Clinical trial NCT03628482: Pulsed Radiofrequency to Relieve Knee Pain
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Syndrome
Lead sponsor: Gasthuis Zusters Antwerpen
Sponsor class: OTHER
Collaborators: name: ZOL
name: Hospital General de Jerez de la Frontera
First posted: 2018-08-14
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned using a computer-generated randomization schedule to receive percutaneous radiofrequency treatment of the genicular nerves that was administered in either the continuous or in the pulsed mode.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analogue scale (VAS) score
timeFrame: VAS score at 12 months following the radiofrequency treatment.
Secondary outcomes:
measure: The Western Ontario and Mac Master Universities Osteoarthritis Index (WOMAC)
timeFrame: WOMAC score at 12 months following the radiofrequency treatment.
measure: Adverse events
timeFrame: adverse effects at 12 months following the radiofrequency treatment.
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Luc Vanlinthout
Study officials:
affiliation: ZOL
name: Jan Van Zundert
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santana-Pineda MM, Vanlinthout LE, Santana-Ramirez S, Vanneste T, Van Zundert J, Novalbos-Ruiz JP. A Randomized Controlled Trial to Compare Analgesia and Functional Improvement After Continuous Neuroablative and Pulsed Neuromodulative Radiofrequency Treatment of the Genicular Nerves in Patients with Knee Osteoarthritis up to One Year After the Intervention. Pain Med. 2021 Mar 18;22(3):637-652. doi: 10.1093/pm/pnaa309.