Drop Foot
Conditions
Keywords
Drop Foot, Nerve Blocks
Brief summary
To determine if the Phoenix sign can be reliably elicited with non-guided subcutaneous infiltration of D5W (5% Dextrose in Water) in patients with subclinical weakness of the extensor hallucis longus (EHL) muscle.
Detailed description
* To determine the prevalence of subclinical EHL weakness in a general clinical population * To measure the time course of strength changes following D5W infiltration * To identify potential predictive factors for positive response to treatment
Interventions
DRUGInfiltration of D5W
There is no other intervention.
Sponsors
US Neuropathy Centers
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
To test the hypothesis that the phoenix sign can be elicited with non-guided subcutaneous infiltration of D5W 20 Clinics/research sites with 30 consecutive patients would then account for 600 patients. Each clinic/researcher will evaluate 30 consecutive patients regardless of what pathology they are presenting to the clinic with, for EHL strength bilaterally. This compilation would then allow for a calculation of how many (what percentage) of them actually had a subclinical weakness. If there is a 10% incidence of subclinical weakness, then 60 patients would be enrolled in the study for evaluation of the effect of non-guided subcutaneous infiltration of D5W. Every patient that has documented weakness based on simple muscle grading of the EHL in this group would then ideally be enrolled into the clinical study.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* subjects must have a weakness of dorsiflexion and specifically of the Extensor Hallucis Longus muscle * drop foot
Exclusion criteria
* Trypanaphobia * allergy to D5W
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in motor strength of dorsiflexion of the anterior and lateral compartments of the lower extremity | From enrollment to end of their treatment at 1 day | Each subject will receive the infiltration and then be assessed for any changes in motor strength at 4 and 10 minutes after the injection. |
| Presence of absence of increase in motor strength of the lower extremity in dorsiflexion | From enrollment to the end of the day | Using manual motor testing the strength of the lower extremity in dorsiflexion will be evaluated with a score of 1-5 out of 5. |
| Number of subjects that have increased dorsiflexion strength after D5W infiltration | Enrollment to end of clinic vist in 1 hour | Subjects will be evaluated by manual motor testing of the patient before and after infiltration of D5W on a 1 to 5 out of 5 mother strength grading. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephen L Barrett, DPM MBA
US Neuropathy Centers LLC
Outcome results
None listed