Knee OsteoarthritisCOGENIUSNCT05407610
Comparison of Conventional and Cooled Radiofrequency of the Genicular Nerves in Patients With Chronic Knee Pain
A study testing Conventional Radiofrequency ablation of the genicular nerves and Cooled Radiofrequency ablation of the genicular nerves in people with Knee Osteoarthritis and Persistent Postsurgical Pain, run by Ziekenhuis Oost-Limburg at 15 sites in 2 countries.
Trial 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, presently affecting approximately 450,000 individuals in Belgium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Persistent Postsurgical Pain, Chronic Knee Pain
- What is being tested?
- Conventional Radiofrequency ablation of the genicular nerves and Cooled Radiofrequency ablation of the genicular nerves
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 7 Jul 2022to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Belgium13 sites, 9 recruiting
- Recruiting
UZ Antwerpen
Antwerp, 2650
Babak Baheri
- Active, not recruiting
AZ Klina
Brasschaat, 2930
- Recruiting
ULB Erasme
Brussels, 1070
Turgay Tuna
- Active, not recruiting
UCL Saint-Luc
Brussels, 1200
- Recruiting
Ziekenhuis Oost-Limburg AV
Genk, 3600
Thibaut Vanneste
- Recruiting
AZ Maria Middelares
Ghent
Pieter Vander Cruysse
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
Michiel Brands
- Active, not recruiting
AZ Groeninge
Kortrijk, 8500
- Recruiting
UZ Leuven
Leuven, 3000
Bart Morlion
- Recruiting
CHR de la Citadelle
Liège, 4000
Caroline Dresse
- Active, not recruiting
CHU Liège
Liège, 4000
- Recruiting
AZ Delta
Roeselare, 8800
Karel Hanssens
- Recruiting
AZ Turnhout
Turnhout, 2300
Christophe Lebrun
Netherlands2 sites, 1 recruiting
- Active, not recruiting
Rijnstate
Arnhem, 6815 AD
- Recruiting
MUMC
Maastricht, 6229 HX
Micha Sommer
About this study
Official title: 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
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. 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 currently 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.
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.
Read the detailed description
In this three-arm, pragmatic, prospective, multicentre, double blind, randomised sham-controlled trial of approximately 4 years duration, 400 patients with chronic moderate to severe anterior knee pain (>12 months) refractory to conventional treatments will be included. Two groups of chronic knee pain patients will be enrolled depending on the aetiology of knee pain: OA and PPSP. Each patient will undergo a run-in period of 1 to 3 months depending on the previous treatments of the patient. A run-in period is added to the trial to guarantee that conservative treatment is performed in an optimal way before randomisation. In each group (osteoarthritis and persistent post-surgical pain), non-responders to the run-in period will be randomly allocated to a conventional RF intervention of the genicular nerves, a cooled RF intervention of the genicular nerves or a sham procedure in a 2:2:1 ratio. The patients will be followed up for a period of 2 years.
- Being tested
- Conventional Radiofrequency ablation of the genicular nerves, Cooled Radiofrequency ablation of the genicular nerves, Sham procedure
- Keywords
- Osteoarthritis, Persistent Postsurgical Pain, Knee, Radiofrequency ablation
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Radiofrequency ablation of the genicular nervesProcedure or surgery
Also called Conventional Radiofrequency ablation
Conventional Radiofrequency treatment of the genicular nerves of the knee blocks the transmission of painful stimuli from the sensory genicular nerves of the knee to the central nervous system by means of a thermal lesion created using RF current.
Cooled Radiofrequency ablation of the genicular nervesProcedure or surgery
Also called Cooled Radiofrequency ablation
Cooled RF treatment causes a larger lesion size compared to conventional RF by means of internal cooling of the probe.
Sham procedureProcedure or surgery
Sham procedure with placing of needles subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Radiofrequency of the genicular nerves | Active comparator | In the conventional radiofrequency group a intervention of 80°C at the tip is applied during 90 seconds at each nerve (superolateral, superomedial and inferomedial genicular nerves). The probe stays in place for 150 seconds at each nerve so that the time needed for each procedure is similar. Receives: Procedure: Conventional Radiofrequency ablation of the genicular nerves |
| Cooled Radiofrequency of the genicular nerves | Active comparator | In the cooled radiofrequency group a intervention of 60°C measured at the tip and on average 80°C in the targeted tissue is applied for 150 seconds using the Cooled RF system at each nerve (superolateral, superomedial and inferomedial genicular nerves). Receives: Procedure: Cooled Radiofrequency ablation of the genicular nerves |
| Sham procedure | Sham comparator | In the sham group a 18 gauge introducer and probe will be placed but no RF intervention will be applied. The generator will be turned on without connection to the probe for 150 seconds and the sound of the generator will be mimicked with a recording. The position of the needle will not be checked by fluoroscopy; however, the intervention team will position the fluoroscopy arm and mention the acquisition of the fluoroscopic image to the patient. This way no unnecessary radiation is used. Receives: Procedure: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6 months post-intervention
The primary endpoint is the WOMAC score (range 0-96) at 6 months post-intervention.
