Status:
COMPLETED
Cocogen Trial: COoled Versus COnventional Radiofrequency Treatment of the GENicular Nerves for Chronic Knee Pain
Lead Sponsor:
Ziekenhuis Oost-Limburg
Collaborating Sponsors:
Rijnstate Hospital
Maastricht University Medical Center
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 mon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03865849
Start Date
February 2 2020
End Date
October 28 2021
Last Update
April 13 2023
Active Locations (3)
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1
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
2
Pain Medicine Rijnstate
Arnhem, Netherlands
3
Pain Medicine, Maastricht University Medical Centre
Maastricht, Netherlands