuis Oost-Limburg
Eligibility
Age
18 Years to 99 Years
Inclusion 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). * 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, in case of OA patients, intra-articular 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.
Exclusion criteria
Exclusion criteria: * 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 e.g. fibromyalgia. * 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 genicular nerves of the index knee. Previous RF of the index knee other than of the genicular nerves is not an exclusion criterium. * Patients with therapy-resistant bilateral knee pain defined as patients who fulfil the inclusion criteria for pain in each knee i.e., patients who experience 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, in case of OA patients, intra-articular 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (range 0-96) at 6 months post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| • WOMAC score collected at baseline and 1-, 3-, 6-, 12- and 24-months post-intervention. • Pain intensity assessed by the mean numerical rating scale (NRS) (0-10) of the 4 days prior to each visit. Collection of NRS will happen at screening, baseline and 1-, 3-, 6-, 12- and 24-months post-intervention. • The proportion of patients with a pain reduction of at least 50% assessed by the NRS compared to baseline calculated at 1-, 3-, 6-, 12- and 24-months post-intervention*. • Health-related quality of life assessed by the EuroQoL-5D-5L (EQ-5D-5L) collected at baseline and 1-, 3-, 6-, 9-, 12- and 24-months post-intervention. • Physical functioning assessed by goniometry by using the CJOrtho app, *timed up and go* test and 6-min walk test collected at baseline and 1-, 3-, 6-, 12- and 24-months post-intervention. • Mental health status assessed by the Hospital Anxiety and Depression Scale (HADS) and Pain Catastrophizing Scale (PCS) collected at baseline and at 1-, 3-, 6-, 12- and 24-months post-intervention. • Patient Global Impression of Change (PGIC) collected at 1-, 3-, 6-, 12- and 24-months post-intervention. • Patient*s satisfaction assessed by 7-point Likert scale at 1-, 3-, 6-, 12- and 24-months post-intervention. • Medication use measured by: - the Medication Quantification Scale III (MQS III) collected at baseline and at 1-, 3-, 6-, 9-, 12- and 24-months post-intervention. - Opioid dependence at 1-, 3-, 6-, 9-, 12- and 24-months post-intervention visit. • The incidence of related adverse events. Active capture during each study contact to assess specific symptoms and adverse events related to RF intervention. • Health care resource utilisation, including adverse events, additional or re-interventions to the index knee, pain medication, visits to a range of medical specialists, general practitioner visits, and other health care providers, is assessed at baseline and 3, 6, 9, 12 and 24 months post-intervention. Adverse events (inclu | — |
Countries
Belgium, Netherlands
Contacts
Public ContactJ Van Zundert
Ziekenhuis Oost-Limburg
Outcome results
None listed