Osteoarthritis, KneeNCT02578108
Diagnostic Genicular Nerve Block Prior to Radiofrequency Ablation for Knee Osteoarthritis Pain
A study testing genicular nerve diagnostic block with lidocaine (local anesthetic) and genicular nerve radiofrequency ablation in people with Osteoarthritis, Knee and Pain, run by Northwestern University at 1 site in United States.
Trial summary
Chronic painful knee OA is a major cause of disability in older adults. In patients whose symptoms are refractory to conservative management but who do not wish to undergo TKA or, alternatively, are not operative candidates, genicular nerve RFA represents a promising treatment option. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Pain, Nerve; Lesion
- What is being tested?
- genicular nerve diagnostic block with lidocaine (local anesthetic) and genicular nerve radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Sep 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients ages 30-80 with chronic painful knee osteoarthritis who would undergo treatment by genicular nerve radiofrequency ablation.
- Knee pain for at least 6 months.
- Kellgren-Lawrence knee osteoarthritis of 2 or greater.
- Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy, and intra-articular injection therapy.
- No pain referral beyond the expected distribution for knee osteoarthritis.
Who cannot join
- NRS pain score of 4 or more
- Focal neurologic signs or symptoms.
- Previous radiofrequency ablation treatment for similar symptoms.
- Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
- Concomitant radicular pain.
- Previous knee surgery.
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- Patient refusal.
- Lack of consent.
- Active systemic or local infections at the site of proposed needle and electrode placement.
- Coagulopathy or other bleeding disorder, current use of anticoagulants or anti-platelet medications.
- Allergy to medications being used for injection procedures (contrast, local anesthetic).
- Inability to read English, communicate with staff, or participate in follow-up.
- Pregnancy.
- Pacemaker.
- Cognitive deficit.
- Unstable medical or psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Trial of Zero Versus One Diagnostic Genicular Nerve Blocks to Determine Clinical Outcomes After Radiofrequency Ablation for the Treatment of Chronic Painful Knee Osteoarthritis
Chronic painful knee OA is a major cause of disability in older adults. In patients whose symptoms are refractory to conservative management but who do not wish to undergo TKA or, alternatively, are not operative candidates, genicular nerve RFA represents a promising treatment option.
Investigators will determine if patients with chronic painful knee osteoarthritis experience meaningful and long-term improvement in pain, function, and analgesic use, as well as prevention of TKA after RFA of the genicular nerves. Investigators will also determine whether zero versus one set of diagnostic genicular nerve blocks
Answering these questions will help determine if genicular nerve RFA is indeed a worthwhile treatment for chronic painful knee OA. Additionally, this will help determine the optimal diagnostic protocol for patient selection for this procedure, which has implications for improving treatment success rates, preventing unnecessary procedures, and decreasing healthcare cost savings.
Read the detailed description
Knee osteoarthritis (OA) is one of the most common conditions and causes of disability in older adults, with an estimated prevalence of symptoms in 20-30% of individuals over 65 years of age. Pain associated with knee OA may have a central nervous system component, but intra-articular chemical pain mediators such as Substance P and Calcitonin-gene related peptide, possible intra-articular ischemic pain due to vasospasm, mechanical compression or irritation of the richly innervated subchondral bone, periosteum, synovium, and joint capsule, as well as peripheral genicular nerve sensitization have largely been implicated.
Knee OA, in general, is treated conservatively with weight loss (when indicated), physical therapy, oral analgesic medications, and intra-articular corticosteroid or hyaluronic acid injections. If this approach fails to provide adequate pain relief and functional restoration, patients may be offered total knee arthroplasty (TKA), if they are surgical candidates. While, TKA is generally a safe procedure, like any major open surgery, it is associated with a risk of serious complications; a large cohort study of 83,756 patients demonstrated the annual incidence of venous thromboembolism (0.6%), myocardial infarction (0.5%), stroke (0.5%), and a 90 day mortality (0.7%) to all be significantly higher than the general population. Furthermore, some patients are not candidates for TKA due to co-morbidities such as morbid obesity or cardiopulmonary disease.
Radiofrequency ablation (RFA) for knee joint denervation represents a promising intervention for patients with chronic painful knee osteoarthritis who have failed conservative management and are either not willing or not eligible for TKA. During RFA a thermal lesion is created by applying radiofrequency energy through an electrode placed at a target structure. RFA has been used to disrupt sensory afferent nociceptive nerve fibers supplying the zygapophyseal (facet) joints of the spine as well as the sacroiliac joint with excellent pain reduction and functional improvement when performed appropriately.
To date, there are only two published studies that have investigated knee joint denervation by RFA for the treatment of chronic painful OA. In a randomized prospective study (n=35), Choi et al. found that genicular nerve RFA resulted in clinically meaningful pain improvement in approximately 60% of patients at 6 month follow-up. Improvement in function was also observed. Bellini and Barbieri report a series of 3 patients with chronic painful knee OA, two of whom who experienced meaningful pain and functional improvement after genicular nerve RFA.
