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Program Profile

A Combined Treatment Protocol


for Patients With Diabetic
Peripheral Neuropathy
Wendy M. Flerx, MS, PT; Meredith R. Hall, DPT

A physical therapy approach using monochromatic infrared energy and a


balance program was shown to be effective in significantly reducing fall risk,
reversing the loss of protective sensation, and improving functional ability.

T
he progressive symptoms of tified to be at risk for limb loss in BACKGROUND
diabetic peripheral neuropa- 2014 due to loss of protective sensa- Current treatments for DPN are pri-
thy (DPN) are some of the tion and 5,667 veterans diagnosed marily pharmacologic and are viewed
most frequent presentations with DPN were treated in 2014.4 Al- as only moderately effective, limited
of patients seeking care at the VHA. though WJBDVAMC offers multiple by significant adverse effects (AEs)
Patients with DPN often experience clinics and programs to address the and drug interactions. 5 Patients
unmanageable pain in the lower complex issues of diabetes and DPN, in the VHA at risk for amputation
extremities, loss of sensation in the veterans oftentimes continue to ex- in low-, moderate-, and high-risk
feet, loss of balance, and an inabil- perience uncontrolled pain, loss of groups total 541,475 and 363,468
ity to perform daily functional ac- protective sensation, and a decline in have a history of neuropathy. They
tivities.1 In addition, these patients function even after diagnosis. are considered at risk due to multi-
are at significant risk for lower ex- One area of improvement the au- ple, documented factors, including
tremity ulceration and amputation.2 thors identified in the WJBDVAMC weakness, callus, foot deformity, loss
The symptoms and consequences of Physical Medicine and Rehabilitation of protective sensation, and/or his-
DPN are strongly linked to chronic Services Department was the need tory of amputation.4 Neuropathy can
use of pain medications as well as for an effective, nonpharmacologic affect tissues throughout the body,
increased fall risk and injury.3 The treatment for patients who experi- including organs, sensory neurons,
high health care usage of veterans ence DPN. As a result, the authors cardiovascular status, the autonomic
with these complex issues makes designed a pilot research study to de- system, and the gastrointestinal tract
DPN a significant burden for the termine whether or not a combined as it progresses.
patient, the VHA, and society as a physical therapy intervention of Individuals who develop DPN
whole. monochromatic near-infrared energy often experience severe, uncontrolled
At the William Jennings (MIRE) treatments and a standard- pain in the lower extremities, insen-
Bryan Dorn VA Medical Center ized balance exercise program would sate feet, and decreased proprioceptive
(WJBDVAMC) in Columbia, South help improve the protective sensa- skills. The functional status of individ-
Carolina, 10,763 veterans were iden- tion, reduce fall risk, and decrease the uals with DPN often declines insidi-
adverse impact of pain on daily func- ously while mortality rate increases.6
Ms. Flerx is a pain clinical specialist and Dr. Hall tion. The study was approved by the Increased levels of neuropathic pain
is the supervisor of physical therapy, both in the
Physical Therapy Department at William Jennings institutional review board (IRB) and often lead to decreased activity lev-
Bryan Dorn VAMC in Columbia, South Carolina. had no outside source of funding. els, which, in turn, contribute to

