Painful Osteoarthritis of the KneeNCT02688543
Radiofrequency Ablation of Genicular Nerves for Advanced Osteoarthrosis of the Knee Joint 1 Year Follow-up.
A study testing RF treatment, radiofrequency ablation and ultrasound in people with Painful Osteoarthritis of the Knee, run by Hospital General de Jerez de la Frontera at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Painful Osteoarthritis of the Knee
- What is being tested?
- RF treatment, radiofrequency ablation and ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital General de Jerez de la Frontera (Servicio Andaluz de Salud)
Jerez de la Frontera, Cadiz, 11407
About this study
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
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.
- Conditions
- Painful Osteoarthritis of the Knee
- Being tested
- RF treatment, radiofrequency ablation, ultrasound
- Keywords
- radio frequency treatment, genicular nerves, osteoarthritis of the knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF treatmentProcedure or surgery
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 ablationRadiation
ultrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| RF treatment | Experimental | Patients treated with radio frequency of the genicular nerves Receives: Procedure: RF treatment; Radiation: radiofrequency ablation; Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Pain intensity is measured using a 10-point VAS score
Measured: 1, 6 and 12 months
Secondary outcomes (2)
Global patient satisfaction
Satisfaction is scored on a 4-point Likert scale: 1 (poor), 2 (average), 3 (good) and 4 (very good)
Measured: 1,6 and 12 months
Improvement of quality of life
evaluated using the Western Ontario and MacMaster Universities Index of Osteoarthrosis (WOMAC)
Measured: 1,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Painful Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Jerez de la Frontera
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688543
- Sponsor's protocol ID
- RF knee 001
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2016
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02688543
- Acronym / sponsor ID
- RF knee 001
- Conditions
- Painful Osteoarthritis of the Knee
- Keywords
- radio frequency treatment, genicular nerves, osteoarthritis of the knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital General de Jerez de la FronteraUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF treatment | Experimental | Procedure: RF treatment, Radiation: radiofrequency ablation, Device: ultrasoundPatients treated with radio frequency of the genicular nerves |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF treatmentthe 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. | Procedure or surgery | RF treatment |
| radiofrequency ablation | Radiation | RF treatment |
| ultrasound | Device | RF treatment |
Primary outcome
Pain reduction
Time frame: 1, 6 and 12 months
Pain intensity is measured using a 10-point VAS score
2 secondary outcomes
Global patient satisfaction
Time frame: 1,6 and 12 months
Improvement of quality of life
Time frame: 1,6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Derived from this study: PubMed 27875368Santana 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF treatment, radiofrequency ablation and ultrasound in people with Painful Osteoarthritis of the Knee, run by Hospital General de Jerez de la Frontera at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction (time frame: 1, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02688543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.