There is no evidence-based algorithm established which provides a means of properly selecting which patients would benefit from genicular nerve RFA. In the study performed by Choi et al., only one set of diagnostic genicular nerve blocks with a threshold of 50% pain relief to be considered a "positive response" was used. In contrast, a well developed literature regarding selection of patients for medial branch RFA for facet-mediated pain indicates that two sets of diagnostic medial branch nerve blocks with a threshold of >80% pain reduction to be considered a "positive response" increased positive predictive value for both meaningful pain and functional outcomes to 80-90%. While the diagnosis of facet-mediated pain can be challenging given the variety of potential pain generators in the spine, diagnostic uncertainly is far less likely when evaluating the knee as a pain generator. In fact, it is unclear that any diagnostic blocks of the genicular nerves are needed given that this increase the potential for complications and healthcare costs compared to proceeding directly to the ablation procedure. It is vital that evidence-based selection criteria are developed for genicular nerve RFA in order to optimize clinical outcomes and minimize healthcare costs.
- Conditions
- Osteoarthritis, Knee, Pain, Nerve; Lesion
- Being tested
- genicular nerve diagnostic block with lidocaine (local anesthetic), genicular nerve radiofrequency ablation
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genicular nerve diagnostic block with lidocaine (local anesthetic)Procedure or surgery
sensory denervation of the knee joint
genicular nerve radiofrequency ablationProcedure or surgery
Ablation of the genicular nerves of the knee by radiofrequency energy
| Study group | Role | What they receive |
|---|---|---|
| no diagnostic genicular nerve blocks | Active comparator | no diagnostic genicular nerve blocks prior to genicular nerve ablation Intervention: genicular nerve radiofrequency ablation Receives: Procedure: genicular nerve radiofrequency ablation |
| diagnostic genicular nerve blocks | Active comparator | Set of diagnostic genicular nerve blocks prior to genicular nerve ablation Intervention: genicular nerve radiofrequency ablation Receives: Procedure: genicular nerve diagnostic block with lidocaine (local anesthetic); Procedure: genicular nerve radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
>50% relief of pain from before to after radiofrequency ablation of the genicular nerves
Outcomes will be compared between those who received a set of diagnostic blocks and those who did not receive a set of diagnostic blocks (arm 1 vs. arm 2)
Measured: 6 months
Secondary outcomes (1)
Mean reduction in morphine equivalent use for knee pain from before to after radiofrequency ablation of the genicular nerves
Outcomes will be compared between those who received a set of diagnostic blocks and those who did not receive a set of diagnostic blocks (arm 1 vs. arm 2)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion1 Sep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zachary McCormick, MD, University of California, San Francisco
- Investigators
- Zachary McCormick, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578108
- Sponsor's protocol ID
- STU00201206
- Status last verified
- Sep 2017
- First submitted
- 14 Oct 2015
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Zero Versus One Diagnostic Genicular Nerve Blocks to Determine Clinical Outcomes After Radiofrequency Ablation for the Treatment of Chronic Painful Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02578108
- Acronym / sponsor ID
- STU00201206
- Conditions
- Osteoarthritis, Knee, Pain, Nerve; Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 16 Oct 2015 (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 painful knee OA is a major cause of disability in older adults. In patients whose symptoms are refractory to conservative management but who do not wish to undergo TKA or, alternatively, are not operative candidates, genicular nerve RFA represents a promising treatment option.
Investigators will determine if patients with chronic painful knee osteoarthritis experience meaningful and long-term improvement in pain, function, and analgesic use, as well as prevention of TKA after RFA of the genicular nerves. Investigators will also determine whether zero versus one set of diagnostic genicular nerve blocks
Answering these questions will help determine if genicular nerve RFA is indeed a worthwhile treatment for chronic painful knee OA. Additionally, this will help determine the optimal diagnostic protocol for patient selection for this procedure, which has implications for improving treatment success rates, preventing unnecessary procedures, and decreasing healthcare cost savings.
Detailed description
Knee osteoarthritis (OA) is one of the most common conditions and causes of disability in older adults, with an estimated prevalence of symptoms in 20-30% of individuals over 65 years of age. Pain associated with knee OA may have a central nervous system component, but intra-articular chemical pain mediators such as Substance P and Calcitonin-gene related peptide, possible intra-articular ischemic pain due to vasospasm, mechanical compression or irritation of the richly innervated subchondral bone, periosteum, synovium, and joint capsule, as well as peripheral genicular nerve sensitization have largely been implicated.