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decreased endurance, poorly managed ally is not superior to a placebo.13 METHODS
glycemic indexes, decreased strength, However, a case study by Somers and This was a prospective, case se-
and decreased independence. Somers indicated that TENS applied ries pilot study designed to measure
Additional DPN complications, to the lumbar area seemed to reduce changes in patient pain levels using
such as decreased sensation and pain and insomnia associated with the visual analog scale (VAS) and Pain
muscle atrophy in the lower extremi- diabetic neuropathy.14 Outcomes Questionnaire-VA (POQ-
ties, often lead to foot deformity and Several recent research studies VA), degree of protective sensation
increased areas of pressure during suggest that MIRE, another available loss as measured by SWM, and fall
weight bearing postures. These areas modality, may be effective in treating risk as denoted by Tinetti scores from
of increased pressure may develop symptoms of DPN. Monochromatic entry to 6 months. Informed consent
unknowingly into ulceration. If a pa- infrared energy therapy is a noninva- was obtained prior to treatment, and
tient’s wound becomes chronic and sive, drug-free, FDA-approved medi- 33 patients referred by primary care
nonhealing, it can also lead to ampu- cal device that emits monochromatic providers and specialty clinics met
tation. In such cases, early mortality near-infrared light to improve local the criteria and enrolled in the study.
may result.6,7 The cascading effects of circulation and decrease pain. A large Twenty-one patients completed the
neuropathic pain and decreased sen- study of 2,239 patients with DPN re- entire 6-month study. The nonpara-
sation place a patient with diabetes ported an increase in foot sensation metric Friedman test with a Dunn’s
at risk for falls. Injuries from falls are and decreased neuropathic pain levels multiple comparison (DMC) post
widely known to be a leading cause when treated with MIRE.15 hoc test was used to analyze the data
of hospitalization and mortality in Leonard and colleagues found from the initial, 4-week, 3-month, and
the elderly.8 that the MIRE treatments resulted in 6-month follow-up visits.
Physical therapy may be pre- a significant increase in sensation in
scribed for DPN and its resulting individuals with baseline sensation Setting and Participants
sequelae. Several studies present of 6.65 Semmes-Weinstein Mono- The study was performed in the Out-
conflicting results regarding the filament (SWM) after 6 and 12 ac- patient Physical Therapy Department
benefits of therapeutic exercise in tive treatments as well as a decrease at WJBDVAMC. Veterans with DPN
the treatment of DPN. Akbari and in neuropathic symptoms as mea- who met the inclusion/exclusion cri-
colleagues showed that balance ex- sured by the Michigan Neuropathy teria were enrolled. Inclusion criteria
ercises can increase stability in pa- Screening Instrument.16 Prendergast specified that the participant must
tients with DPN; whereas, a study and colleagues noted improved elec- be referred by a qualified health care
by Kruse and colleagues noted a trophysical changes in both large provider for the treatment of DPN,
training program consisting of lower- and small myelinated nerve fibers be able to read and write in English,
extremity exercises, balance training, of patients with DPN following 10 have consistent transportation to and
and walking resulted in minimal im- MIRE treatments. 17 When study- from the study location, and be able
provement of participants’ balance ing 49 patients with DPN, Kochman to apply MIRE therapy as directed at
and leg strength over a 12-month pe- and colleagues found 100% of par- home.
riod.9,10 Recent studies have shown ticipants had improved sensation after Exclusion criteria were sub-
that weight bearing does not increase 12 MIRE treatments when tested with jects for whom MIRE or exercise
ulceration in patients with diabetes monofilaments.18 were contraindicated. Subjects were
and DPN. This is contrary to previ- An additional benefit of MIRE excluded if they had medical con-
ous assumptions that patients with treatment is that it can be safely per- ditions that suggested a possible de-
diabetes and DPN need to avoid formed at home once the patient is cline in health status in the next 6
weight-bearing activities.11,12 educated on proper use and appli- months. Such conditions included
Transcutaneous electrical nerve cation. Home DPN treatment has a current regimen of chemotherapy,
stimulation (TENS), a modality often the potential to decrease the burden radiation therapy, or dialysis; recent
used in physical therapy, has been this population places on health care lower extremity amputation without
studied in the treatment of DPN with systems by reducing provider visits, prosthesis; documented active alco-
conflicting results. Gossrau and col- medication, hospitalization second- hol and/or drug misuse; advanced
leagues found that pain reduction ary to pain, ulceration, fall injuries, chronic obstructive pulmonary dis-
with micro-TENS applied peripher- and amputations. ease as defined as dyspnea at rest at

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Diabetic Peripheral Neuropathy

Figure 1. Pain Outcome Questionnaire-VA Subscores


30
Initial visit
12th visit
25
3-mo visit
6-mo visit
Scores (mean ± SEM)

20

15

10

0
Pain Mobility ADL Vitality NA Fear

Abbreviations: ADL, activities of daily living; NA, negative affect.

