NCT06637046

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

October 7, 2024

Last Update Submit

October 9, 2024

Conditions

Drop Foot

Keywords

Drop FootCommon Peroneal Nerve PalsyWeakness of Anterior and Lateral Compartment of Leg

Outcome Measures

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.

    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

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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

Diagnostic Test: Diagnostic proceduresDiagnostic Test: Lidocaine HCl

Papavarine

EXPERIMENTAL

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

Diagnostic Test: Diagnostic proceduresDiagnostic Test: Lidocaine HCl

Interventions

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 groupPapavarine
Lidocaine HClDIAGNOSTIC_TEST

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
Lidocaine groupPapavarine

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Neuropathy Centers

Marietta, Georgia, 30067, United States

Location

Related Publications (2)

  • 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.

    PMID: 30704688BACKGROUND

  • Barrett 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.

    PMID: 39443927DERIVED

MeSH Terms

Conditions

Peroneal Neuropathies

Interventions

Diagnostic Techniques and Procedures

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
CEO US Neuropathy Centers Medical Director

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 15, 2024

Study Start

March 15, 2020

Primary Completion

February 15, 2022

Study Completion

November 1, 2023

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)