Pain SyndromeNCT03628482
Pulsed Radiofrequency to Relieve Knee Pain
A study testing CRF and PRF in people with Pain Syndrome, run by Gasthuis Zusters Antwerpen at 1 site in Belgium.
Trial summary
Knee osteoarthritis is a leading cause of chronic pain, disability, and decreased quality of life. Lesioning of genicular nerves by continuous radiofrequency treatment proved to be effective in relieving pain and disability caused by osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Syndrome
- What is being tested?
- CRF and PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2018to 15 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients suffered from chronic pain (during>6months) of moderate to severe intensity (scoring ≥5 on a 0- to 10-point continuous visual analog scale [VAS] ranging from none [0] to an extreme amount of pain [10]) due to advanced osteoarthritis of the knee (grades 3-4 according to the Kellgren-Lawrence classification. The pain proved to be resistant to conservative treatments including physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids. In this study, genicular nerve ablation was applied as an alternative analgesic approach for those who refused knee arthroplasty; were judged by their surgeons as being inappropriate for surgical treatment, for example, because of cardiovascular or other comorbidities; or who had to be managed for persistent pain and stiffness after total knee arthroplasty.
Who cannot join
- The exclusion criteria included knee-pain related disorders that might benefit from other interventions, for example, patellofemoral disorders, meniscal injuries, ligamentous laxity, and so on, acute knee pain associated with radicular neuropathy or intermittent claudication, connective tissue diseases, serious neurologic or psychiatric disorders, mental deterioration impeding adequate communication or collaboration, anticoagulant medications, pacemakers, prior electroacupuncture treatment, and injection with steroids or hyaluronic acids during the previous 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study to Compare Efficacy of Continuous Versus Pulsed Radiofrequency Treatment of Genicular Nerves to Alleviate Pain and Improve Functional Impairment in Patients With Advanced Osteoarthritis of the Knee
Knee osteoarthritis is a leading cause of chronic pain, disability, and decreased quality of life. Lesioning of genicular nerves by continuous radiofrequency treatment proved to be effective in relieving pain and disability caused by osteoarthritis of the knee. In contrast to continuous radiofrequency lesioning, pulsed radiofrequency treatment offers pain control with no or only minimal histological lesions. As a non-destructive alternative to continuous radiofrequency ablation, pulsed radiofrequency treatment may have inherent appeal because it may mitigate concerns regarding complications associated with the ablation of nerves. However, studies comparing the ability of the continuous and the pulsed modalities of radiofrequency treatment to relieve pain and incapacity due to osteoarthritis of the knee are lacking. Therefore, it was the aim of the investigators of current study to compare efficacy of continuous and pulsed radiofrequency treatments of genicular nerves to alleviate pain and disability in patients with advanced osteoarthritis of the knee.
Read the detailed description
Following approval of the Regional Research Ethics Committee written informed consent was obtained from all patients. Current randomized controlled trial included patients with grade 3-4 gonarthritis suffering from intractable knee pain, scoring ≥5 on the Visual Analog Scale (VAS) during >6 months. Therapy was based on ultrasound guided radiofrequency treatment of the superior medial, superior lateral and inferior medial genicular nerves. VAS and Western Ontario and MacMaster Universities Osteoarthrosis (WOMAC) scores were assessed before therapy and at 1, 6 and 12 months following intervention. Eligible patients were randomized in two treatment groups according to the modality of radiofrequency current to which targeted genicular nerves had to be exposed, i.e, the pulsed and the continuous radiofrequency groups. Both two way repeated measures analysis of variance and generalized estimating equations were used to determine whether the VAS and WOMAC scores obtained with either the continuous or the pulsed radiofrequency modalities at each of the 4 times of assessment, i.e. at pre-treatment control and at 1, 6 and 12 months after the intervention, were different.
- Conditions
- Pain Syndrome
- Being tested
- CRF, PRF
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRFProcedure or surgery
Also called Continuous radiofrequency treatment
For continuous radiofrequency ablation the electrode tip temperature was raised to 80°C during 90 s.
