Back to resultsCocogen Trial: COoled Versus COnventional Radiofrequency Treatment of the GENicular Nerves for Chronic Knee Pain
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cooled radiofrequent treatment
Conventional radiofrequent treatment
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
- Chronic anterior knee pain (> 12 months) with an NRS > 4 on most or all days for the index knee either constantly or with motion.
- Unresponsive to conventional treatments continued during 12 months including physiotherapy, oral analgesics or intra-articular infiltrations.
- Radiologic confirmation of arthritis of OA grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee according the Kellgren Lawrence criteria (27) diagnosed by an independent radiologist with experience in musculoskeletal imaging or patients with total knee arthroplasty of the index knee with a negative orthopaedic workout.
- Other therapies (including surgical interventions) for pain in the index knee are allowed for the period of the study follow up as long as they are documented. This is necessary to correctly estimate the costs in the cost effectiveness analyses. Allowing patients to receive additional treatments will also improve the protocol compliance.
- Agree to provide informed consent and to comply with the requirements of this protocol for the full duration of the study
Exclusion Criteria:
- Patient refusal to comply to protocol procedures or schedule
- 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
- Body mass index (BMI) > 40 kg/m2
- Pregnant, nursing or planning to become pregnant Chronic widespread pain before the treatment
- Patients with psychosocial dysfunction will be referred for further psychological follow up prior to possible inclusion
- Allergies to products used during the procedure
- 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 defibrillator, neuromodulator or other electrical devices
- Radicular pain in index leg
- Patient received previous conventional or cooled radiofrequency of the index knee
Sites / Locations
- Ziekenhuis Oost-Limburg
- Pain Medicine Rijnstate
- Pain Medicine, Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional radiofrequent treatment
Cooled radiofrequent treatment
Arm Description
The patient is placed in a supine position on a fluoroscopy table with the index knee flexed 10-15°. The procedure is performed with a 100 mm long, 18 G straight RF cannula/introducer (Halyard) with a probe/electrode with a 10 mm active tip
The procedure is performed with a 100 mm long, 18 G straight RF cannula/introducer (Halyard) with a probe/electrode with a 100 mm long, 17 G RF cannula/introducer with an 18 G cooled probe/electrode with a 4 mm active tip (Halyard/Coolief).
Outcomes
Primary Outcome Measures
The change in pain intensity
NRS is a unidimensional, subjective measurement of pain intensity, expressed by the patient as a number between 0 and 10. It is a 11 point scale in which 0 equals no pain and 10 maximal pain.
Secondary Outcome Measures
Patient self-reported impression of change
Patient self-reported impression of change, measured by the Patient's Global Impression of Change (PGIC). The impression of change is measured using a 7 point likert scale ranging from "very much worse (7)" to "very much improved (1)."
The change in medication use
The change in medication use, measured by the change in Medication Quantification Scale III (MQS III). The MQS is designed as a methodology of quantifying different drug regimens in 1992 and updated in 1998 (MQS II) and 2003 (MQS III) using detriment weights determined by surveying physician members of the American Pain Society
The duration of pain relief
This is defined as the time interval in which a NRS reduction of more than 50% is obtained or in which the pain is still acceptable without the usage of other additional therapies (increase in MQS 3 score of more than 50%, intra-articular infiltration, operation)
The change in physical function
This will be measured by the change in the Oxford Knee Score (OKS). The OKS is a patient-reported measure assessing pain intensity and physical function. The list consists of 12 items scored from 1 to 5, with 0 representing normal function/ least symptoms.
The change in health-related quality of life
This measured by the change in EQ-5D-5L,intervention.The EQ-5D-5L is a patient-reported generic measure of HRQoL comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. 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.
Hospital Anxiety and Depression Scale (HADS)
HADS is developed to 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
Pain Catastrophizing Scale (PCS)
The PCS is often used in clinical settings to measure catastrophic thinking related to pain. 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).
Goniometry knee
Knee flexion and extension is assessed using a phone app meant to simulate a goniometer. The goniometry results are expressed in degrees.