least once per day; unstable angina; cise program for balance. raises, bilateral toe raises, unilateral
hemiplegia or other lower extrem- In the clinic, 2 pads from the heel raises, unilateral toe raises, par-
ity paralysis; and a history of central MIRE device (Anodyne Therapy, tial wall squats, and single leg stance.
nervous system or peripheral nervous LLC, Tampa, FL) were placed along Each participant performed these ex-
system demyelinating disorders. Ad- the medial and lateral aspect of ercises 3 times per week in the clinic
ditional exclusion criteria included each lower leg, and an additional 2 and then 3 times per week at home
hospitalization in the past 60 days, pads were placed in a T formation following the 12th visit.
use of any apparatus for continuous on the plantar surface of each foot,
or patient-controlled analgesia; his- per the manufacturer’s recommen- Outcomes and Follow-up
tory of chronic low back pain with dations. The T formation consisted The POQ-VA, a subjective quality of
documented radiculopathy; and any of the first pad placed horizontally life (QOL) measure for veterans, as
change in pertinent medications in the across the metatarsal heads and the well as VAS, SWM testing, and the
past 60 days, including pain medica- second placed vertically down the Tinetti Gait and Balance Assessment
tions, insulin, metformin, and anti- length of the foot. Each pad was scores were used to measure out-
inflammatories. protected by plastic wrap to ensure comes. Data were collected for each
proper hygiene and secured. The in- of these measures during the ini-
Interventions tensity of clinic treatments was set at tial and 12th clinic visits and at the
Subjects participated in a combined 7 bars, which minimized the risk of 3-month and 6-month follow-up
physical therapy approach using burns. Home treatments were simi- visits. The POQ-VA and VAS scores
MIRE and a standardized balance lar to those in the clinic, except that were self-reported and filled out by
program. Patients received treatment each leg had to be treated individually each participant at the initial, 12th,
in the outpatient clinic 3 times each instead of simultaneously and home 3-month, and 6-month visits. The
week for 4 weeks. The treatment MIRE units are preset and only func- POQ-VA score has proven to be reli-
then continued at the same frequency tion at an intensity that is equivalent able and valid for the assessment of
at home until the scheduled 6-month to around 7 bars on the clinical unit. noncancer, chronic pain in veterans.19
follow-up visit. Clinic and home The standardized balance pro- The VAS scores were measured using
treatments included application of gram consisted of a progression of a scale of 0 to 10 cm.
MIRE to bilateral lower extremities the following exercises: ankle alpha- The SWM was standardized, and
and feet for 30 minutes each as well bet/ankle range of motion, standing 7 sites were tested on each foot dur-
as performance of a therapeutic exer- lateral weight shifts, bilateral heel ing the initial, 12th, 3-month, and

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Diabetic Peripheral Neuropathy

6-month visits: plantar surface of


Figure 2. Tinetti Gait and Balance Assesment
the distal great toe, the distal 3rd toe,
the distal 5th toe, the 1st metatarsal Initial visit
head, the 3rd metatarsal head, the 25
12th visit
5th metatarsal head, and the mid-
3-mo visit
plantar arch. At each site, the SWM
20 6-mo visit
was applied with just enough force
to initiate a bending force and held
15
Tinetti Score
for 1.5 seconds. Each site was tested
3 times. Participants had to detect
the monofilament at least twice for 10
the monofilament value to be re-
corded. Monofilament testing began
with 6.65 SWM and decreased to 5
5.07, 4.56, 4.32, and lower until the
patient was no longer able to detect 0
sensation. Balance Gait Total
The Tinetti Gait and Balance As-
sessments was performed on each initial to the 3-month (P < .01), and time frame compared with the ini-
participant at the initial, 12th, from the initial to the 6-month visit tial score for the left foot (P < .05).
3-month, and 6-month visits. Tinetti (P < .05). However, there was no sig- Further VAS analysis revealed no
balance, gait, and total scores were nificant change from the 12th visit significant difference between the
recorded at each interval. to the 3-month follow-up, 12th visit initial and 6-month right foot VAS
to the 6-month follow-up, or the score. When both feet were com-
RESULTS 3-month to 6-month follow-up. pared together, there was no sig-
Thirty-three patients, referred by pri- The POQ-VA pain score decreased nificant difference in VAS ratings
mary care providers and specialty significantly from the initial to the between any 2 points in time.
clinics, met the inclusion criteria 12th visit (P < .05) and from the ini- Analysis of Tinetti Total Score, Ti-
and enrolled in the study. Twenty- tial to the 6-month visit (P < .05). netti Balance Score, and Tinetti Gait
one patients (20 men and 1 woman) However, there was no significant in- Score revealed a significant difference
completed the entire 6-month study. terval change from the initial to the between the initial vs 3-month visit
Causes for withdrawal included 3-month, the 12th to 3-month, 12th for all 3 scores (P < .001, P < .001,
travel difficulties (5), did not show to 6-month, or 3-month to 6-month and P < .05, respectively). In addi-
up for follow-up visits (4), lumbar ra- visit (Figure 1). The POQ-VA vital- tion, Tinetti Total (P < .001) and
diculopathy (1), perceived minimal/ ity scores and POQ-VA fear scores Tinetti Balance (P < .01) scores
no benefit (1), and unrelated death did not yield significant changes. were significantly improved from
(1). No AEs were reported. The POQ-VA negative affect scores initial to the final 6-month visit.
The Friedman test with DMC post showed significant improvement There were no significant findings
hoc test was performed on the POQ- only between the initial and the between interim scores of the ini-
VA total score and subscale scores. 3-month visit (P < .05) (Figure 2). tial and 12th visits, the 12th and
The POQ-VA subscale scores were The POQ-VA ADL scores showed 3-month visits, or the 3-month and
divided into the following domains: significant improvement in the ini- 6-month scores (Figure 2).
pain, activities of daily living (ADL), tial vs 3-month score (P < .05). The Analysis of SWM testing indi-
fear, negative affect, mobility, and POQ-VA mobility scores were signifi- cated a significant decrease in the
vitality. The POQ-VA domains were cantly improved for the initial vs 12th total number of insensate sites
analyzed to compare data from the visit (P < .01), initial vs 3-month visit (> 5.07) when both feet were grouped
initial, 12th, 3-month, and 6-month (P < .01), and the initial vs 6-month together between the initial and
visits. The POQ-VA total score sig- visit (P < .001) (Figure 1). 3-month visits (P < .05) as well as
nificantly decreased from the initial Analysis of VAS scores revealed a the initial and 6-month (P < .01) vis-
to the 12th visit (P < .01), from the significant decrease at the 6-month its. When the left and right feet were