PRFProcedure or surgery
Also called Pulsed radiofrequency treatment
The procedure for PRF is almost identical to that applied for CRF, except that the current is typically carried out in 20 ms pulses every 0.5 s at a temperature that does not exceed 42 °C during 360 s.
| Study group | Role | What they receive |
|---|---|---|
| CRF group | Active comparator | Patients were assigned to receive continuous radiofrequency (CRF) treatment of genicular nerves Receives: Procedure: CRF |
| PRF group | Experimental | Patients were assigned to receive pulsed radiofrequency (CRF) treatment of genicular nerves Receives: Procedure: PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) score
The pain VAS is a unidimensional measure of pain intensity (1), rated on a continuous scale which is 10 centimeters in length, and anchored by 2 verbal descriptors, one for each symptom extreme , " no pain " and " worst imaginable pain ". Our null hypothesis was that no significant difference would exist in VAS scores between the continuous and the pulsed radiofrequency groups at 12 months following the intervention.
Measured: VAS score at 12 months following the radiofrequency treatment.
Secondary outcomes (2)
The Western Ontario and Mac Master Universities Osteoarthritis Index (WOMAC)
The Western Ontario and Mac Master Universities Osteoarthritis Index (WOMAC) is a standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. Our null hypothesis was that no significant difference would exist in the WOMAC scores between the continuous and the pulsed radiofrequency groups at 12 months following the intervention.
Measured: WOMAC score at 12 months following the radiofrequency treatment.
Adverse events
Adverse effects including abnormal proprioception, numbness, paresthesia, neuralgia, and motor weakness were recorded.
Measured: adverse effects at 12 months following the radiofrequency treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start15 Feb 2018
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
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 Pain SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned using a computer-generated randomization schedule to receive percutaneous radiofrequency treatment of the genicular nerves that was administered in either the continuous or in the pulsed mode.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gasthuis Zusters Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- ZOL, Hospital General de Jerez de la Frontera
- Responsible party
- Sponsor
- Investigators
- Jan Van Zundert, Principal investigator, ZOL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628482
- Sponsor's protocol ID
- MMSP-LV2
- Status last verified
- Feb 2021
- First submitted
- 6 Aug 2018
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared when current study has been published
Publications
Santana-Pineda MM, Vanlinthout LE, Santana-Ramirez S, Vanneste T, Van Zundert J, Novalbos-Ruiz JP. A Randomized Controlled Trial to Compare Analgesia and Functional Improvement After Continuous Neuroablative and Pulsed Neuromodulative Radiofrequency Treatment of the Genicular Nerves in Patients with Knee Osteoarthritis up to One Year After the Intervention. Pain Med. 2021 Mar 18;22(3):637-652. doi: 10.1093/pm/pnaa309.
PubMed 33179073
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Compare Efficacy of Continuous Versus Pulsed Radiofrequency Treatment of Genicular Nerves to Alleviate Pain and Improve Functional Impairment in Patients With Advanced Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03628482
- Acronym / sponsor ID
- MMSP-LV2
- Conditions
- Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Gasthuis Zusters AntwerpenUniversity, hospital or other
- Collaborators
- ZOL, Hospital General de Jerez de la Frontera
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- 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.
Knee osteoarthritis is a leading cause of chronic pain, disability, and decreased quality of life. Lesioning of genicular nerves by continuous radiofrequency treatment proved to be effective in relieving pain and disability caused by osteoarthritis of the knee. In contrast to continuous radiofrequency lesioning, pulsed radiofrequency treatment offers pain control with no or only minimal histological lesions. As a non-destructive alternative to continuous radiofrequency ablation, pulsed radiofrequency treatment may have inherent appeal because it may mitigate concerns regarding complications associated with the ablation of nerves. However, studies comparing the ability of the continuous and the pulsed modalities of radiofrequency treatment to relieve pain and incapacity due to osteoarthritis of the knee are lacking. Therefore, it was the aim of the investigators of current study to compare efficacy of continuous and pulsed radiofrequency treatments of genicular nerves to alleviate pain and disability in patients with advanced osteoarthritis of the knee.