Knee OA, in general, is treated conservatively with weight loss (when indicated), physical therapy, oral analgesic medications, and intra-articular corticosteroid or hyaluronic acid injections. If this approach fails to provide adequate pain relief and functional restoration, patients may be offered total knee arthroplasty (TKA), if they are surgical candidates. While, TKA is generally a safe procedure, like any major open surgery, it is associated with a risk of serious complications; a large cohort study of 83,756 patients demonstrated the annual incidence of venous thromboembolism (0.6%), myocardial infarction (0.5%), stroke (0.5%), and a 90 day mortality (0.7%) to all be significantly higher than the general population. Furthermore, some patients are not candidates for TKA due to co-morbidities such as morbid obesity or cardiopulmonary disease.
Radiofrequency ablation (RFA) for knee joint denervation represents a promising intervention for patients with chronic painful knee osteoarthritis who have failed conservative management and are either not willing or not eligible for TKA. During RFA a thermal lesion is created by applying radiofrequency energy through an electrode placed at a target structure. RFA has been used to disrupt sensory afferent nociceptive nerve fibers supplying the zygapophyseal (facet) joints of the spine as well as the sacroiliac joint with excellent pain reduction and functional improvement when performed appropriately.
To date, there are only two published studies that have investigated knee joint denervation by RFA for the treatment of chronic painful OA. In a randomized prospective study (n=35), Choi et al. found that genicular nerve RFA resulted in clinically meaningful pain improvement in approximately 60% of patients at 6 month follow-up. Improvement in function was also observed. Bellini and Barbieri report a series of 3 patients with chronic painful knee OA, two of whom who experienced meaningful pain and functional improvement after genicular nerve RFA.
There is no evidence-based algorithm established which provides a means of properly selecting which patients would benefit from genicular nerve RFA. In the study performed by Choi et al., only one set of diagnostic genicular nerve blocks with a threshold of 50% pain relief to be considered a "positive response" was used. In contrast, a well developed literature regarding selection of patients for medial branch RFA for facet-mediated pain indicates that two sets of diagnostic medial branch nerve blocks with a threshold of >80% pain reduction to be considered a "positive response" increased positive predictive value for both meaningful pain and functional outcomes to 80-90%. While the diagnosis of facet-mediated pain can be challenging given the variety of potential pain generators in the spine, diagnostic uncertainly is far less likely when evaluating the knee as a pain generator. In fact, it is unclear that any diagnostic blocks of the genicular nerves are needed given that this increase the potential for complications and healthcare costs compared to proceeding directly to the ablation procedure. It is vital that evidence-based selection criteria are developed for genicular nerve RFA in order to optimize clinical outcomes and minimize healthcare costs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no diagnostic genicular nerve blocks | Active comparator | Procedure: genicular nerve radiofrequency ablationno diagnostic genicular nerve blocks prior to genicular nerve ablation Intervention: genicular nerve radiofrequency ablation |
| diagnostic genicular nerve blocks | Active comparator | Procedure: genicular nerve diagnostic block with lidocaine (local anesthetic), Procedure: genicular nerve radiofrequency ablationSet of diagnostic genicular nerve blocks prior to genicular nerve ablation Intervention: genicular nerve radiofrequency ablation |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients ages 30-80 with chronic painful knee osteoarthritis who would undergo treatment by genicular nerve radiofrequency ablation.
- Knee pain for at least 6 months.
- Kellgren-Lawrence knee osteoarthritis of 2 or greater.
- Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy, and intra-articular injection therapy.
- No pain referral beyond the expected distribution for knee osteoarthritis.
Key exclusion criteria (16 listed)
- NRS pain score of 4 or more
- Focal neurologic signs or symptoms.
- Previous radiofrequency ablation treatment for similar symptoms.
- Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
- Concomitant radicular pain.
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 |
|---|---|---|
| genicular nerve diagnostic block with lidocaine (local anesthetic)sensory denervation of the knee joint | Procedure or surgery | diagnostic genicular nerve blocks |
| genicular nerve radiofrequency ablationAblation of the genicular nerves of the knee by radiofrequency energy | Procedure or surgery | diagnostic genicular nerve blocks, no diagnostic genicular nerve blocks |
Primary outcome
>50% relief of pain from before to after radiofrequency ablation of the genicular nerves
Time frame: 6 months
Outcomes will be compared between those who received a set of diagnostic blocks and those who did not receive a set of diagnostic blocks (arm 1 vs. arm 2)
1 secondary outcome
Mean reduction in morphine equivalent use for knee pain from before to after radiofrequency ablation of the genicular nerves
Time frame: 6 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 21 Aug 2019.
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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.
Zachary McCormick, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genicular nerve diagnostic block with lidocaine (local anesthetic) and genicular nerve radiofrequency ablation in people with Osteoarthritis, Knee and Pain, run by Northwestern University 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 5 inclusion and 16 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 21 Aug 2019. 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. 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?
>50% relief of pain from before to after radiofrequency ablation of the genicular nerves (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2019.