The WOMAC score is derived from a self-administered osteoarthritis-specific validated questionnaire on pain, stiffness, and physical functioning of the knee joint.The lower the score, the lower the osteoarthritis-specific symptoms are.
Measured: 6 months post-intervention.
Secondary outcomes (16)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.
The WOMAC score (range 0-96) is derived from a self-administered osteoarthritis-specific validated questionnaire on pain, stiffness, and physical functioning of the knee joint.The lower the score, the lower the osteoarthritis-specific symptoms are.
Measured: 1-, 3-, 6-, 12- and 24-months post-intervention.
Pain Intentisty
Pain intensity expressed by the Numerical Rating Scale (NRS) (range 0-10). The NRS score at each visit will be calculated as the mean score of the 4 days prior to each visit.The lower the score, the least pain the patient experiences.
Measured: 1-, 3-, 6-, 12- and 24-months post-intervention.
The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS)
The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS) (0-10). The NRS score at each visit will be calculated as the mean score of the 4 days prior to each visit.The lower the score, the least pain the patient experiences.
Measured: 1-, 3-, 6-, 12- and 24-months post-intervention.
Health-related quality of life
Health-related quality of life assessed by the EuroQoL-5D-5L (EQ-5D-5L). The questionnaire consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a visual assessment scale. Responses to the 5 items (one for each dimension) result in a patient's health state that can be transformed into a utility score ranging between 0 (death) and 1 (full health), representing the quality of life of the health state. For the visual assessment scale section, the patient indicates their impression of health on the visual scale. The scale has the following distribution: 0 indicating "worse possible health" and 100 indicating "best possible health".
Measured: 1-, 3-, 6-, 9-, 12- and 24-months post-intervention.
Goniometry
Goniometry (maximal knee flexion and extension expressed in degrees) is assessed using the CJOrtho app. The degrees range from 0 to 180 degrees.
Measured: 1-, 3-, 6-, 12- and 24-months post-intervention.
'Timed up and Go' test
The 'Timed up and Go' test assesses the physical functioning of the patient.
Measured: 1-, 3-, 6-, 12- and 24-months post-intervention.
The 6-minute walk test
The 6-minute walk test assesses the physical functioning of the patient. The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 1-, 3-, 6-, 12- and 24-months post-intervention.
The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) assesses and detect anxiety and depression in patients with physical health problems. The questionnaire consists of 14 items: 7 items to measure anxiety and 7 items to measure depression.
Measured: 1-, 3-, 6-, 12- and 24-months post- intervention.
The Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) assesses the mental health of the patient.The 13 item questionnaire consists of 3 subscales (magnification, rumination and helplessness) and asks patients to reflect on past painful experiences and to indicate the degree on which they experiences each of 13 thoughts of feelings on a 5- point scale (0 not at all and 4 all the time).
Measured: 1-, 3-, 6-, 12- and 24-months post- intervention.
Patient Global Impression of Change (PGIC)
Patients' Patient's Global Impression of Change (PGIC) scale is a self-reported measure that reflects the patient's belief about the treatment efficacy. The patient is asked to rate the efficacy of the treatment on a scale of 1 (much better) to 7 (much worse).
Measured: 1-, 3-, 6-, 12- and 24-months post- intervention.
Patient's satisfaction
Patient's satisfaction assessed by 7-point Likert scale with 0 representing total dissatisfaction and 10 representing maximal satisfaction.
Measured: 1-, 3-, 6-, 12- and 24-months post- intervention.
Medication use
Medication use measured by Medication Quantification Scale III (MQS III).It computes a single numeric value for a patient's pain medication profile. This number is used to track pain levels through a treatment course or research study.
Measured: 1-, 3-, 6-, 9-, 12- and 24-months post- intervention.
Opioid dependence
The patient is strong opioid dependent if the patient takes an opioid analgesic with the exception of analgesics with tramadol or codeine.
