Drop FootNCT06637046
Does Blood Vessel Vasodilation, Caused by Focal Infiltration of Lidocaine Cause Temporary Nerve Functional Recovery for Patients with Common Peroneal Nerve Injury or Entrapment: Testing the 'Phoenix Sign' Effect Between Lidocaine (a Common Local Anesthetic) and Papaverine, a Know Vasodilator
A study testing Diagnostic procedures and Lidocaine HCl in people with Drop Foot, run by Stephen Barrett at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare lidocaine without epinephrine to papaverine a known vasodilatory agent, in creating improved motor strength in patients with drop foot involving an entrapment of the Common Peroneal Nerve. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Drop Foot
- What is being tested?
- Diagnostic procedures and Lidocaine HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2020to 1 Nov 2023
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Cohort inclusion criteria also included a stable medical and medication status, ages 18-85, speaking English as the primary language, and ambulatory. Walking aids or ankle-foot orthosis were permitted.
-
Exclusion Criteria: Patients with normal motor strength of the anterior compartment of the leg.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Phoenix Sign Phenomenon Due to Vasodilation? a Double-Blinded, Randomized Controlled Trial Comparing Motor Function Recovery After Diagnostic Common Fibular Nerve Block with Lidocaine and Papaverine
The goal of this clinical trial is to compare lidocaine without epinephrine to papaverine a known vasodilatory agent, in creating improved motor strength in patients with drop foot involving an entrapment of the Common Peroneal Nerve. This phenomenon has been named the Phoenix Sign and is a very specific peripheral nerve block.
Researchers will compare the effects of the above agent for pre and post infiltration changes in motor strength.
Read more
Participants will:
- Will be randomized to one of either agents already listed
- After receiving the ultrasound guided injection, motor testing will be evaluated in 4-6 minutes with manual motor strength testing of the anterior compartment muscles.
- No additional follow will be required
Read the detailed description
A double-blinded, randomised, prospective controlled trial was conducted at US Neuropathy Centers in Marietta, GA, under the approval of the Kennesaw State University Institutional Review Board. Patients with weak dorsiflexion of the ankle or a drop foot were recruited from the existing clinical practice at US Neuropathy Centers. Cohort inclusion criteria also included a stable medical and medication status, ages 18-85, speaking English as the primary language, and ambulatory. Walking aids or ankle-foot orthosis were permitted.. Based on the inclusion criteria, only 20 patients were enrolled. Patients were recruited over a period of 1 year and two months from January 2021 to March 2022 with no requirement for follow-up. The enrolment phase was concluded as the study was originally designed as a pilot investigation, with recruitment limited to a single, small medical practice. A total of 20 patients were successfully enrolled within this setting.Participants were randomised by the throw of dice to injection of 0.3 cc of Papaverine HCl 10 mg/mL or 0.3 cc of 1% Lidocaine HCl adjacent to CFN in a room separate from patient room. Injection solutions were prepared by non-blinded assistants and were visually indistinguishable. Patients and physicians are blinded to drugs received. Motor strength of the Extensor Hallucis Longus (EHL), Tibialis Anterior (TA), and Extensor Digitorum Longus (EDL) muscles were tested. Strength was rated according to the Medical Research Council Manual Muscle Testing scale 0-5. The CFN at the fibular neck was identified under high-resolution ultrasound imaging. The injection site was prepared with alcohol, and ethyl chloride was used to anaesthetise the skin. A 30-gauge 1-inch needle was inserted adjacent to, but not within, the CFN. The infiltrate was delivered at the level of the fibular neck just proximal to where the CPN coursed beneath the deep fascia of the peroneus longus. This was immediately adjacent to the first known anatomical site of compression of the CPN. 0.3cc of the drug was delivered.
The investigator then waited approximately five minutes and re-tested motor strength of the Extensor Hallucis Longus (EHL), Tibialis Anterior (TA), and Extensor Digitorum Longus (EDL) muscles manually.
- Conditions
- Drop Foot
- Being tested
- Diagnostic procedures, Lidocaine HCl
- Keywords
- Drop Foot, Common Peroneal Nerve Palsy, Weakness of Anterior and Lateral Compartment of Leg
- Medical subject headings
- Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic proceduresDiagnostic test
A 30-gauge 1-inch needle was inserted adjacent to, but not within, the CFN. The infiltrate was delivered at the level of the fibular neck just proximal to where the CPN coursed beneath the deep fascia of the peroneus longus. This was immediately adjacent to the first known anatomical site of compression of the CPN. 0.3cc of the drug was delivered.
