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

Primary Purpose

Painful Osteoarthritis of the Knee

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

RF treatment

radiofrequency ablation

ultrasound

About this trial

This is an interventional treatment trial for Painful Osteoarthritis of the Knee focused on measuring radio frequency treatment, genicular nerves, osteoarthritis of the knee

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RF treatment

Arm Description

Patients treated with radio frequency of the genicular nerves

Outcomes

Primary Outcome Measures

Pain reduction

Pain intensity is measured using a 10-point VAS score

Secondary Outcome Measures

Global patient satisfaction

Satisfaction is scored on a 4-point Likert scale: 1 (poor), 2 (average), 3 (good) and 4 (very good)

Improvement of quality of life

evaluated using the Western Ontario and MacMaster Universities Index of Osteoarthrosis (WOMAC)

Full Information

NCT ID

NCT02688543

First Posted

February 18, 2016

Last Updated

February 22, 2016

Sponsor

Hospital General de Jerez de la Frontera

Collaborators

Ziekenhuis Oost-Limburg

1. Study Identification

Unique Protocol Identification Number

NCT02688543

Brief Title

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

Official Title

Analgesic Effect and Functional Improvement Caused by Radiofrequency Ablation of Genicular Nerves in Patients With Advanced Osteoarthrosis of the Knee Joint Until 1 Year Following Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital General de Jerez de la Frontera

Collaborators

Ziekenhuis Oost-Limburg

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Painful Osteoarthritis of the Knee

Keywords

radio frequency treatment, genicular nerves, osteoarthritis of the knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RF treatment

Arm Type

Experimental

Arm Description

Patients treated with radio frequency of the genicular nerves

Intervention Type

Procedure

Intervention Name(s)

RF treatment

Intervention Description

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

Radiation

Intervention Name(s)

radiofrequency ablation

Intervention Type

Device

Intervention Name(s)

ultrasound

Primary Outcome Measure Information:

Title

Pain reduction

Description

Pain intensity is measured using a 10-point VAS score

Time Frame

1, 6 and 12 months

Secondary Outcome Measure Information:

Title

Global patient satisfaction

Description

Satisfaction is scored on a 4-point Likert scale: 1 (poor), 2 (average), 3 (good) and 4 (very good)

Time Frame

1,6 and 12 months

Title

Improvement of quality of life

Description

evaluated using the Western Ontario and MacMaster Universities Index of Osteoarthrosis (WOMAC)

Time Frame

1,6 and 12 months

10. Eligibility

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Jerez de la Frontera

State/Province

Cadiz

ZIP/Postal Code

11407

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27875368

Citation

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.

Results Reference

derived

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

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