1. Utilization of ESWT to restore peripheral vibro-sensory perception in an insensate Type 1 diabetic foot:
An Original Exploratory Case Study.
Kenneth Craig,1Wayne Hing,2Gwyn Lewis,3Daniel Poratt,3Marjorie Walker4
1Director –KompassCentre for Shockwave Therapy and Research, Auckland. 2Professor –Research Dept. Bond University, Australia & Assoc. Prof. Health & Rehabilitation Institute, Auckland University of Technology, Auckland. 2Sr. Lecturer Health & Rehabilitation Institute, Auckland University of Technology, Auckland. 3Sr. Lecturer Podiatry Dept. Auckland University of Technology, Auckland. 4Physiotherapy Student Intern, Auckland University of Technology, Auckland.
Introduction
Peripheral insensitivity due to diabetes polyneuropathyis a common syndrome associated with both types of diabetes that places patients at a greater risk of developing ulcers and theassociated complications.
Aim
To introduce ESWT as a potential treatment option and undertake collaborative efforts to further investigate its efficacy in this area.
Table 1. Pre treatment case history, clinical presentation and basic instrumentation and quantitative test yields.
Materials and Method
Case-study involving a 59yr old male patient with a 50yr history of Type 1 diabetes with distal symmetrical sensorimotorpolyneuropathy(Table 1).
One limb selected as the treatment limb (Txl), and the other as control (Ctrl). 10g monofilament, 128Hz tuning fork, neurotips, biothesiometerand
electro-sensory stimulation (ESS) measured baseline and post-intervention outcomes. Six sessions of extracorporeal shockwave therapy (ESWT)
was administered over the 1stand 5thmetatarsals, lateral and medial malleolus, and the hallux. 500 impulses at 0.10mj/mm² were administered
over each region at 1 week intervals. Co-investigators were blinded to selection of the Txlvs. Ctrl throughout the treatment and follow-up period.
Result
At 8 weeks post-ESWT Txldemonstrated improvements of sensory perception to basic instrumentation such as monofilament (Table 2), neurotips(Table 3) and tuning fork (Table 4), while Ctrl remained unchanged. Txlrequired less stimulus utilizing biothesiometer(Baseline average 37.74volts; Post-ESWT avg. 28.04volts) (Table 5) (Figure 2). Similarly detection (DE), discomfort (DC) and pain (PN) thresholds of Txlutilizing ESS required less stimulus in each domain (Baseline DE: 25mA; 15mA post-ESWT); (Baseline DC: 45mA; 35mA post-ESWT), and (Baseline PN: 135mA; 105mA post-ESWT) (Table 6) (Figure 3). The Ctrl limb demonstrated further progressive detoriorationrequiring increased biothesiometerstimulus (Baseline 37.44volts; 40.07volts post trial) (Table 5) (Figure 2) and ESS respectively (Baseline DC: 35mA; 45mA posttrial) (Baseline PN: 65m; 75mA post trial) (Table 6) (Figure 3).
Discussion
Distal sensorimotorpolyneuropathy(DPN) is the most common form of neuropathic manifestation in both types of diabetes, and yet despite its prevalence there are currently no effective treatments available to arrest or modify disease progression other then optimal glyceamiccontrol and education, and these measures will not guarantee that patients will not develop DPN as factors other than hyperglycemia are involved with the development of this syndrome.1,3Although the exact mechanism of ESWT is yet to be fully elucidated, a dose dependant stimulus from shockwaves are seen to trigger a neuro-bio-chemical regulatory cascade that result in the resolution of various osseous, musculoskeletal, vascular and neurologiocalpathology.5,6,8,9,10Among the physiological impact of shockwaves on human tissue are: increased cell-membrane permeability, stimulus and regulation of both neural and endothelial nitric oxide synthase(nNOS& eNOS), collagen synthesis, progenitor cell nuclear antigen (PCNA), vascular endothelial growth factor (VEGF), and a host of inflammatory and pain modulating properties.5,6,8,9,10Although a variety of components may be responsible for the changes seen in this case-study, VEGF is a component that is of worthwhile mention in this instance as both dated and emerging evidence indicate that VEGF enhances and supports the growth and regeneration of nerve fibers possibly through a combination of angiogenic, neurotrophicand neuroprotectiveproperties.2,4,7
A pertinent observation noted in this case-study was that, the continued and insidious nature of the neuropathic disease progression was beyond the detection threshold capability of basicclinical instrumentation and was noted when using quantitative measurements such as biothesiometerand ESS.
