Cocogen Trial: COoled Versus COnventional Radiofrequency Treatment of the GENicular Nerves for Chronic Knee Pain

NCT03865849 | Completed

• 1 other identifier: COCOGEN
• Study Type: interventional
• Target: 49
• Locations: 2 countries
• Sites: 3

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  at 1, 3, 6 and 12 months post intervention

Secondary Outcomes (9)

• Patient self-reported impression of change

  at 1, 3, 6 and 12 months post intervention

• The change in medication use

  at 1, 3, 6 and 12 months post intervention

• The duration of pain relief

  at 3, 6 and 12 months post intervention

• The change in physical function

  at baseline, 3, 6 and 12 months post intervention

• The change in health-related quality of life

  at baseline and at 1, 3, 6 and 12 months post intervention.

Study Arms (2)

Conventional radiofrequent treatment

ACTIVE COMPARATOR

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

Device: Conventional radiofrequent treatment

Cooled radiofrequent treatment

ACTIVE COMPARATOR

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).

Device: Cooled radiofrequent treatment

Interventions

Cooled radiofrequent treatment DEVICE

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.

Also known as: COOLIEF™ system

Cooled radiofrequent treatment

Conventional radiofrequent treatment DEVICE

In the conventional radiofrequency group a treatment of 80°C at the tip is applied during 90 seconds at each nerve.

Conventional radiofrequent treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• Rijnstate Hospital: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (3)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Pain Medicine Rijnstate

Arnhem, Netherlands

Location

Pain Medicine, Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (2)

• Belba A, Vanneste T, Kallewaard JW, van Kuijk SM, Gelissen M, Emans P, Bellemans J, Smeets K, Van Boxem K, Sommer M, Kimman M, Van Zundert J. Cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: 12-month and cost-effectiveness results from the multicenter COCOGEN trial. Reg Anesth Pain Med. 2025 Jan 7;50(1):36-45. doi: 10.1136/rapm-2023-105127.

  PMID: 38388017 DERIVED

• Vanneste T, Belba A, Kallewaard JW, van Kuijk SMJ, Gelissen M, Emans P, Bellemans J, Smeets K, Terwiel C, Van Boxem K, Sommer M, Van Zundert J. Comparison of cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: a multicenter non-inferiority randomized pilot trial (COCOGEN trial). Reg Anesth Pain Med. 2023 May;48(5):197-204. doi: 10.1136/rapm-2022-104054. Epub 2023 Jan 18.

  PMID: 36653065 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jan Van Zundert, MD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, multicentre, double blind, randomised controlled, non-inferiority, pilot study.

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 7, 2019
• Study Start: February 2, 2020
• Primary Completion: July 28, 2021
• Study Completion: October 28, 2021
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

BE (1); NL (2)