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Diabetic Peripheral Neuropathy

Figure 3. Semmes-Weinstein Monofilament Testing personal and financial impact of DPN.


It is interesting to note that some
25 Initial visit POQ-VA and Tinetti subscores were
significantly improved at 3 months
12th visit
but not at 6 months. The significance
No. of Sites > 5.07 (Mean ± SEM)

20 3-mo visit
achieved at 3 months may be due
6-mo visit
to the time required (ie, > 12 visits)
15 to make significant physiological
changes. The lack of significance at
6 months may be due to the natu-
10
ral tendency of participants to less
consistently perform the home ex-
5 ercise program and MIRE protocol
when unsupervised in the home.
0 Differences in the VAS and POQ-VA
Left Foot Right Foot Both Feet pain score ratings were noted in the
data. The POQ-VA pain rating scale
indicated significant improvement
compared independently of each gests that the combined treatment in pain levels over the course of the
other, there was a significant decrease protocol will help veterans main- study. However, when asked about
in the number of insensate sites be- tain an active lifestyle despite poorly pain using the 10-cm VAS, patients
tween the initial and 6-month visits controlled diabetes and neuropathic reported no significant improve-
(P < .01 for both) (Figure 3). pain. ments. This may be because veterans
Along with decreased pain in- are more familiar with the numerical
DISCUSSION terference with QOL, participants pain rating scale and are rarely asked
This study investigated whether or demonstrated a decrease in fall risk to use the 10-cm VAS. It may also be
not a multimodal physical therapy as quantified by the Tinetti Gait and because the POQ-VA pain rating asks
approach would reduce several of Balance Assessment. The SWM test- for an average pain level over the pre-
the debilitating symptoms of DPN ing showed improved protective vious week, whereas the 10-cm VAS
experienced by many veterans at sensation as early as 3 months and asks for pain level at a discrete point
WJBDVAMC. The results support the continued through the 6-month visit. in time.
idea that a combined treatment pro- As protective sensation improves and Historically, physical therapy has
tocol of MIRE and a standardized ex- fall risk decreases, the risk of injury is had little to offer individuals with
ercise program can lead to decreased lessened, fear of falling is decreased, DPN. As a result of this study, how-
POQ-VA pain levels, improved bal- and individuals are less likely to self- ever, a standardized treatment pro-
ance, and improved protective sensa- impose limitations on daily activity gram for DPN has been implemented
tion in veterans with DPN. Alleviation levels, which improves QOL. In addi- at the WJBDVAMC Physical Therapy
of these DPN complications may ulti- tion, decreased fall risk and improved Clinic. Referred patients are seen in
mately decrease an individual’s risk of protective sensation can reduce the the clinic on a trial basis. If positive
injury and improve overall QOL. financial burden on both the patient results are documented during the
Because the POQ-VA is a reliable, and the health care system. Many in- clinic treatments, a home MIRE unit
valid self-reported measure for vet- dividuals are hospitalized secondary and exercise program are provided.
erans, it was chosen to quantify the to fall injury, nonhealing wounds, The patients are expected to con-
impact of pain. Overall, veterans who resulting infections, and/or second- tinue performing home treatments
participated in this study perceived ary complications from prolonged of MIRE and exercise 3 times a week
decreased pain interference in mul- immobility. This treatment protocol after discharge.
tiple areas of their lives. The most demonstrates how a standardized
significant findings were in overall physical therapy protocol, including Strengths and Limitations
QOL, household and community MIRE and balance exercises, can be Strengths of the study include a
mobility, and pain ratings. This sug- used preventively to reduce both the stringent IRB review, control of