Conclusion:
Although case studies are considered anecdotal evidence, the findings of this case-study suggests that ESWT may offer a non-invasive and systemically safe treatment option that induces and regulates the very physiological components necessary for the reversal of DPN. Further exploration is warranted to further explore the potential use of ESWT for the reversal of vibro-sensory deficits due to DPN in diabetics. This is the first instance where ESWT has been used in an attempt to restore vibro-sensory insensitivity due to DPN in a diabetic foot.
Reference
1.BoultonA. Medical Treatment of Symptomatic Diabetic Neuropathy. Immunology, Endocrinology & Metabolic Agents in Medicinal Chemistry.2007; 7, 79 –86.
2.CarmelietP & Tessier-LavigneM. Common mechanisms of nerve and blood vessel wiring. Nature. 2005; 436(7048): 193 –200.
3.Gale, E. A. M. Glucose control in the UKPDS: what did we learn? Diabetic Medicine. 2008; 25(S2) 9 -12.
4.Lopes PFR, LisboaBCG, FrattiniF, Almeida FM, et. al, Enhamcementof sciatic nerve regenarationafter vascular endothelial growth factor (VEGF) gene therapy. Neuropathology and ApplicedNeurobiology. 2011; 37: 600 –612.
5.MittermayrR, HartingerJ, AntonicV, et al. Extracorporeal Shock Wave Therapy (ESWT) Minimizes Ischemic Tissue Necrosis Irrespective of Application Time and Promotes Tissue Revascularization by Stimulating Angiogenesis. Ann Surg2011;253:1024–1032.
6.NortanicolaA, MorretiL, TafuriS el al. Shockwave therapy in the management of Complex Regional Pain Syndrome of the femoral condyleof the knee. Ultrasound Med Biol. 2010; 36(6):874-9.
7.Rosenstein JM & Krum JM. New roles for VEGF in nervous tissue –beyond blood vessels. 2004;187: 246 –253.
8.SaginniR, FigusA, TroccolaA et al. EXTRACORPOREAL SHOCK WAVE THERAPY FOR MANAGEMENT OF CHRONIC ULCERS IN THE LOWER EXTREMITIES. Ultrasound in Med. & Biol. 2008; 34( 8):1261–1271.
9.VasyukY, HadgegovaA, ShkolnikE, et al. Initial Clinical Experience With Extracorporeal Shock Wave Therapy in Treatment of Ischemic Heart Failure. CongestiveHeart Failure. 2010;16(5) 226 –230.
10.Wang C-J, KuoY-R, Wu R-W, et al. Extracorporeal Shockwave Treatment for Chronic Diabetic Foot Ulcers. Journal of Surgical Research. 2008 May;152 (1)
Case
Clinical Presentation
Left Limb –Baseline
Right Limb–Baseline
Male –59yrs.
HealthProfessional
•50yr HxT1DM
•Insulin glargine
26units
•Insulin lispro
4/10 units
•Symmetrical sensory deficits (seenext 2 columns)
•Pedal pulses –Presentbilaterally
•Deep tendon reflexes –Absent bilaterally
•Paresthesia(burning sensations) –bilaterally
•Dyesthesia–Left Hallux& 5thdigit
•Mild muscle weakness –bilateral leg compartments
•Gait and balance –Unremarkable
•Skin temperature to touch –Unremarkable
•Skin condition –Unremarkable
•Gait and balance -Unremarkable
•Neurotip–Not distinguished.
•10g monofilament -4/10 dermatomes
•128Hz tuning fork –Undetected
•Light touch –Undetected
•Hot / Cold –Detected
•Skin surface temperature –27.0˚C
•Biothesiometeraverage –37.74 volts
Electro-stimulation average:
•Detection (DE) –25mA
•Discomfort (DC) –45mA
•Pain (PN) –135mA
•Neurotip–Not distinguished.
•10g monofilament -4/10 dermatomes
•128Hz tuning fork –Undetected
•Light touch –Undetected
•Hot / Cold –Detected
•Skin surface temperature –27.5˚C
•Biothesiometeraverage –37.44 volts
Electro Sensory Stimulation (ESS) average:
•Detection (DE) –30mA
•Discomfort (DC) –35mA
•Pain (PN) –65mA
Figure 1. A shockwave (soundwave)
propagated by a controlled underwater explosion using an electro-hydraulic generator. The soundwaveis focused onto the region of interest using ultrasound gel as the transmission medium for the wave to penetrate tissue.
