Chronic Knee PainDEFIANTNCT02931435
Radiofrequency For Chronic Knee Pain Post-Arthroplasty
A study testing Nerve Block with Radiofrequency Ablation in people with Chronic Knee Pain and Osteoarthritis, Knee, run by Randall Brewer, MD, CPI at 1 site in United States.
Trial summary
Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Knee Pain, Osteoarthritis, Knee
- What is being tested?
- Nerve Block with Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 30 Nov 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study candidate must provide written informed consent.
- Must be ≥ 50 years of age at the time of consent
- Chronic knee pain despite total knee arthroplasty at least 6 months prior to consent
- Orthopedic evaluation indicating no further surgery is warranted
- Stable pain medication regimen for 30 days prior to baseline visit
- Knee pain is primary pain complaint
Who cannot join
- Acute knee pain
- Connective tissue disorders affecting the knee
- Serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the Principal Investigator
- Steroid or hyaluronic acid injections into the affected knee in the past 3 months
- Confounding pain conditions of the index leg that may affect medication requirements or study outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
WK River Cities Clinical Research Center
Shreveport, Louisiana, 71105
About this study
Official title: Radiofrequency For The Treatment Of Chronic Knee Pain Following Total Knee Arthroplasty: A Double-Blind Randomized Controlled Pilot Study
Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.
The purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.
Read the detailed description
Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.
As the prevalence of knee arthroplasty increases, so does the frequency of revisions. It has been found that 20% of patients reporting painful knee arthroplasties were not able to be diagnosed with a specific cause and were therefore referred to a pain specialist. Pharmacologic therapy and non-surgical interventions are often employed with minimal benefit to the patient's level of disability as indicated by clinical evidence.
Genicular radiofrequency ablation seems to be a safe, effective and minimally invasive therapy for chronic knee OA patients who have had a positive diagnostic block. No study has determined whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain. The investigators propose to examine the effect of genicular radiofrequency ablation in chronic post-arthroplasty knee pain in patients who respond positively to diagnostic nerve blocks.
- Conditions
- Chronic Knee Pain, Osteoarthritis, Knee
- Being tested
- Nerve Block with Radiofrequency Ablation, Nerve Block with Sham Radiofrequency Ablation
- Keywords
- Genicular Radiofrequency Ablation, Knee Arthroplasty, Total
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Block with Radiofrequency AblationProcedure or surgery
Ablation of the genicular nerves of the knee by radiofrequency
Nerve Block with Sham Radiofrequency AblationProcedure or surgery
Genicular radiofrequency of the knee without neurotomy
| Study group | Role | What they receive |
|---|---|---|
| Nerve Block with Radiofrequency Ablation | Active comparator | A 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator activation. Receives: Procedure: Nerve Block with Radiofrequency Ablation |
| Nerve Block with Sham Radiofrequency Ablation | Sham comparator | A 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance.Control patients will undergo the same procedure without RF generator activation. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator sham activation. Receives: Procedure: Nerve Block with Sham Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in knee pain intensities as indicated on the Visual Analog Scale
Measured: Baseline and 6 weeks post-radiofrequency ablation
Secondary outcomes (7)
Change in Visual Analog Score of average knee pain
Measured: Baseline to 1 week, 6 weeks, and 12 weeks
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Baseline to 1 week, 6 weeks, and 12 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: Baseline to 1 week, 6 weeks, and 12 weeks
Change of Patient Global Assessment
Measured: Baseline to 1 week, 6 weeks, and 12 weeks
Satisfaction with Radiofrequency Procedure
Measured: Baseline to 1 week, 6 weeks, and 12 weeks
Rate of procedure-related Adverse Events
Measured: From informed consent through study completion, up to 20 weeks
Rate of Serious Adverse Events
Measured: From informed consent through study completion, up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startDec 2016
- Primary completion20 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Knee PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Randall Brewer, MD, CPI
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Abbott
- Responsible party
- Sponsor-investigator, Randall Brewer, MD, CPI, Willis-Knighton River Cities Clinical Research Center
- Investigators
- Randall Brewer, MD, Principal investigator, WK River Cities Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931435
- Sponsor's protocol ID
- GENRF
- Acronym
- DEFIANT
- Status last verified
- Dec 2018
- First submitted
- 5 Oct 2016
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Nikolaou VS, Chytas D, Babis GC. Common controversies in total knee replacement surgery: Current evidence. World J Orthop. 2014 Sep 18;5(4):460-8. doi: 10.5312/wjo.v5.i4.460. eCollection 2014 Sep 18.
PubMed 25232522Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
PubMed 21055873Al-Hadithy N, Rozati H, Sewell MD, Dodds AL, Brooks P, Chatoo M. Causes of a painful total knee arthroplasty. Are patients still receiving total knee arthroplasty for extrinsic pathologies? Int Orthop. 2012 Jun;36(6):1185-9. doi: 10.1007/s00264-011-1473-6. Epub 2012 Jan 11.