Measured: 1-, 3-, 6-, 9-, 12- and 24-months post- intervention.
Incidence of related adverse events
The incidence of related adverse events. Active capture during each study contact to assess specific symptoms and adverse events relevant to chronic knee pain or RF intervention.
Measured: Follow-up until 24-months post- intervention.
Health care resource utilisation
The health care resource use questions are created for the COGENIUS study to collect information regarding the visits to a medical specialist (doctor or nurse) or general practitioner as a result of knee pain.
Measured: Follow-up until 24-months post- intervention.
Productivity loss due to sickness
Productivity loss due to sickness assessed by the Work Productivity and Activity Impairment (WPAI). Productivity loss due to sickness refers to output loss resulting from work absence and/or reduced labour input due to sickness. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.
Measured: Follow-up until 24-months post- intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start7 Jul 2022
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, pragmatic, prospective, multicentre, double blind, randomised sham-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Belgium Health Care Knowledge Centre, Klinische Epidemiologie en Medical Technology Assessment
- Responsible party
- Principal investigator, Jan Van Zundert, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407610
- Sponsor's protocol ID
- COGENIUS
- Other IDs
- Z-2021109, KCE20-1255
- Acronym
- COGENIUS
- Status last verified
- May 2023
- First submitted
- 1 Jun 2022
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researcher will need to contact ctu@zol.be in order to request the 'Data Sharing Application' form. Users will need to complete an application form, 'Request for Data Sharing'. The application will be reviewed by the Trial Steering Committee with regard to feasibility and confidentiality. When the application is approved by the Trial Steering Committee, the applicant will be requested to sign a 'Data Use Agreement'. This Data Use Agreement shall be countersigned by ZOL as Sponsor and the CI of the COGENIUS study.
Publications
Vanneste T, Belba A, van Kuijk S, Kimman M, Bellemans J, Bonhomme V, Sommer M, Emans P, Vankrunkelsven P, Tartaglia K, Van Zundert J. Comparison of conventional and cooled radiofrequency treatment of the genicular nerves versus sham procedure for patients with chronic knee pain: protocol for a multicentre, double-blind, randomised controlled trial (COGENIUS). BMJ Open. 2023 Aug 2;13(8):e073949. doi: 10.1136/bmjopen-2023-073949.
PubMed 37532482
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05407610
- Acronym / sponsor ID
- COGENIUS / COGENIUS
- Keywords
- Osteoarthritis, Persistent Postsurgical Pain, Knee, Radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Belgium Health Care Knowledge Centre, Klinische Epidemiologie en Medical Technology Assessment
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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 currently 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.
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.
Detailed description
In this three-arm, pragmatic, prospective, multicentre, double blind, randomised sham-controlled trial of approximately 4 years duration, 400 patients with chronic moderate to severe anterior knee pain (>12 months) refractory to conventional treatments will be included. Two groups of chronic knee pain patients will be enrolled depending on the aetiology of knee pain: OA and PPSP. Each patient will undergo a run-in period of 1 to 3 months depending on the previous treatments of the patient. A run-in period is added to the trial to guarantee that conservative treatment is performed in an optimal way before randomisation. In each group (osteoarthritis and persistent post-surgical pain), non-responders to the run-in period will be randomly allocated to a conventional RF intervention of the genicular nerves, a cooled RF intervention of the genicular nerves or a sham procedure in a 2:2:1 ratio. The patients will be followed up for a period of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, pragmatic, prospective, multicentre, double blind, randomised sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Conventional Radiofrequency of the genicular nerves | Active comparator | Procedure: Conventional Radiofrequency ablation of the genicular nervesIn the conventional radiofrequency group a intervention of 80°C at the tip is applied during 90 seconds at each nerve (superolateral, superomedial and inferomedial genicular nerves). The probe stays in place for 150 seconds at each nerve so that the time needed for each procedure is similar. |
| Cooled Radiofrequency of the genicular nerves | Active comparator | Procedure: Cooled Radiofrequency ablation of the genicular nervesIn the cooled radiofrequency group a intervention of 60°C measured at the tip and on average 80°C in the targeted tissue is applied for 150 seconds using the Cooled RF system at each nerve (superolateral, superomedial and inferomedial genicular nerves). |
| Sham procedure | Sham comparator | Procedure: Sham procedureIn the sham group a 18 gauge introducer and probe will be placed but no RF intervention will be applied. The generator will be turned on without connection to the probe for 150 seconds and the sound of the generator will be mimicked with a recording. The position of the needle will not be checked by fluoroscopy; however, the intervention team will position the fluoroscopy arm and mention the acquisition of the fluoroscopic image to the patient. This way no unnecessary radiation is used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Radiofrequency ablation of the genicular nervesAlso: Conventional Radiofrequency ablationConventional Radiofrequency treatment of the genicular nerves of the knee blocks the transmission of painful stimuli from the sensory genicular nerves of the knee to the central nervous system by means of a thermal lesion created using RF current. | Procedure or surgery | Conventional Radiofrequency of the genicular nerves |
| Cooled Radiofrequency ablation of the genicular nervesAlso: Cooled Radiofrequency ablationCooled RF treatment causes a larger lesion size compared to conventional RF by means of internal cooling of the probe. | Procedure or surgery | Cooled Radiofrequency of the genicular nerves |
| Sham procedureSham procedure with placing of needles subcutaneously. | Procedure or surgery | Sham procedure |
Primary outcome
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6 months post-intervention
Time frame: 6 months post-intervention.