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Diabetic Peripheral Neuropathy

medication changes during the study by the devastating effects of diabetic Intranet. http://vssc.med.va.gov.
5. G ore M, Brandenburg NA, Hoffman DL, Tai KS,
through alerts to all VA providers, neuropathy. ● Stacey B. Burden of illness in painful diabetic pe-
and a standardized MIRE and exer- ripheral neuropathy: the patients’ perspectives.
J Pain. 2006;7(12):892-900.
cise protocol. An additional strength Acknowledgements 6. Tentolouris N, Al-Sabbagh S, Walker MG, Boulton
is the long duration of the study, Clinical support was provided by AJ, Jude EB. Mortality in diabetic and nondiabetic
patients after amputations performed from 1990
which included supervised and unsu- David Metzelfeld, DPT, and Cam Len- to 1995: a 5-year follow-up study. Diabetes Care.
pervised interventions that simulate drim, PTA of William Jennings Bryan 2004;27(7):1598-1604.
7. Boyko EJ, Ahroni JH, Stensel V, Forsberg
real-life scenarios. Dorn VA Medical Center. Paul Bartels, RC, Davignon DR, Smith DG. A prospective
Limitations of the study include PhD, of Warren Wilson College pro- study of risk factors for diabetic foot ulcer.
The Seattle Diabetic Foot Study. Diabetes Care.
a small sample size, case-controlled vided data analysis support. Anodyne 1999;22(7):1036-1042.
design rather than a randomized, Therapy, LLC, provided the MIRE unit 8. Centers for Disease Control and Prevention. Older
adults falls: get the facts. Centers for Disease Con-
double-blinded study, which can used in the clinic. trol and Prevention Website. http://www.cdc.gov
contribute to selection bias, inability /HomeandRecreationalSafety/Falls/adultfalls.html.
Updated July 1, 2015. Accessed August 8, 2015.
to differentiate between the benefits Author disclosures 9. Akbari M, Jafari H, Moshashaee A, Forugh B. Do
of physical therapy alone vs physical The authors report no actual or poten- diabetic neuropathy patients benefit from balance
training? J Rehabil Res Dev. 2012;49(2):333-338.
therapy and MIRE treatments, and tial conflicts of interest with regard to 10. Kruse RL, Lemaster JW, Madsen RW. Fall and bal-
retention of participants due to travel this article. ance outcomes after an intervention to promote leg
strength, balance, and walking in people with dia-
difficulties across a wide catchment betic peripheral neuropathy: “feet first” randomized
area. Disclaimer controlled trial. Phys Ther. 2010;90(11):1568-1579.
11. L emaster JW, Mueller MJ, Reiber GE, Mehr
This pilot study should be ex- The opinions expressed herein are those DR, Madsen RW, Conn VS. Effect of weight-
panded to a multicenter, randomized, of the authors and do not necessarily bearing activity on foot ulcer incidence in peo-
ple with diabetic peripheral neuropathy: feet
double-blinded study to clarify the reflect those of Federal Practitioner, first randomized controlled trial. Phys Ther.
most beneficial treatments for indi- Frontline Medical Communications 2008;88(11):1385-1398.
12. Tuttle LG, Hastings MK, and Mueller MJ. A mod-
viduals with diabetic neuropathy. Ex- Inc., the U.S. Government, or any of its erate-intensity weight-bearing exercise program for
amining the number of documented agencies. This article may discuss un- a person with type 2 diabetes and peripheral neu-
ropathy. Phys Ther. 2012;92(1):133-141.
falls pre- and postintervention may labeled or investigational use of certain 13. Gossrau G, Wähner M, Kuschke M, et al. Mi-
also be helpful to determine actual ef- drugs. Please review complete prescrib- crocurrent transcutaneous electric nerve
stimulation in painful diabetic neuropathy: a
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drug combinations—including indica- 2011;12(6):953-960.
CONCLUSION tions, contraindications, warnings, and
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