PubMed 22234706
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency For The Treatment Of Chronic Knee Pain Following Total Knee Arthroplasty: A Double-Blind Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02931435
- Acronym / sponsor ID
- DEFIANT / GENRF
- Conditions
- Chronic Knee Pain, Osteoarthritis, Knee
- Keywords
- Genicular Radiofrequency Ablation, Knee Arthroplasty, Total
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Randall Brewer, MD, CPIUniversity, hospital or other
- Collaborators
- Abbott Medical Devices, Abbott
- Study start
- Dec 2016
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 13 Oct 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.
Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.
The purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.
Detailed description
Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.
As the prevalence of knee arthroplasty increases, so does the frequency of revisions. It has been found that 20% of patients reporting painful knee arthroplasties were not able to be diagnosed with a specific cause and were therefore referred to a pain specialist. Pharmacologic therapy and non-surgical interventions are often employed with minimal benefit to the patient's level of disability as indicated by clinical evidence.
Genicular radiofrequency ablation seems to be a safe, effective and minimally invasive therapy for chronic knee OA patients who have had a positive diagnostic block. No study has determined whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain. The investigators propose to examine the effect of genicular radiofrequency ablation in chronic post-arthroplasty knee pain in patients who respond positively to diagnostic nerve blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve Block with Radiofrequency Ablation | Active comparator | Procedure: Nerve Block with Radiofrequency AblationA 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator activation. |
| Nerve Block with Sham Radiofrequency Ablation | Sham comparator | Procedure: Nerve Block with Sham Radiofrequency AblationA 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance.Control patients will undergo the same procedure without RF generator activation. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator sham activation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Study candidate must provide written informed consent.
- Must be ≥ 50 years of age at the time of consent
- Chronic knee pain despite total knee arthroplasty at least 6 months prior to consent
- Orthopedic evaluation indicating no further surgery is warranted
- Stable pain medication regimen for 30 days prior to baseline visit
Key exclusion criteria (5 listed)
- Acute knee pain
- Connective tissue disorders affecting the knee
- Serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the Principal Investigator
- Steroid or hyaluronic acid injections into the affected knee in the past 3 months
- Confounding pain conditions of the index leg that may affect medication requirements or study outcomes
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 |
|---|---|---|
| Nerve Block with Radiofrequency AblationAblation of the genicular nerves of the knee by radiofrequency | Procedure or surgery | Nerve Block with Radiofrequency Ablation |
| Nerve Block with Sham Radiofrequency AblationGenicular radiofrequency of the knee without neurotomy | Procedure or surgery | Nerve Block with Sham Radiofrequency Ablation |
Primary outcome
Mean difference in knee pain intensities as indicated on the Visual Analog Scale
Time frame: Baseline and 6 weeks post-radiofrequency ablation
7 secondary outcomes
Change in Visual Analog Score of average knee pain
Time frame: Baseline to 1 week, 6 weeks, and 12 weeks
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline to 1 week, 6 weeks, and 12 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline to 1 week, 6 weeks, and 12 weeks
Change of Patient Global Assessment
Time frame: Baseline to 1 week, 6 weeks, and 12 weeks
Satisfaction with Radiofrequency Procedure
Time frame: Baseline to 1 week, 6 weeks, and 12 weeks
Rate of procedure-related Adverse Events
Time frame: From informed consent through study completion, up to 20 weeks
Rate of Serious Adverse Events
Time frame: From informed consent through study completion, up to 20 weeks
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 13 Dec 2018.
- Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Background: PubMed 25232522Nikolaou VS, Chytas D, Babis GC. Common controversies in total knee replacement surgery: Current evidence. World J Orthop. 2014 Sep 18;5(4):460-8. doi: 10.5312/wjo.v5.i4.460. eCollection 2014 Sep 18.
- Background: PubMed 21055873Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
- Background: PubMed 22234706Al-Hadithy N, Rozati H, Sewell MD, Dodds AL, Brooks P, Chatoo M. Causes of a painful total knee arthroplasty. Are patients still receiving total knee arthroplasty for extrinsic pathologies? Int Orthop. 2012 Jun;36(6):1185-9. doi: 10.1007/s00264-011-1473-6. Epub 2012 Jan 11.
- Individual participant dataSharing planned: Undecided
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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.
Randall Brewer, MD principal investigator
WK River Cities Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Block with Radiofrequency Ablation in people with Chronic Knee Pain and Osteoarthritis, Knee, run by Randall Brewer, MD, CPI at 1 site in United States.
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 6 inclusion and 5 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 13 Dec 2018. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Mean difference in knee pain intensities as indicated on the Visual Analog Scale (time frame: Baseline and 6 weeks post-radiofrequency ablation). 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 NCT02931435, which also lists 4 linked publications.
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 13 Dec 2018.