Pulsed Radiofrequency to Relieve Knee Pain

NCT ID: NCT03628482

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-15
• Study Completion Date: 2019-12-15

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.

Conditions

Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

CRF group

Patients were assigned to receive continuous radiofrequency (CRF) treatment of genicular nerves

Group Type: ACTIVE_COMPARATOR

CRF

Intervention Type: PROCEDURE

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

PRF group

Patients were assigned to receive pulsed radiofrequency (CRF) treatment of genicular nerves

Group Type: EXPERIMENTAL

PRF

Intervention Type: 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.

Interventions

CRF

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

Intervention Type: PROCEDURE

PRF

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.

Intervention Type: PROCEDURE

Other Intervention Names

Continuous radiofrequency treatment; Pulsed radiofrequency treatment

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZOL

OTHER

Sponsor Role: collaborator

Hospital General de Jerez de la Frontera

OTHER

Sponsor Role: collaborator

Gasthuis Zusters Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Van Zundert

Role: PRINCIPAL_INVESTIGATOR

ZOL

Locations

Luc Vanlinthout

Antwerp, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 33179073 (View on PubMed)

Other Identifiers

MMSP-LV2

Identifier Type: -

Identifier Source: org_study_id