Lidocaine HClDiagnostic test
Also called Papaverine
This study compares the vasodilatory effects of lidocaine to papaverine after diagnostic infiltration of the Common Peroneal Nerve in patients with demonstrated motor weakness of the EHL (extensor hallucis longus).
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Experimental | Patients randomized to this arm received less than a .5cc infiltration of plain lidocaine Receives: Diagnostic Test: Diagnostic procedures; Diagnostic Test: Lidocaine HCl |
| Papavarine | Experimental | Patients randomized to this arm received less than a .5cc infiltration of 10mg/ml papaverine Receives: Diagnostic Test: Diagnostic procedures; Diagnostic Test: Lidocaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Motor Strength Testing of Anterior Compartment
Motor strength of the Extensor Hallucis Longus (EHL), Tibialis Anterior (TA), and Extensor Digitorum Longus (EDL) muscles were tested. Strength was rated according to the Medical Research Council Manual Muscle Testing scale 0-5.
Measured: From enrollment to evaluation which is complete upon the first study visit after infiltration of the agents. The increased motor effect after infiltration is only apparent for 10 minutes or less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Mar 2020
- Primary completion15 Feb 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drop FootStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen Barrett
- Sponsor type
- University, hospital or other
- Collaborators
- US Neuropathy Centers
- Responsible party
- Sponsor-investigator, Stephen Barrett, US Neuropathy Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637046
- Sponsor's protocol ID
- Study 20-391
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bowley MP, Doughty CT. Entrapment Neuropathies of the Lower Extremity. Med Clin North Am. 2019 Mar;103(2):371-382. doi: 10.1016/j.mcna.2018.10.013. Epub 2018 Dec 3.
PubMed 30704688Barrett SL, Boyd B, DuCasse S, Nassier W, Mitchell N, Nagra AP, Dalmau-Pastor M, Yamasaki DS, Nickerson S. Is the phoenix sign phenomenon due to vasodilation? A double-blinded, randomized controlled trial comparing motor function recovery after diagnostic common fibular nerve block with lidocaine and papaverine. BMC Musculoskelet Disord. 2024 Oct 23;25(1):840. doi: 10.1186/s12891-024-07972-3.
PubMed 39443927
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Phoenix Sign Phenomenon Due to Vasodilation? a Double-Blinded, Randomized Controlled Trial Comparing Motor Function Recovery After Diagnostic Common Fibular Nerve Block with Lidocaine and Papaverine
- ClinicalTrials.gov ID
- NCT06637046
- Acronym / sponsor ID
- Study 20-391
- Conditions
- Drop Foot
- Keywords
- Drop Foot, Common Peroneal Nerve Palsy, Weakness of Anterior and Lateral Compartment of Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stephen BarrettUniversity, hospital or other
- Collaborators
- US Neuropathy Centers
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 15 Oct 2024 (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.
The goal of this clinical trial is to compare lidocaine without epinephrine to papaverine a known vasodilatory agent, in creating improved motor strength in patients with drop foot involving an entrapment of the Common Peroneal Nerve. This phenomenon has been named the Phoenix Sign and is a very specific peripheral nerve block.
Researchers will compare the effects of the above agent for pre and post infiltration changes in motor strength.
Participants will:
- Will be randomized to one of either agents already listed
- After receiving the ultrasound guided injection, motor testing will be evaluated in 4-6 minutes with manual motor strength testing of the anterior compartment muscles.
