Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infiltration of D5W | Experimental | 3 cc's of D5W will be infiltrated subcutaneously at the level of the fibular neck to see if there is any improvement in dorsiflexion strength at 4 and 10 minutes post infiltration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infiltration of D5W | Drug | There is no other intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in motor strength of dorsiflexion of the anterior and lateral compartments of the lower extremity | Each subject will receive the infiltration and then be assessed for any changes in motor strength at 4 and 10 minutes after the injection. | From enrollment to end of their treatment at 1 day |
| Presence of absence of increase in motor strength of the lower extremity in dorsiflexion | Using manual motor testing the strength of the lower extremity in dorsiflexion will be evaluated with a score of 1-5 out of 5. | From enrollment to the end of the day |
| Number of subjects that have increased dorsiflexion strength after D5W infiltration | 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. | Enrollment to end of clinic vist in 1 hour |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen L Barrett, DPM MBA | US Neuropathy Centers LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Neuropathy Centers | Marietta | Georgia | 30067 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020427 | Peroneal Neuropathies |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided