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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.
Show all 16Show fewer
  • 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.

United States1 site
  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

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.

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 groups in NCT02578108
Study groupRoleWhat they receive
no diagnostic genicular nerve blocksActive comparatorno diagnostic genicular nerve blocks prior to genicular nerve ablation Intervention: genicular nerve radiofrequency ablation
Receives: Procedure: genicular nerve radiofrequency ablation
diagnostic genicular nerve blocksActive comparatorSet 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.

  1. >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)
  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.

  1. First posted16 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion1 Sep 2018
  4. Study completionSep 2018

Resources

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)
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

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.

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