Osteoarthritis, KneePhase 4NCT04989660
Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain
A Phase 4 study testing 6% aqueous phenol and Isotonic saline in people with Osteoarthritis, Knee and Knee Pain Chronic, run by Kessler Foundation at 1 site in United States.
Trial summary
As the aging and obese populations continue to increase, there is a rapidly growing number of people at risk for knee osteoarthritis. Treatment typically starts conservatively with analgesics, physical therapy, and bracing. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Knee Pain Chronic
- What is being tested?
- 6% aqueous phenol and Isotonic saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to Oct 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Radiographic knee osteoarthritis (Kellgren-Lawrence grade 2-4)
- Knee pain of moderate intensity or greater (NRS of 4 or greater)
- Knee pain for 3 months or longer
- Persistent knee pain despite conservative treatment including oral/topical analgesics, physiotherapy, intra-articular injection with corticosteroid and/or hyaluronic acid
Who cannot join
- Prior total or partial knee arthroplasty in the knee(s) to be treated
- Prior radiofrequency ablation treatment in the affected knee
- Other rheumatological or connective tissue disease(s) affecting the knee to be treated
- History of bleeding disorder
- Any psychiatric or neurologic disease (eg. dementia, brain injury, etc.) that may preclude reliable reporting of symptoms and response to treatment
- Pregnancy
Show all 9Show fewer
- Recent treatment with intraarticular hyaluronic acid, platelet-rich plasma, or corticosteroid injections to the affected knee in the past 3 months
- Skin or joint infection in the knee(s) to be treated
- Concomitant radicular pain
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
Paul So, MD
Matthew Delbert, MD
About this study
As the aging and obese populations continue to increase, there is a rapidly growing number of people at risk for knee osteoarthritis. Treatment typically starts conservatively with analgesics, physical therapy, and bracing. Intra-articular injections with corticosteroids and/or viscosupplementation may also be utilized in those with persistent knee pain. Genicular nerve radiofrequency ablation (GNRFA) is an increasingly employed procedure for refractory osteoarthritic knee pain with promising efficacy for pain relief. However, due to its reliance on expensive equipment, additional staff, and need for specialized rooms (eg. fluoroscopy suite), GNRFA is a costly procedure with limited availability. Chemical neurolysis is an alternative method of nerve ablation using alcohol or phenol utilized in the management of pain. Recent literature has demonstrated good efficacy for pain relief and function with chemical ablation of the genicular nerves using both alcohol and phenol.
This study is a double-blind, randomized, placebo-controlled pilot study to assess the efficacy of phenol neurolysis of the genicular nerves for pain and function due to refractory osteoarthritic knee pain. We hypothesize that a significant improvement in both pain and function will be observed with chemical neurolysis of the genicular nerves using 6% phenol compared to placebo.
- Conditions
- Osteoarthritis, Knee, Knee Pain Chronic
- Being tested
- 6% aqueous phenol, Isotonic saline
- 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
Also called Phenol
1.5 mL of 6% aqueous phenol will be injected at each target genicular nerve under ultrasound guidance.
Isotonic salineDrug
1.5 mL of isotonic saline will be injected at each target genicular nerve under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 6% aqueous phenol, 1.5 mL per target site Receives: Drug: 6% aqueous phenol |
| Placebo Group | Placebo comparator | Isotonic saline, 1.5 mL per target site Receives: Drug: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NRS pain score from baseline
Participants' pain will be measured using the numeric rating scale (0-10) prior to the intervention and at 1 month, 3 months, and 6 months after the intervention. Numeric rating scale ranges from 0 (no pain) to 10 (worst pain).
Measured: Baseline, 1 month, 3 months, 6 months
Secondary outcomes (1)
Change in WOMAC score from baseline
Participants' function as measured by WOMAC will be measured prior to the intervention and at 1 month, 3 months, and 6 months after the intervention. WOMAC score ranges from 0 (best) to 100 (worst).
