The aim of the COGENIUS trial is to investigate the effect of the two types of RF treatment on individuals experiencing chronic knee pain that is resistant to conservative treatments. For this purpose, the efficacy and cost-effectiveness of cooled…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
score (range 0-96) at 6 months post-intervention.
Secondary outcome
• 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 (including hospitalisations), knee interventions
and pain medication are actively monitored and captured during each
study contact. Three questions regarding medical specialist,
general practitioner visits, and other health care providers are added to
questionnaires package completed by patients at baseline, 3, 6, 9, 12 and 24
months.
• Productivity loss due to sickness assessed by the Work Productivity and
Activity Impairment (WPAI) questionnaire6 at baseline, 1, 3, 6, 9, 12 and 24
months.
Background summary
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. A total knee replacement is a viable
alternative for severe knee OA that does not respond to conservative therapy.
Unfortunately, up to 53% of patients who undergo a total knee replacement
develop persistent post-surgical pain (PPSP). There is momentarily no effective
therapy for PPSP.
A radiofrequency (RF) treatment applies high frequency current on the nerve
responsible for pain conduction, resulting in an interruption of the
transmission of pain. This can be applied to the nerves innervating the knee
joint * the superolateral, superomedial and inferomedial genicular nerves * and
could be an alternative, minimally invasive treatment for patients with knee OA
who fail conservative treatments and for patients with PPSP. Data from the
recent literature indicates that this treatment leads to a reduction of pain
intensity and could result in an improvement of knee function, of the
psychological state of the individual, and finally in an increase in
health-related quality of life. Furthermore, RF of the genicular nerves could
help avoid or delay a total knee replacement therefore potentially contributing
to cost reduction. Both cooled and conventional RF treatments are reported in
the literature to improve pain. The use of water to cool the RF electrodes
results in an increased lesion size by removing heat from adjacent tissue,
allowing power delivery to be increased. As a consequence, cooled RF could
result in a higher chance of success and longer duration of effect. Until now,
the studies performed on cooled RF are industry initiated and a direct
comparison between conventional, cooled and a sham procedure is lacking.
Study objective
The aim of the COGENIUS trial is to investigate the effect of the two types of
RF treatment on individuals experiencing chronic knee pain that is resistant to
conservative treatments. For this purpose, the efficacy and cost-effectiveness
of cooled and conventional RF will be compared to a sham procedure in patients
suffering from knee OA and PPSP after total knee replacement.
Study design
A prospective, multicentre, double blind, randomised controlled pragmatic trial
with three study groups with a 2:2:1 randomisation ratio
Intervention
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 three needles in the subcutaneous area of
the superolateral, superomedial and inferomedial genicular nerves with
injection of local anaesthetic which will mimic the intervention(s) mentioned
above.
Study burden and risks
Patients in the three intervention groups have the opportunity to benefit from
optimization of usual care and of positive treatment effects of the RF
intervention (pain relief, functional improvement, improved quality of life).
Potential side effects of the RF intervention are hematoma, infection,
temporary increase of pain, hyperesthesia, paraesthesia and neuralgia or
paralysis, superficial burns, damage to collateral nervous tissue or soft
tissue, failure of technique and allergy. Potential side effects of the sham
procedure are due to skin penetration (hematoma, infection) and allergy to the
local anaesthetic used. The additional risks associated with either
intervention options are expected to be very low, and we conclude that this
trial can be categorised as a *Low intervention* clinical trial for the
following reasons:
* The RF equipment device used for the study intervention has a CE Marketing
Authorisation in Europe.
* The RF equipment device is used in accordance with the indication as
mentioned in the European Marketing Authorisation.
* The additional (monitoring) study procedures do not deviate from routine
clinical practice in the Netherlands, apart from the use of more standardised
functional tests and questionnaires. These study procedures do not add
additional safety risks to the study subjects.
Synaps Park 1
Genk 3600
BE
Synaps Park 1
Genk 3600
BE
Listed location countries
Age
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
* 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 05407610 |
| CCMO | NL80503.068.22 |