- No additional follow will be required
Detailed description
A double-blinded, randomised, prospective controlled trial was conducted at US Neuropathy Centers in Marietta, GA, under the approval of the Kennesaw State University Institutional Review Board. Patients with weak dorsiflexion of the ankle or a drop foot were recruited from the existing clinical practice at US Neuropathy Centers. Cohort inclusion criteria also included a stable medical and medication status, ages 18-85, speaking English as the primary language, and ambulatory. Walking aids or ankle-foot orthosis were permitted.. Based on the inclusion criteria, only 20 patients were enrolled. Patients were recruited over a period of 1 year and two months from January 2021 to March 2022 with no requirement for follow-up. The enrolment phase was concluded as the study was originally designed as a pilot investigation, with recruitment limited to a single, small medical practice. A total of 20 patients were successfully enrolled within this setting.Participants were randomised by the throw of dice to injection of 0.3 cc of Papaverine HCl 10 mg/mL or 0.3 cc of 1% Lidocaine HCl adjacent to CFN in a room separate from patient room. Injection solutions were prepared by non-blinded assistants and were visually indistinguishable. Patients and physicians are blinded to drugs received. Motor strength of the Extensor Hallucis Longus (EHL), Tibialis Anterior (TA), and Extensor Digitorum Longus (EDL) muscles were tested. Strength was rated according to the Medical Research Council Manual Muscle Testing scale 0-5. The CFN at the fibular neck was identified under high-resolution ultrasound imaging. The injection site was prepared with alcohol, and ethyl chloride was used to anaesthetise the skin. A 30-gauge 1-inch needle was inserted adjacent to, but not within, the CFN. The infiltrate was delivered at the level of the fibular neck just proximal to where the CPN coursed beneath the deep fascia of the peroneus longus. This was immediately adjacent to the first known anatomical site of compression of the CPN. 0.3cc of the drug was delivered.
The investigator then waited approximately five minutes and re-tested motor strength of the Extensor Hallucis Longus (EHL), Tibialis Anterior (TA), and Extensor Digitorum Longus (EDL) muscles manually.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Diagnostic Test: Diagnostic procedures, Diagnostic Test: Lidocaine HClPatients randomized to this arm received less than a .5cc infiltration of plain lidocaine |
| Papavarine | Experimental | Diagnostic Test: Diagnostic procedures, Diagnostic Test: Lidocaine HClPatients randomized to this arm received less than a .5cc infiltration of 10mg/ml papaverine |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Diagnostic proceduresA 30-gauge 1-inch needle was inserted adjacent to, but not within, the CFN. The infiltrate was delivered at the level of the fibular neck just proximal to where the CPN coursed beneath the deep fascia of the peroneus longus. This was immediately adjacent to the first known anatomical site of compression of the CPN. 0.3cc of the drug was delivered. | Diagnostic test | Lidocaine group, Papavarine |
| Lidocaine HClAlso: PapaverineThis study compares the vasodilatory effects of lidocaine to papaverine after diagnostic infiltration of the Common Peroneal Nerve in patients with demonstrated motor weakness of the EHL (extensor hallucis longus). | Diagnostic test | Lidocaine group, Papavarine |
Primary outcome
Manual Motor Strength Testing of Anterior Compartment
Time frame: From enrollment to evaluation which is complete upon the first study visit after infiltration of the agents. The increased motor effect after infiltration is only apparent for 10 minutes or less
Motor strength of the Extensor Hallucis Longus (EHL), Tibialis Anterior (TA), and Extensor Digitorum Longus (EDL) muscles were tested. Strength was rated according to the Medical Research Council Manual Muscle Testing scale 0-5.
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 15 Oct 2024.
- Background: PubMed 30704688Bowley MP, Doughty CT. Entrapment Neuropathies of the Lower Extremity. Med Clin North Am. 2019 Mar;103(2):371-382. doi: 10.1016/j.mcna.2018.10.013. Epub 2018 Dec 3.
- Derived from this study: PubMed 39443927Barrett SL, Boyd B, DuCasse S, Nassier W, Mitchell N, Nagra AP, Dalmau-Pastor M, Yamasaki DS, Nickerson S. Is the phoenix sign phenomenon due to vasodilation? A double-blinded, randomized controlled trial comparing motor function recovery after diagnostic common fibular nerve block with lidocaine and papaverine. BMC Musculoskelet Disord. 2024 Oct 23;25(1):840. doi: 10.1186/s12891-024-07972-3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic procedures and Lidocaine HCl in people with Drop Foot, run by Stephen Barrett 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?
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 15 Oct 2024. 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?
Manual Motor Strength Testing of Anterior Compartment (time frame: From enrollment to evaluation which is complete upon the first study visit after infiltration of the agents. The increased motor effect after infiltration is only apparent for 10 minutes or less). 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 NCT06637046, which also lists 2 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 15 Oct 2024.