CClinicalTrials.gg
CompletedNCT02688543Updated Feb 23, 2016

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

An interventional study of RF treatment and radiofrequency ablation in Painful Osteoarthritis of the Knee, sponsored by Hospital General de Jerez de la Frontera. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2016-02-23.

Sponsored by Hospital General de Jerez de la Frontera · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
01

Study 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.

Read the 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.

02

Conditions studied

  • Painful Osteoarthritis of the Knee

Keywords

  • radio frequency treatment
  • genicular nerves
  • osteoarthritis of the knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 25 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

This is the only study on the registry with Hospital General de Jerez de la Frontera as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    RF treatment

    Patients treated with radio frequency of the genicular nerves

    Procedure: RF treatment · Radiation: radiofrequency ablation · Device: ultrasound

Interventions

  • ProcedureRF 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.

  • Radiationradiofrequency ablation
  • Deviceultrasound
06

What researchers measure

Primary outcomes

  1. Pain reduction

    Pain intensity is measured using a 10-point VAS score

    Time frame: 1, 6 and 12 months

Secondary outcomes

  1. Global patient satisfaction

    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

  2. Improvement of quality of life

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

    Time frame: 1,6 and 12 months

07

Study locations

1 site
  • Hospital General de Jerez de la Frontera (Servicio Andaluz de Salud)
    Jerez de la Frontera, Cadiz 11407, Spain
08

References and documents

Publications

  • 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. PubMed 27875368 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02688543
Lead sponsor
Hospital General de Jerez de la Frontera
Collaborators
Ziekenhuis Oost-Limburg
Responsible party
Sponsor
First posted
Feb 23, 2016
Start date
Mar 2013
Primary completion
Mar 2014
Completion
Jan 2016
Last update
Feb 23, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion