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Completed

NCT Number: NCT03628482

Pulsed Radiofrequency to Relieve Knee Pain

Knee osteoarthritis is a leading cause of chronic pain, disability, and decreased quality of life. Lesioning of genicular nerves by continuous radiofrequency treatment proved to be effective in relieving pain and disability caused by osteoarthritis of the knee. In contrast to continuous radiofrequency lesioning, pulsed radiofrequency treatment offers pain control with no or only minimal histological lesions. As a non-destructive alternative to continuous radiofrequency ablation, pulsed radiofrequency treatment may have inherent appeal because it may mitigate concerns regarding complications associated with the ablation of nerves. However, studies comparing the ability of the continuous and the pulsed modalities of radiofrequency treatment to relieve pain and incapacity due to osteoarthritis of the knee are lacking. Therefore, it was the aim of the investigators of current study to compare efficacy of continuous and pulsed radiofrequency treatments of genicular nerves to alleviate pain and disability in patients with advanced osteoarthritis of the knee.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luc Vanlinthout

Antwerp, 2018, Belgium

About this study

Following approval of the Regional Research Ethics Committee written informed consent was obtained from all patients. Current randomized controlled trial included patients with grade 3-4 gonarthritis suffering from intractable knee pain, scoring ≥5 on the Visual Analog Scale (VAS) during >6 months. Therapy was based on ultrasound guided radiofrequency treatment of the superior medial, superior lateral and inferior medial genicular nerves. VAS and Western Ontario and MacMaster Universities Osteoarthrosis (WOMAC) scores were assessed before therapy and at 1, 6 and 12 months following intervention. Eligible patients were randomized in two treatment groups according to the modality of radiofrequency current to which targeted genicular nerves had to be exposed, i.e, the pulsed and the continuous radiofrequency groups. Both two way repeated measures analysis of variance and generalized estimating equations were used to determine whether the VAS and WOMAC scores obtained with either the continuous or the pulsed radiofrequency modalities at each of the 4 times of assessment, i.e. at pre-treatment control and at 1, 6 and 12 months after the intervention, were different.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible patients suffered from chronic pain (during>6months) of moderate to severe intensity (scoring ≥5 on a 0- to 10-point continuous visual analog scale [VAS] ranging from none [0] to an extreme amount of pain [10]) due to advanced osteoarthritis of the knee (grades 3-4 according to the Kellgren-Lawrence classification. The pain proved to be resistant to conservative treatments including physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids. In this study, genicular nerve ablation was applied as an alternative analgesic approach for those who refused knee arthroplasty; were judged by their surgeons as being inappropriate for surgical treatment, for example, because of cardiovascular or other comorbidities; or who had to be managed for persistent pain and stiffness after total knee arthroplasty.

Exclusion criteria

  • The exclusion criteria included knee-pain related disorders that might benefit from other interventions, for example, patellofemoral disorders, meniscal injuries, ligamentous laxity, and so on, acute knee pain associated with radicular neuropathy or intermittent claudication, connective tissue diseases, serious neurologic or psychiatric disorders, mental deterioration impeding adequate communication or collaboration, anticoagulant medications, pacemakers, prior electroacupuncture treatment, and injection with steroids or hyaluronic acids during the previous 6 months.

Treatment and study plan

CRF

Procedure

For continuous radiofrequency ablation the electrode tip temperature was raised to 80°C during 90 s.

Other names: Continuous radiofrequency treatment

PRF

Procedure

The procedure for PRF is almost identical to that applied for CRF, except that the current is typically carried out in 20 ms pulses every 0.5 s at a temperature that does not exceed 42 °C during 360 s.

Other names: Pulsed radiofrequency treatment

Primary outcomes

  1. Visual analogue scale (VAS) score

    Time frame: VAS score at 12 months following the radiofrequency treatment.

    The pain VAS is a unidimensional measure of pain intensity (1), rated on a continuous scale which is 10 centimeters in length, and anchored by 2 verbal descriptors, one for each symptom extreme , " no pain " and " worst imaginable pain ". Our null hypothesis was that no significant difference would exist in VAS scores between the continuous and the pulsed radiofrequency groups at 12 months following the intervention.

Secondary outcomes

  1. The Western Ontario and Mac Master Universities Osteoarthritis Index (WOMAC)

    Time frame: WOMAC score at 12 months following the radiofrequency treatment.

    The Western Ontario and Mac Master Universities Osteoarthritis Index (WOMAC) is a standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. Our null hypothesis was that no significant difference would exist in the WOMAC scores between the continuous and the pulsed radiofrequency groups at 12 months following the intervention.

  2. Adverse events

    Time frame: adverse effects at 12 months following the radiofrequency treatment.

    Adverse effects including abnormal proprioception, numbness, paresthesia, neuralgia, and motor weakness were recorded.

Sponsors and collaborators

Lead sponsor

Gasthuis Zusters Antwerpen

Other

Collaborators

  • Hospital General de Jerez de la Frontera
  • ZOL

Registry information

Official study title

A Randomized Controlled Study to Compare Efficacy of Continuous Versus Pulsed Radiofrequency Treatment of Genicular Nerves to Alleviate Pain and Improve Functional Impairment in Patients With Advanced Osteoarthritis of the Knee

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2018
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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