Device utilized in this study was an electro- hydraulic OrthoSpecOR2 operated by KC in the presence of an intern observer (MW) to ensure treatments were carried out devoid of patient coaching.
Region
Baseline
Txl.
Post ESWT
Txl.
Baseline
Ctrl.
Post Study
Ctrl,
Hallux
XX
++
XX
XX
1stMTPJ
XX
++
XX
XX
3thMTPJ
XX
++
XX
XX
5thMTPJ
XX
++
XX
XX
Calcaneus
XX
XX
XX
XX
Region
Baseline
Txl.
Post ESWT
Txl.
Baseline
Ctrl.
Post Study
Ctrl.
Hallux
XX
++
XX
XX
3rdPhalangealpulp
XX
++
XX
XX
5thPhalangealpulp
++
++
++
++
1stMTPJ
XX
++
XX
XX
3rdMTPJ
XX
++
XX
XX
5thMTPJ
XX
++
XX
XX
Medial mid-arch
++
++
++
++
Lateral mid-arch
++
++
++
++
Doral footregion
++
++
++
++
Region
Baseline Average Txl.
Post-ESWT
Average Txl.
Change Value Txl.
Baseline Average Ctrl.
Post-study
Average Ctrl.
Changevalue Ctrl.
Hallux
44.6
27.3
-17.3
44.6
45.0
+0.4
1stMTPJ
39.6
26.0
-13.6
32.0
38.6
+12.6
5thMTPJ
32.6
25.0
-7.6
28.0
31.6
+3.6
Lateral Malleolus
36.6
28.3
-8.3
42.0
43.3
+1.3
Medial Malleolus
35.3
33.6
-1.7
40.6
41.6
+1.0
Table 4. Sensitivity to 128Hz tuning fork at 8 weeks. XX (Not Detected), ++ (Detected)
Table 5. Comparison of the average biothesiometerstimulus detection between TxlvsCtrl at 8 weeks. Three (3) readings were taken over each region with a 5 minute interval in between. Baseline, Post-ESWT & Post study figures are the average of the 3 readings. Biothesiometerassessment was conducted by a blinded investigator (DP) with KC & MW as observers.
Table 2. Sensitivity to 10g monofilament at 8 weeks post-intervention. XX (Not detected), ++ (Detected).
Table 3. Sensitivity to Neurotips(sharp vsblunt) stimulus at 8weeks. XX (Not detected), ++ (Detected).
Region
Baseline
Txl.
Post ESWTTxl
Baseline
Ctrl.
Post Study
Ctrl.
Hallux
XX
++
XX
XX
1stMTPJ
XX
++
XX
XX
5thMTPJ
XX
++
XX
XX
Lateral Malleolus
XX
++
XX
XX
Medial Malleolus
XX
++
XX
XX
Domain
Baseline
Txl
Post ESWT
Txl
Baseline
Ctrl.
Post Study
Ctrl.
Detection (DE)
25
15 (-10)
30
20 (-10)
Disconfort(DC)
45
35 (-10)
35
45 (+10)
Pain (PN)
135
105 (-30)
65
75 (+10)
Table 6. Comparison of the average electro sensory stimulation (ESS) testing the domain of: stimulus detection, stimulus induced discomfort and stimulus induced pain. Material used was a Digimeter(model DS7A), used to send an electrical impulses graduated at 5miliamperes (mA‘s) to determine sensory nerve conduction. The nerve being tested in this instance was the tibialnerve, as it innervates the regions being treated (with the exception of the lateral malleolus). Location of electrodes were attached just inferior to the medial malleolusof each foot. Three (3) readings were taken from each foot at 15 minute intervals. Confounding observation was that Ctrl required less stimulus in the domainofdetection, while all other tests on Ctrl demonstrated continued deterioration. ESS was conducted by a blinded investigator (GL) with KC & MW as observers.
Figure 2. Graphical depiction of sensory changes at 8 weeks to stimulus to a biothesiometer.
Green bars (Txl).
Red bars (Ctrl).
Figure 3. Graphical description of sensory changes at 8 weeks to ESS.
Green bars (Txl)
Red (Ctrl)