Radiofrequency Ablation of Genicular Nerves for Advanced Osteoarthrosis of the Knee Joint 1 Year Follow-up.

NCT ID: NCT02688543

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-01-31

Brief Summary

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Pharmacological treatment of pain due to osteoarthritis of the knee often proves to be inadequate and/or cause intolerable side effects. Arthroplasty of the knee may offer a solution, but waiting lists may be long or certain patients may not be apt for a surgical intervention. Therefore an alternative pain treatment that is effective and has little side effects allowing to offer pain relief to those difficult to manage patients would be an added value in the therapeutic options.

We studies the short and long-term effects of radio frequency treatment of the genicular nerves in patients with severe pain due to osteoarthritis of the knee.

Detailed Description

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Radio frequency treatment (RF) of the genicular nerves was found to be effective in a randomized controlled trial. Because of the blinding patients were allowed to continue pre-intervention pharmacological treatment, which may have interfered with the outcome. The short follow-up (12 weeks) does not allow drawing conclusion on the duration of the effect.

We aimed at assessing the pain reducing effect of RF of the genicular nerves and the duration of the effect.

Conditions

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Painful Osteoarthritis of the Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RF treatment

Patients treated with radio frequency of the genicular nerves

Group Type EXPERIMENTAL

RF treatment

Intervention Type PROCEDURE

the genicular nerves are identified with the help of landmarks, ultrasound and nerve stimulation. Once the needle is correctly placed high frequency current is passed through the probe during 90 seconds at 20 V with tip temperature put to 80°C.

radiofrequency ablation

Intervention Type RADIATION

ultrasound

Intervention Type DEVICE

Interventions

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RF treatment

the genicular nerves are identified with the help of landmarks, ultrasound and nerve stimulation. Once the needle is correctly placed high frequency current is passed through the probe during 90 seconds at 20 V with tip temperature put to 80°C.

Intervention Type PROCEDURE

radiofrequency ablation

Intervention Type RADIATION

ultrasound

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients suffering from pain caused by osteoarthrosis of the knee joint
* osteoarthrosis of the knee joint (grade 3-4 according to the Kellgren Lawrence classification)
* pain of moderate to severe intensity (VAS≥5, on a 10-point scale) during \>3 months
* pain resistant to conservative treatments

Exclusion Criteria

* acute knee pain associated with radicular neuropathy or intermittent claudication, connective tissue diseases affecting the knee, serious neurologic or psychiatric disorders, mental deterioration impeding adequate communication or collaboration, injection with steroids or hyaluronic acids during the previous 3 months, anticoagulant medications, pacemakers, and prior electro-acupuncture treatment
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Ziekenhuis Oost-Limburg

OTHER

Sponsor Role collaborator

Hospital General de Jerez de la Frontera

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital General de Jerez de la Frontera (Servicio Andaluz de Salud)

Jerez de la Frontera, Cadiz, Spain

Site Status

Countries

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Spain

References

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Santana Pineda MM, Vanlinthout LE, Moreno Martin A, van Zundert J, Rodriguez Huertas F, Novalbos Ruiz JP. Analgesic Effect and Functional Improvement Caused by Radiofrequency Treatment of Genicular Nerves in Patients With Advanced Osteoarthritis of the Knee Until 1 Year Following Treatment. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):62-68. doi: 10.1097/AAP.0000000000000510.

Reference Type DERIVED
PMID: 27875368 (View on PubMed)

Other Identifiers

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RF knee 001

Identifier Type: -

Identifier Source: org_study_id

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