Timed up and go test
In the timed up and go test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The results are expressed in minutes or seconds.
Full Information
NCT ID
NCT03865849
First Posted
March 4, 2019
Last Updated
April 12, 2023
Sponsor
Ziekenhuis Oost-Limburg
Collaborators
Rijnstate Hospital, Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03865849
Brief Title
Cocogen Trial: COoled Versus COnventional Radiofrequency Treatment of the GENicular Nerves for Chronic Knee Pain
Official Title
Comparison of Cooled Versus Conventional Radiofrequency Treatment of the Genicular Nerves for Chronic Knee Pain: a Multicentre Randomised Controlled Non-inferiority Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2020 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
October 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg
Collaborators
Rijnstate Hospital, Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Knee osteoarthritis is a progressive degenerative process that affects joint cartilage and the subchondral bone. Approximately 10% to 30% of all osteoarthritis patients suffer from disabling symptoms such as pain, stiffness and loss of function leading to psychological and sleeping disorders and a diminished quality of life. When conservative treatment fails to treat the symptoms, a total knee arthroplasty can be performed. However, this procedure is not suitable for all patients. For these specific groups of patients a radiofrequent treatment of the genicular nerves might be an alternative treatment option. Multiple researchers investigated the effect of conventional and later also, cooled radiofrequent treatment of the genicular nerves, with promising results for both techniques. However, the techniques have never been compared in a randomised controlled trial. This study is designed to assess the feasibility of conducting a large RCT comparing pain relief and costs after a conventional radiofrequency treatment of the genicular nerves (superomedial, superolateral and inferomedial) versus a cooled radiofrequency treatment.
Detailed Description
This pilot study is designed as a prospective, multicentre, double blind, randomised controlled non-inferiority trial. The total follow up time is 6 months with follow up assessments at 1, 3 and 6 months post intervention. It is estimated that the total duration of data collection will cover 1 year. Adult patients (> 18 years) with chronic, moderate to severe knee pain (NRS>4) due to osteoarthritis, radiological diagnosed to be graded 2-4 according to the Kellgren-Lawrence criteria or with persistent postoperative moderate to severe knee pain (NRS>4) after total knee arthroplasty can be included in the study.
Patients will be randomly selected for treatment with conventional radiofrequent treatment or cooled radiofrequent treatment of the SL, SM and IL genicular nerves. In total, three hospitals participate in this study: Ziekenhuis Oost-Limburg (Belgium), Maastricht UMC+ (Netherlands) and Rijnstate (Netherlands).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multicentre, double blind, randomised controlled, non-inferiority, pilot study.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional radiofrequent treatment
Arm Type
Active Comparator
Arm Description
The patient is placed in a supine position on a fluoroscopy table with the index knee flexed 10-15°. The procedure is performed with a 100 mm long, 18 G straight RF cannula/introducer (Halyard) with a probe/electrode with a 10 mm active tip
Arm Title
Cooled radiofrequent treatment
Arm Type
Active Comparator
Arm Description
The procedure is performed with a 100 mm long, 18 G straight RF cannula/introducer (Halyard) with a probe/electrode with a 100 mm long, 17 G RF cannula/introducer with an 18 G cooled probe/electrode with a 4 mm active tip (Halyard/Coolief).
Intervention Type
Device
Intervention Name(s)
Cooled radiofrequent treatment
Other Intervention Name(s)
COOLIEF™ system
Intervention Description
In the cooled radiofrequency group a treatment of 60°C measured at the tip and on average 80°C in the targeted tissue is applied during 150 seconds using the Coolief system.
Intervention Type
Device
Intervention Name(s)
Conventional radiofrequent treatment
Intervention Description
In the conventional radiofrequency group a treatment of 80°C at the tip is applied during 90 seconds at each nerve.
Primary Outcome Measure Information:
Title
The change in pain intensity
Description
NRS is a unidimensional, subjective measurement of pain intensity, expressed by the patient as a number between 0 and 10. It is a 11 point scale in which 0 equals no pain and 10 maximal pain.
