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                                                             Veins and Lymphatics 2016; volume 5:5994

                                       [Veins and Lymphatics 2016; 5:5994]                                                         [page 27]

Adjustable topical compression
foot wrap, is more effective
than a dopamine agonist,
ropinirole, in reducing the
symptoms of moderate to
severe restless leg syndrome
Dean Bender,1 Phyllis J. Kuhn,1
Daniel J. Olson,2 John P. Sullivan3
1Lake Erie Research Institute, Inc., Girard,
PA; 2BayCity Associates in Podiatry, Inc.,
Erie, PA; 3Neurology Associates of Erie,
Erie, PA, USA

The objective was to measure the reduction
of symptoms with an adjustable topical com-
pression device (RESTIFFICTM Brand Pressure
Application System; Lake Erie Research
Institute, Inc., Girard, PA, USA) of the foot in
patients suffering with moderate to severe
Willis-Ekbom disease [restless leg syndrome
(RLS)].
We designed an experimental study: a single

arm, open label single center clinical trial with
a repeated measures design conducted from
April 2009 to August 2012. Follow-up averaged
1.3 years.

Forty-seven patients were enrolled, 11 were
excluded, 7 withdrew, one with usable results.
30 otherwise healthy adults, 22 women and 8
men, mean age 51.5 years, (range 30 to 75
years) diagnosed with moderate to severe pri-
mary RLS met eligibility criteria. Each patient
was provided a pair of the RESTIFFICTM devices
that applies targeted compression to the
abductor hallucis and the flexor hallucis brevis
muscles in the foot when worn during rest and
sleep. Main measure, patient-generated
International RLS study group (IRLSS) rating
scale; secondary measure, physician-generat-
ed clinical global impression (CGI) scale.
Patients were surveyed at period 1: baseline
(no device) Day 1-7, 3 times per period; period
2: with device Days 8-28, 8 times per period;
period 3: without device Days 29-35, 3 times
per period; period 4: with device Days 36-56, 8
times per period. Meta-analysis used to com-
pare RESTIFFICTM to historic reports of ropini-
role and placebo pill. Demographics, disease
severity assessment tools are similar among
studies.
RESTIFFICTM IRLSS score decreased from

25.05±5.33 (a mean baseline on the Day 1) to
7.83±6.33 (a mean score on Day 56), overall
reduction of 17.22±6.16 (P=0.0001) represent-
ing two levels of improvement from severe to

mild.  Change in mean IRLSS scores were sig-
nificantly greater for RESTIFFICTM, 17.22, com-
pared with historic reports of ropinirole, 12,
and its placebo, 8.9 (P<0.05).
CGI responders were significantly increased

for RESTIFFICTM, 90% (27/30), compared with
ropinirole 63% (293/464) (P<0.05). Only mini-
mal, transient side effects were reported that
were relieved by loosening the straps.
RESTIFFICTM was 1.44 times as effective as

historically reported ropinirole in reducing
IRLSS scores. RESTIFFICTM represented a
marked improvement over current pharmaceu-
tical solutions in both efficacy and safety. 

Correspondence: Dean Bender, Lake Erie
Research Institute, Inc., 8770 Brooks Road,
Girard, PA 16417, USA. 
E-mail: dbender@mediusa.com

This work is licensed under a Creative Commons
Attribution 4.0 License (by-nc 4.0).

©Copyright D. Bender et al., 2016
Licensee PAGEPress, Italy
Veins and Lymphatics 2016; 5:5994
doi:10.4081/vl.2016.5994

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