Pulsed Radiofrequency to Relieve Knee Pain

NCT03628482 | Completed DMC

• 1 other identifier: MMSP-LV2
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS) score

  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.

  VAS score at 12 months following the radiofrequency treatment.

Secondary Outcomes (2)

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

  WOMAC score at 12 months following the radiofrequency treatment.

• Adverse events

  adverse effects at 12 months following the radiofrequency treatment.

Study Arms (2)

CRF group

ACTIVE COMPARATOR

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

Procedure: CRF

PRF group

EXPERIMENTAL

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

Procedure: PRF

Interventions

CRF PROCEDURE

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

Also known as: Continuous radiofrequency treatment

CRF group

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.

Also known as: Pulsed radiofrequency treatment

PRF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Gasthuis Zusters Antwerpen: lead
• ZOL: collaborator
• Hospital General de Jerez de la Frontera: collaborator

Study Sites (1)

Luc Vanlinthout

Antwerp, 2018, Belgium

Location

Related Publications (1)

• 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.

  PMID: 33179073 DERIVED

MeSH Terms

Conditions

Somatoform Disorders

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Officials

• Jan Van Zundert

  ZOL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were randomly assigned using a computer-generated randomization schedule to receive either continuous or pulsed radiofrequency treatment of genicular nerves. The allocation sequence was concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. The corresponding envelopes were opened only at the time of intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 14, 2018
• Study Start: February 15, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: February 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)