Time Frame
at 1, 3, 6 and 12 months post intervention
Secondary Outcome Measure Information:
Title
Patient self-reported impression of change
Description
Patient self-reported impression of change, measured by the Patient's Global Impression of Change (PGIC). The impression of change is measured using a 7 point likert scale ranging from "very much worse (7)" to "very much improved (1)."
Time Frame
at 1, 3, 6 and 12 months post intervention
Title
The change in medication use
Description
The change in medication use, measured by the change in Medication Quantification Scale III (MQS III). The MQS is designed as a methodology of quantifying different drug regimens in 1992 and updated in 1998 (MQS II) and 2003 (MQS III) using detriment weights determined by surveying physician members of the American Pain Society
Time Frame
at 1, 3, 6 and 12 months post intervention
Title
The duration of pain relief
Description
This is defined as the time interval in which a NRS reduction of more than 50% is obtained or in which the pain is still acceptable without the usage of other additional therapies (increase in MQS 3 score of more than 50%, intra-articular infiltration, operation)
Time Frame
at 3, 6 and 12 months post intervention
Title
The change in physical function
Description
This will be measured by the change in the Oxford Knee Score (OKS). The OKS is a patient-reported measure assessing pain intensity and physical function. The list consists of 12 items scored from 1 to 5, with 0 representing normal function/ least symptoms.
Time Frame
at baseline, 3, 6 and 12 months post intervention
Title
The change in health-related quality of life
Description
This measured by the change in EQ-5D-5L,intervention.The EQ-5D-5L is a patient-reported generic measure of HRQoL comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. 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.
Time Frame
at baseline and at 1, 3, 6 and 12 months post intervention.
Title
Hospital Anxiety and Depression Scale (HADS)
Description
HADS is developed to 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
Time Frame
at baseline and at 1, 3, 6 and 12 months post intervention.
Title
Pain Catastrophizing Scale (PCS)
Description
The PCS is often used in clinical settings to measure catastrophic thinking related to pain. 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).
Time Frame
at baseline and at 1, 3 and 6 months post intervention.
Title
Goniometry knee
Description
Knee flexion and extension is assessed using a phone app meant to simulate a goniometer. The goniometry results are expressed in degrees.
Time Frame
at baseline and at 3 and 6 months post intervention.
Title
Timed up and go test
Description
In the timed up and go test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The results are expressed in minutes or seconds.
Time Frame
at baseline and at 3 and 6 months post intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
Chronic anterior knee pain (> 12 months) with an NRS > 4 on most or all days for the index knee either constantly or with motion.
Unresponsive to conventional treatments continued during 12 months including physiotherapy, oral analgesics or intra-articular infiltrations.
Radiologic confirmation of arthritis of OA grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee according the Kellgren Lawrence criteria (27) diagnosed by an independent radiologist with experience in musculoskeletal imaging or patients with total knee arthroplasty of the index knee with a negative orthopaedic workout.
Other therapies (including surgical interventions) for pain in the index knee are allowed for the period of the study follow up as long as they are documented. This is necessary to correctly estimate the costs in the cost effectiveness analyses. Allowing patients to receive additional treatments will also improve the protocol compliance.
Agree to provide informed consent and to comply with the requirements of this protocol for the full duration of the study
Exclusion Criteria:
Patient refusal to comply to protocol procedures or schedule
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
Body mass index (BMI) > 40 kg/m2
Pregnant, nursing or planning to become pregnant Chronic widespread pain before the treatment
Patients with psychosocial dysfunction will be referred for further psychological follow up prior to possible inclusion
Allergies to products used during the procedure
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 defibrillator, neuromodulator or other electrical devices
Radicular pain in index leg
Patient received previous conventional or cooled radiofrequency of the index knee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Van Zundert, MD
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Pain Medicine Rijnstate
City
Arnhem
Country
Netherlands
Facility Name
Pain Medicine, Maastricht University Medical Centre
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Cocogen Trial: COoled Versus COnventional Radiofrequency Treatment of the GENicular Nerves for Chronic Knee Pain
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