Measured: Baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Nov 2021
- Primary completionAug 2023 (estimated)
- Study completionOct 2023 (estimated)
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 Kessler FoundationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul So, MD, Principal investigator, Kessler Institute for Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989660
- Sponsor's protocol ID
- R-1154-21
- Status last verified
- Mar 2022
- First submitted
- 27 Jul 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain
- ClinicalTrials.gov ID
- NCT04989660
- Acronym / sponsor ID
- R-1154-21
- Conditions
- Osteoarthritis, Knee, Knee Pain Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 4 Aug 2021 (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.
As the aging and obese populations continue to increase, there is a rapidly growing number of people at risk for knee osteoarthritis. Treatment typically starts conservatively with analgesics, physical therapy, and bracing. Intra-articular injections with corticosteroids and/or viscosupplementation may also be utilized in those with persistent knee pain. Genicular nerve radiofrequency ablation (GNRFA) is an increasingly employed procedure for refractory osteoarthritic knee pain with promising efficacy for pain relief. However, due to its reliance on expensive equipment, additional staff, and need for specialized rooms (eg. fluoroscopy suite), GNRFA is a costly procedure with limited availability. Chemical neurolysis is an alternative method of nerve ablation using alcohol or phenol utilized in the management of pain. Recent literature has demonstrated good efficacy for pain relief and function with chemical ablation of the genicular nerves using both alcohol and phenol.
This study is a double-blind, randomized, placebo-controlled pilot study to assess the efficacy of phenol neurolysis of the genicular nerves for pain and function due to refractory osteoarthritic knee pain. We hypothesize that a significant improvement in both pain and function will be observed with chemical neurolysis of the genicular nerves using 6% phenol compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: 6% aqueous phenol6% aqueous phenol, 1.5 mL per target site |
| Placebo Group | Placebo comparator | Drug: Isotonic salineIsotonic saline, 1.5 mL per target site |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Radiographic knee osteoarthritis (Kellgren-Lawrence grade 2-4)
- Knee pain of moderate intensity or greater (NRS of 4 or greater)
- Knee pain for 3 months or longer
- Persistent knee pain despite conservative treatment including oral/topical analgesics, physiotherapy, intra-articular injection with corticosteroid and/or hyaluronic acid
Key exclusion criteria (9 listed)
- Prior total or partial knee arthroplasty in the knee(s) to be treated
- Prior radiofrequency ablation treatment in the affected knee
- Other rheumatological or connective tissue disease(s) affecting the knee to be treated
- History of bleeding disorder
- Any psychiatric or neurologic disease (eg. dementia, brain injury, etc.) that may preclude reliable reporting of symptoms and response to treatment
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 |
|---|---|---|
| 6% aqueous phenolAlso: Phenol1.5 mL of 6% aqueous phenol will be injected at each target genicular nerve under ultrasound guidance. | Drug | Treatment Group |
| Isotonic saline1.5 mL of isotonic saline will be injected at each target genicular nerve under ultrasound guidance. | Drug | Placebo Group |
Primary outcome
Change in NRS pain score from baseline
Time frame: Baseline, 1 month, 3 months, 6 months
Participants' pain will be measured using the numeric rating scale (0-10) prior to the intervention and at 1 month, 3 months, and 6 months after the intervention. Numeric rating scale ranges from 0 (no pain) to 10 (worst pain).
1 secondary outcome
Change in WOMAC score from baseline
Time frame: Baseline, 1 month, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Paul So, MD principal investigator
Kessler Institute for Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 6% aqueous phenol and Isotonic saline in people with Osteoarthritis, Knee and Knee Pain Chronic, run by Kessler Foundation 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 4 inclusion and 9 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 31 Mar 2022. 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.
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 Paul So, MD (973-972-3606, ibaool@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NRS pain score from baseline (time frame: Baseline, 1 month, 3 months, 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 31 Mar 2022.