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

Sponsor
Hospital General de Jerez de la Frontera (Other)
Overall Status
Completed
CT.gov ID
NCT02688543
Collaborator
Ziekenhuis Oost-Limburg (Other)
25
1
1
34
0.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: RF treatment
  • Radiation: radiofrequency ablation
  • Device: ultrasound
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: RF treatment

Patients treated with radio frequency of the genicular nerves

Procedure: 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.

Radiation: radiofrequency ablation

Device: ultrasound

Outcome Measures

Primary Outcome Measures

  1. Pain reduction [1, 6 and 12 months]

    Pain intensity is measured using a 10-point VAS score

Secondary Outcome Measures

  1. Global patient satisfaction [1,6 and 12 months]

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

  2. Improvement of quality of life [1,6 and 12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital General de Jerez de la Frontera (Servicio Andaluz de Salud) Jerez de la Frontera Cadiz Spain 11407

Sponsors and Collaborators

  • Hospital General de Jerez de la Frontera
  • Ziekenhuis Oost-Limburg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital General de Jerez de la Frontera
ClinicalTrials.gov Identifier:
NCT02688543
Other Study ID Numbers:
  • RF knee 001
First Posted:
Feb 23, 2016
Last Update Posted:
Feb 23, 2016
Last Verified:
Feb 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Hospital General de Jerez de la Frontera
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2016