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
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:
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.
This is the only study on the registry with Stephen Barrett as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria: Patients with normal motor strength of the anterior compartment of the leg.
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Patients randomized to this arm received less than a .5cc infiltration of plain lidocaine
Diagnostic Test: Diagnostic procedures · Diagnostic Test: Lidocaine HCl
Patients randomized to this arm received less than a .5cc infiltration of 10mg/ml papaverine
Diagnostic Test: Diagnostic procedures · Diagnostic Test: Lidocaine HCl
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.
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
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
Plan to share: No
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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