CClinicalTrials.gg
CompletedNCT06637046Updated Oct 15, 2024

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

An interventional study of Diagnostic procedures and Lidocaine HCl in Drop Foot, sponsored by Stephen Barrett. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Stephen Barrett · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 years 6 months after the study started (first participant enrolled Mar 2020, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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
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.

02

Conditions studied

  • Drop Foot

Keywords

  • Drop Foot
  • Common Peroneal Nerve Palsy
  • Weakness of Anterior and Lateral Compartment of Leg
03

In context

Lead sponsor

This is the only study on the registry with Stephen Barrett as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

-

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Lidocaine group

    Patients randomized to this arm received less than a .5cc infiltration of plain lidocaine

    Diagnostic Test: Diagnostic procedures · Diagnostic Test: Lidocaine HCl

  • Experimental
    Papavarine

    Patients randomized to this arm received less than a .5cc infiltration of 10mg/ml papaverine

    Diagnostic Test: Diagnostic procedures · Diagnostic Test: Lidocaine HCl

Interventions

  • Diagnostic testDiagnostic procedures

    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.

  • Diagnostic testLidocaine HCl

    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).

    Also known as: Papaverine

06

What researchers measure

Primary outcomes

  1. 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.

    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

07

Study locations

1 site
  • US Neuropathy Centers
    Marietta, Georgia 30067, United States
08

References and documents

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 30704688 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06637046
Lead sponsor
Stephen Barrett
Collaborators
US Neuropathy Centers
Responsible party
Stephen Barrett (CEO US Neuropathy Centers Medical Director, US Neuropathy Centers) — Sponsor-investigator
First posted
Oct 15, 2024
Start date
Mar 15, 2020
Primary completion
Feb 15, 2022
Completion
Nov 1, 2023
Last update
Oct 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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