Comparison of cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: a multicentre randomised controlled non-inferiority pilot trial

Completed

• Conditions: knee pain; osteoarthritis; 10023213; 10005944

• Registration Number: NL-OMON55198
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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 on Rx or MRI 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
- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> The primary study outcome parameter is the proportion of patients with a pain<br /><br>intensity reduction of at least 50% at 3 months post intervention compared to<br /><br>baseline. Pain intensity is measured by a Numeric Rating Scale. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters include physical functioning, health-related quality of<br /><br>life, emotional outcome, patient satisfaction, side effects, duration effect,<br /><br>medication use, costs and cost effectiveness. Inclusion rates per patient<br /><br>subgroup (osteoarthritis and post total knee arthroplasty) and per hospital<br /><br>will be monitored as well.</p><br>