Detailed description
Following approval of the Regional Research Ethics Committee written informed consent was obtained from all patients. Current randomized controlled trial included patients with grade 3-4 gonarthritis suffering from intractable knee pain, scoring ≥5 on the Visual Analog Scale (VAS) during >6 months. Therapy was based on ultrasound guided radiofrequency treatment of the superior medial, superior lateral and inferior medial genicular nerves. VAS and Western Ontario and MacMaster Universities Osteoarthrosis (WOMAC) scores were assessed before therapy and at 1, 6 and 12 months following intervention. Eligible patients were randomized in two treatment groups according to the modality of radiofrequency current to which targeted genicular nerves had to be exposed, i.e, the pulsed and the continuous radiofrequency groups. Both two way repeated measures analysis of variance and generalized estimating equations were used to determine whether the VAS and WOMAC scores obtained with either the continuous or the pulsed radiofrequency modalities at each of the 4 times of assessment, i.e. at pre-treatment control and at 1, 6 and 12 months after the intervention, were different.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned using a computer-generated randomization schedule to receive percutaneous radiofrequency treatment of the genicular nerves that was administered in either the continuous or in the pulsed mode.
| Arm | Type | Receives |
|---|---|---|
| CRF group | Active comparator | Procedure: CRFPatients were assigned to receive continuous radiofrequency (CRF) treatment of genicular nerves |
| PRF group | Experimental | Procedure: PRFPatients were assigned to receive pulsed radiofrequency (CRF) treatment of genicular nerves |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients suffered from chronic pain (during>6months) of moderate to severe intensity (scoring ≥5 on a 0- to 10-point continuous visual analog scale [VAS] ranging from none [0] to an extreme amount of pain [10]) due to advanced osteoarthritis of the knee (grades 3-4 according to the Kellgren-Lawrence classification. The pain proved to be resistant to conservative treatments including physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids. In this study, genicular nerve ablation was applied as an alternative analgesic approach for those who refused knee arthroplasty; were judged by their surgeons as being inappropriate for surgical treatment, for example, because of cardiovascular or other comorbidities; or who had to be managed for persistent pain and stiffness after total knee arthroplasty.
Key exclusion criteria (1 listed)
- The exclusion criteria included knee-pain related disorders that might benefit from other interventions, for example, patellofemoral disorders, meniscal injuries, ligamentous laxity, and so on, acute knee pain associated with radicular neuropathy or intermittent claudication, connective tissue diseases, serious neurologic or psychiatric disorders, mental deterioration impeding adequate communication or collaboration, anticoagulant medications, pacemakers, prior electroacupuncture treatment, and injection with steroids or hyaluronic acids during the previous 6 months.
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 |
|---|---|---|
| CRFAlso: Continuous radiofrequency treatmentFor continuous radiofrequency ablation the electrode tip temperature was raised to 80°C during 90 s. | Procedure or surgery | CRF group |
| PRFAlso: Pulsed radiofrequency treatmentThe procedure for PRF is almost identical to that applied for CRF, except that the current is typically carried out in 20 ms pulses every 0.5 s at a temperature that does not exceed 42 °C during 360 s. | Procedure or surgery | PRF group |
Primary outcome
Visual analogue scale (VAS) score
Time frame: VAS score at 12 months following the radiofrequency treatment.
The pain VAS is a unidimensional measure of pain intensity (1), rated on a continuous scale which is 10 centimeters in length, and anchored by 2 verbal descriptors, one for each symptom extreme , " no pain " and " worst imaginable pain ". Our null hypothesis was that no significant difference would exist in VAS scores between the continuous and the pulsed radiofrequency groups at 12 months following the intervention.
2 secondary outcomes
The Western Ontario and Mac Master Universities Osteoarthritis Index (WOMAC)
Time frame: WOMAC score at 12 months following the radiofrequency treatment.
Adverse events
Time frame: adverse effects at 12 months following the radiofrequency treatment.
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 2 Feb 2021.
- Derived from this study: PubMed 33179073Santana-Pineda MM, Vanlinthout LE, Santana-Ramirez S, Vanneste T, Van Zundert J, Novalbos-Ruiz JP. A Randomized Controlled Trial to Compare Analgesia and Functional Improvement After Continuous Neuroablative and Pulsed Neuromodulative Radiofrequency Treatment of the Genicular Nerves in Patients with Knee Osteoarthritis up to One Year After the Intervention. Pain Med. 2021 Mar 18;22(3):637-652. doi: 10.1093/pm/pnaa309.
- Individual participant dataSharing planned: No. IPD will be shared when current study has been published
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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.
Jan Van Zundert principal investigator
ZOL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRF and PRF in people with Pain Syndrome, run by Gasthuis Zusters Antwerpen at 1 site in Belgium.
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 1 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 2 Feb 2021. 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 Belgium. 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?
Visual analogue scale (VAS) score (time frame: VAS score at 12 months following the radiofrequency treatment.). 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 NCT03628482, 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 2 Feb 2021.