6-month visits: plantar surface of
the distal great toe, the distal 3rd toe,
the distal 5th toe, the 1st metatarsal
head, the 3rd metatarsal head, the
5th metatarsal head, and the mid-plantar arch. At each site, the SWM
was applied with just enough force
to initiate a bending force and held
for 1.5 seconds. Each site was tested
3 times. Participants had to detect
the monofilament at least twice for
the monofilament value to be recorded. Monofilament testing began
with 6. 65 SWM and decreased to
5.07, 4. 56, 4. 32, and lower until the
patient was no longer able to detect
The Tinetti Gait and Balance Assessments was performed on each
participant at the initial, 12th,
3-month, and 6-month visits. Tinetti
balance, gait, and total scores were
recorded at each interval.
Thirty-three patients, referred by primary care providers and specialty
clinics, met the inclusion criteria
and enrolled in the study. Twenty-one patients ( 20 men and 1 woman)
completed the entire 6-month study.
Causes for withdrawal included
travel difficulties ( 5), did not show
up for follow-up visits ( 4), lumbar radiculopathy (1), perceived minimal/
no benefit (1), and unrelated death
(1). No AEs were reported.
The Friedman test with DMC post
hoc test was performed on the POQ-
VA total score and subscale scores.
The POQ-VA subscale scores were
divided into the following domains:
pain, activities of daily living (ADL),
fear, negative affect, mobility, and
vitality. The POQ-VA domains were
analyzed to compare data from the
initial, 12th, 3-month, and 6-month
visits. The POQ-VA total score sig-
nificantly decreased from the initial
to the 12th visit (P < .01), from the
initial to the 3-month (P < .01), and
from the initial to the 6-month visit
(P < .05). However, there was no sig-
nificant change from the 12th visit
to the 3-month follow-up, 12th visit
to the 6-month follow-up, or the
3-month to 6-month follow-up.
The POQ-VA pain score decreased
significantly from the initial to the
12th visit (P < .05) and from the ini-
tial to the 6-month visit (P < .05).
However, there was no significant in-
terval change from the initial to the
3-month, the 12th to 3-month, 12th
to 6-month, or 3-month to 6-month
visit (Figure 1). The POQ-VA vital-
ity scores and POQ-VA fear scores
did not yield significant changes.
The POQ-VA negative affect scores
showed significant improvement
only between the initial and the
3-month visit (P < .05) (Figure 2).
The POQ-VA ADL scores showed
significant improvement in the ini-
tial vs 3-month score (P < .05). The
POQ-VA mobility scores were signifi-
cantly improved for the initial vs 12th
visit (P < .01), initial vs 3-month visit
(P < .01), and the initial vs 6-month
visit (P < .001) (Figure 1).
Analysis of VAS scores revealed a
significant decrease at the 6-month
time frame compared with the ini-
tial score for the left foot (P < .05).
Further VAS analysis revealed no
significant difference between the
initial and 6-month right foot VAS
score. When both feet were com-
pared together, there was no sig-
nificant difference in VAS ratings
between any 2 points in time.
Analysis of Tinetti Total Score, Ti-
netti Balance Score, and Tinetti Gait
Score revealed a significant difference
between the initial vs 3-month visit
for all 3 scores (P < .001, P < .001,
and P < .05, respectively). In addi-
tion, Tinetti Total (P < .001) and
Tinetti Balance (P < .01) scores
were significantly improved from
initial to the final 6-month visit.
There were no significant findings
between interim scores of the ini-
tial and 12th visits, the 12th and
3-month visits, or the 3-month and
6-month scores (Figure 2).
Analysis of SWM testing indi-
cated a significant decrease in the
total number of insensate sites
(> 5.07) when both feet were grouped
together between the initial and
3-month visits (P < .05) as well as
the initial and 6-month (P < .01) vis-
its. When the left and right feet were
Figure 2. Tinetti Gait and Balance Assesment
Balance Gait Total