CompletedNot Applicable

Management of Knee Pain by Cooled Radiofrequency in Classical Anatomical Targets and Revised Targets

Brazil10 participantsStarted 2022-09-01

Plain-language summary

Osteoarthritis (OA) is a chronic and progressive disease that results from characteristic pathological changes in the tissues of the entire joint, resulting in failure in the component parts. OA is one of the most common causes of disability in adults due to pain and altered joint function, impacting patients' quality of life. Treatment is based on decreasing pain and improving function, involving non-pharmacological, pharmacological, and surgical management. First-line treatment involves non-pharmacological and pharmacological measures. When OA is very advanced, total joint replacement surgery is recommended. However, for patients refractory to conservative treatment and unwilling or unable to undergo arthroplasty, few options remain. Recently, several studies involving minimally invasive procedures are being recommended. Among them is the cooled radiofrequency technique, causing neurotomy by thermal activity, thus reducing the patient's perception of pain. The classical therapeutic target for this technique are the genicular nerves of the knee. However, more recent studies have shown that these classical targets do not provide complete pain relief and have suggested new therapeutic targets, comprising besides the genicular nerves, the recurrent peroneal nerve and the infra-patellar branch of the saphenous nerve. In order to validate these revised targets, new studies need to be done. Therefore, the aim of the present study is to evaluate the efficacy of the cooled radiofrequency procedure using classical and revised targets, and to compare pain intensity, knee function, quality of life, analgesic consumption and adverse effects of both techniques. Key words: Osteoarthritis of the knee. Sensory nerve denervation. Classical targets. Revised targets.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients of both genders aged 40 years or older; * Patients diagnosed with knee OA through X-rays and MRI (Alhback classification 2 or 3); * Patients with chronic knee pain for more than 3 months at the time of inclusion; * Patients with moderate to severe knee pain (score of 5 or more on the visual analog scale) * Patients who are literate, can read and write, and have a good understanding of written and verbal language. Exclusion Criteria: * Patients younger than 40 years old, even if diagnosed with knee OA; * Patients not diagnosed through imaging tests with OA; * Patients who have undergone previous knee surgery in the last 3 months before inclusion; * Patients who have received intra-articular corticosteroid injection in the last 3 months before inclusion; * Patients with uncontrolled neurological or psychiatric disease; * Patients with uncontrolled diabetes; * Pregnant patients; * Cancer diagnosed patients; * Patients with lumbar radiculopathy; * Patients on continuous anticoagulant therapy; * Patients who are not literate, can not read and write, and have not a good understanding of written and verbal language.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Analyze the efficacy of cooled radiofrequency in patients with chronic knee osteoarthritis pain.

Timeframe: 7 months

Trial details

NCT IDNCT05363241

SponsorUniversidade Federal de Alfenas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Osteoarthritis, Knee trials