The primary endpoint is the WOMAC score (range 0-96) at 6 months post-intervention. The WOMAC score is derived from a self-administered osteoarthritis-specific validated questionnaire on pain, stiffness, and physical functioning of the knee joint.The lower the score, the lower the osteoarthritis-specific symptoms are.
16 secondary outcomes
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.
Time frame: 1-, 3-, 6-, 12- and 24-months post-intervention.
Pain Intentisty
Time frame: 1-, 3-, 6-, 12- and 24-months post-intervention.
The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS)
Time frame: 1-, 3-, 6-, 12- and 24-months post-intervention.
Health-related quality of life
Time frame: 1-, 3-, 6-, 9-, 12- and 24-months post-intervention.
Goniometry
Time frame: 1-, 3-, 6-, 12- and 24-months post-intervention.
'Timed up and Go' test
Time frame: 1-, 3-, 6-, 12- and 24-months post-intervention.
The 6-minute walk test
Time frame: 1-, 3-, 6-, 12- and 24-months post-intervention.
The Hospital Anxiety and Depression Scale (HADS)
Time frame: 1-, 3-, 6-, 12- and 24-months post- intervention.
The Pain Catastrophizing Scale (PCS)
Time frame: 1-, 3-, 6-, 12- and 24-months post- intervention.
Patient Global Impression of Change (PGIC)
Time frame: 1-, 3-, 6-, 12- and 24-months post- intervention.
Patient's satisfaction
Time frame: 1-, 3-, 6-, 12- and 24-months post- intervention.
Medication use
Time frame: 1-, 3-, 6-, 9-, 12- and 24-months post- intervention.
Opioid dependence
Time frame: 1-, 3-, 6-, 9-, 12- and 24-months post- intervention.
Incidence of related adverse events
Time frame: Follow-up until 24-months post- intervention.
Health care resource utilisation
Time frame: Follow-up until 24-months post- intervention.
Productivity loss due to sickness
Time frame: Follow-up until 24-months post- intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 37532482Vanneste T, Belba A, van Kuijk S, Kimman M, Bellemans J, Bonhomme V, Sommer M, Emans P, Vankrunkelsven P, Tartaglia K, Van Zundert J. Comparison of conventional and cooled radiofrequency treatment of the genicular nerves versus sham procedure for patients with chronic knee pain: protocol for a multicentre, double-blind, randomised controlled trial (COGENIUS). BMJ Open. 2023 Aug 2;13(8):e073949. doi: 10.1136/bmjopen-2023-073949.
- Individual participant dataSharing planned: Yes. Researcher will need to contact ctu@zol.be in order to request the 'Data Sharing Application' form. Users will need to complete an application form, 'Request for Data Sharing'. The application will be reviewed by the Trial Steering Committee with regard to feasibility and confidentiality. When the application is approved by the Trial Steering Committee, the applicant will be requested to sign a 'Data Use Agreement'. This Data Use Agreement shall be countersigned by ZOL as Sponsor and the CI of the COGENIUS study.
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Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Radiofrequency ablation of the genicular nerves and Cooled Radiofrequency ablation of the genicular nerves in people with Knee Osteoarthritis and Persistent Postsurgical Pain, run by Ziekenhuis Oost-Limburg at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Van Zundert (+32 (0)89 32.52.54, cogenius@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6 months post-intervention (time frame: 6 months post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05407610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.