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Osteoarthritis, KneePhase 4NCT06000709

Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections

A Phase 4 study testing 6% aqueous phenol and MethylPREDNISolone 40 MG in people with Osteoarthritis, Knee and Chronic Knee Pain, run by University of Manitoba.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Genicular nerve neurolysis (GN) constitutes a relatively novel technique, whereby different chemical compounds (i.e. alcohol, phenol) are injected in close proximity to the genicular nerves of the knee joint, with the intention to exert a neurolytic effect by denaturing proteins resulting in Wallerian degeneration… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Osteoarthritis, Knee, Chronic Knee Pain
What is being tested?
6% aqueous phenol and MethylPREDNISolone 40 MG
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
No sites listed yet
Study dates
20 Oct 2023to 31 Jul 2024
Phase
Phase 4
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Severe knee pain for more than 6 months, defined as Numeric rating scale (NRS) score of 6 and greater, unresponsive to conservative medical treatment
  • Radiological OA grade 2 to 4 (Kellgren-Lawrence scale)

Who cannot join

  • Previous total knee replacement on the index knee
  • Prior knee radiofrequency ablation on the index knee
  • Connective tissue diseases with knee involvement (e.g. rheumatoid arthritis)
  • Body mass index ≥ 40 kg/m2
  • Uncontrolled coagulopathy, defined as supratherapeutic dose of anticoagulation medication
  • Allergy to local anesthetics
  • Unstable opioid consumption, defined as an increase >10% in dosage during the last 3 months prior to recruitment.

Trial locations and contacts

No sites are listed yet.

Javier Webar, MD contact

2047873018

javier.webar@umanitoba.ca

Sebastian Layera, MD contact

2047873018

layerars@myumanitoba.ca

About this study

Official title: Randomized, Double-blinded, Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections

Genicular nerve neurolysis (GN) constitutes a relatively novel technique, whereby different chemical compounds (i.e. alcohol, phenol) are injected in close proximity to the genicular nerves of the knee joint, with the intention to exert a neurolytic effect by denaturing proteins resulting in Wallerian degeneration distal to the lesion. Based on the preliminary evidence and considering the potential benefits of the technique, we hypothesized that ultrasound-guided genicular chemical neurolysis with phenol is superior in terms of pain relief at 3 months, when compared to intra-articular steroid (IAS) injection.

Read the detailed description

This study will allow us to determine if ultrasound-guided phenol genicular neurolys is superior to intra-articular steroid injection in terms of analgesia and functional outcomes, providing a more effective and long-lasting alternative for patients with chronic knee pain secondary to osteoarthritis

Being tested
6% aqueous phenol, MethylPREDNISolone 40 MG, Intraarticular Knee Placebo, Genicular Nerve Placebo
Keywords
Phenol, Injections, Intra-Articular, Steroids, Nerve Block
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6% aqueous phenolDrug

    1.5 mL of aqueous phenol will be injected at each target genicular nerve under ultrasound guidance

  • MethylPREDNISolone 40 MGDrug

    40 mg of methylprednisolone diluted in 5 mL of 0.9% normal saline will be injected inside the knee joint capsule under ultrasound guidance

  • Intraarticular Knee PlaceboDrug

    Also called 0.9% normal saline

    Single injection 1.5 mL of 0.9% normal saline outside the knee joint capsule under ultrasound guidance

  • Genicular Nerve PlaceboDrug

    Also called 0.9% normal saline

    1.5 mL of 0.9% normal saline will be injected subcutaneously at each target genicular nerve under ultrasound guidance

Study groups in NCT06000709
Study groupRoleWhat they receive
Ultrasound-guided Genicular Nerve Phenol NeurolysisExperimentalOne time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves
Receives: Drug: 6% aqueous phenol; Drug: Intraarticular Knee Placebo
Ultrasound-guided Intraarticular Steroid InjectionActive comparatorIntraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline
Receives: Drug: MethylPREDNISolone 40 MG; Drug: Genicular Nerve Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain scores (Numeric Rating Scale) at 3 months

    Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

    Measured: 3 months

Secondary outcomes (5)

  1. Pain scores (Numeric Rating Scale) at baseline, 1 and 6 months

    Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

    Measured: baseline, 1 month, 6 months

  2. Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS)

    Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

    Measured: 1 months, 3 months, 6 months

  3. Brief Pain Inventory Score (BPI)

    Functional activity measurement using the Brief Pain Inventory (short form)

    Measured: baseline, 1 month, 3 months, 6 months

  4. WOMAC index

    The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall)

    Measured: baseline, 1 month, 3 months, 6 months

  5. Incidence of adverse events

    Determined by the presence of hypoesthesia, paresthesia, puncture site hematoma, and worsening pain or infection

    Measured: from injection up to 1 month after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start20 Oct 2023 (estimated)
  3. Primary completion31 Jan 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06000709
Sponsor's protocol ID
HS25899
Status last verified
Oct 2023
First submitted
14 Aug 2023
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Walega DR, McCormick ZL. Chemical Neurolysis of the Genicular Nerves for Chronic Knee Pain: Reviving an Old Dog and an Old Trick. Pain Med. 2018 Sep 1;19(9):1882-1884. doi: 10.1093/pm/pny023. No abstract available.

    PubMed 29514315

  • Risso RC, Ferraro LHC, Nouer Frederico T, Peng PWH, Luzo MV, Debieux P, Sakata RK. Chemical Ablation of Genicular Nerve with Phenol for Pain Relief in Patients with Knee Osteoarthritis: A Prospective Study. Pain Pract. 2021 Apr;21(4):438-444. doi: 10.1111/papr.12972. Epub 2020 Dec 29.

    PubMed 33277760

  • Park Y, Lee SC, Nam HS, Lee J, Nam SH. Comparison of sonographically guided intra-articular injections at 3 different sites of the knee. J Ultrasound Med. 2011 Dec;30(12):1669-76. doi: 10.7863/jum.2011.30.12.1669.

    PubMed 22124002

  • Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.

    PubMed 29095245

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 6% aqueous phenol and MethylPREDNISolone 40 MG in people with Osteoarthritis, Knee and Chronic Knee Pain, run by University of Manitoba.

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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Javier Webar, MD (2047873018, javier.webar@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain scores (Numeric Rating Scale) at 3 months (time frame: 3 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 NCT06000709, 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 10 Oct 2023.

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