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SORRI ® MONOFILAMENT AESTHESIOMETER

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1. Av Na es Unidas 53 40 Bauru SP 17033 260 BRAZIL Pat Pending TOUCH SENSITIVITY TESTING KIT c User s Manual PRECAUTIONS e Read this Manual carefully and study the instructions before you use the instrument e f any doubt should arise as to the correct procedure in any specific situation please consult the qualified personnel at SORRI BAURU INDEX PRECAUTIONS INTRODUCTION INTENDED USE PLES OF OPERATION ND BACKGROL CHARACTERISTICS AND USE OF THE INSTRUMENT EXAMINA PROTOCOL MOUNTING and USING the MONOFILAMENTS THRES Pd z MAPPING tl EQUI E WITH OTHER TESTS CLEA FILAMENTS LOOKING AFTER YOUR FILAMENTS FAQS REFERENCES INTRODUCTION The SORRI BAURU Touch Sensitivity Testing Kit is a Synthetic monofilament aesthesiometer INTENDED USE The sense of touch afforded by our nervous system is an important point of contact with the world around us It permits the perception of objects helps to protect the skin and underlying tissues against damage providing the rapid perception of light touch or deep pressure and discriminating between rough and smooth movement or vibration a gentle contact or a sharp point Changes in the tactile perception threshold of the skin can impair this ability we have to protect us from dangerous objects or eventualities around us The SORRI aesthesiometer kit serves to evaluate and monitor the degree of skin sensi
2. Nominal 0 05 gf Shape stereognosis and temperature discrimination retained Deep pressure and pain sensation retained Awareness of position and movement proprioception retained Normal sensation Threshold lt 0 05gf Touch discrimination of symbols traced on the skin graphaesthesia retained Light touch and texture discrimination retained Blue Nominal 0 2 gf Shape and temperature discrimination retained Deep pressure and pain sensation retained Proprioception retained Diminished light touch sensation 0 05 gf threshold 0 2 gf Loss of graphaesthesia Difficulty with fine texture discrimination Purple Nominal 2 0 gf Difficulty or loss of stereognosis and thermal discrimination Deep pressure and pain sensation retained Proprioception retained Diminished protective sensation 0 2 gf lt threshold lt 2 0 gf Loss of graphaesthesia Loss of fine texture discrimination Red Nominal 4 0 gf Loss of protective sensation threshold 4 0 gf for hand threshold 10 0 gf for foot Loss of stereognosis and usually thermal discrimination Loss of graphaesthesia Deep pressure and pain sensation retained Orange Loss of fine texture discrimination Proprioception retained Nominal 10 0 gf Light Red Deep pressure sensation 10 0 gf threshold 300 gf Loss of stereognosis and thermal discrimination Nominal 300 gf Lo
3. BIRKE J A and SIMS D S Plantar sensory threshold in the ulcerative foot In Lepr Rev 57 261 267 1986 BOOTH J and YOUNG M J Differences in the Performance of Commercially Available 10g Monofilaments Diabetes Care vol 23 N 7 984 988 2000 BRASIL Minist rio da Sa de Funda o Nacional de Sa de Centro Nacional de Epidemiologia Coordena o Nacional de Dermatologia Sanit ria Guia de controle da hansen ase Segunda edi o Bras lia 1994 BRASIL Minist rio da Sa de Secretaria de Vigil ncia em Sa de Departamento de Vigil ncia Epidemiol gica Manual de preven o de incapacidades 3 ed rev e ampl Bras lia Minist rio da Sa de 2008 FRYKBERG R G J Foot Ankle Surg 37 5 440 446 1998 in De Luccia Nelson Altera es Neurovasculares nos P s de Pacientes Diab ticos apostila USP KUMAR S FERNANDO D J S VEVES A KNOWLES M J and BOULTON A J M Semmes Weinstein monofilaments a simple effective and inexpensive screening device for identifying diabetic patients at risk of foot ulceration Diabetes Research and Clinical Practice 13 1 2 63 68 1991 rd LEHMAN L F ORSINI M P B NICHOLL A R J The development and adaptation of Semmes Weinstein monofilaments in Brazil Hand Therapy Philadelphia 1993 LEVIN S PEARSALL G and RUDERMAN R J Von Frey s method of measuring pressure sensibility in the hand An engineering analysis of the Weinstein Semmes
4. 1989 BACKGROUND e After several attempts to introduce and spread through Brazil a practical method for the evaluation of functional changes in the cutaneous touch sensitivity of people with leprosy professionals from American Leprosy Missions ALM brought the problem to SORRI Bauru an innovative Brazilian non profit involved in the rehabilitation process with a focus on the stigma and social rejection problems associated with leprosy Through its vocational training activities SORRI had an already prominent programme for development of assistive technology and special products e In collaboration with ALM and the Lauro de Souza Lima Hospital now a Research Institute SORRI Bauru s product designer developed a portable instrument robust reliable and easy to use in the clinic or in the field even in adverse conditions LEHMAN et al 1993 The Kit developed by SORRI Bauru follows Sidney Weinstein s proposal to use mounted nylon filaments of equal lengths varying only their diameter WEINSTEIN 1962 Weinstein as is known based his ideas on the experimental work of the European physiologist Maximilian Von Frey who used animal hairs calibrated to provide precise stimulus values Von FREY 1922 CHARACTERISTICS AND USE OF THE INSTRUMENT The SORRI touch sensitivity testin
5. fibre sizes which were by diameter in thousandths of an inch whole numbers only A selection was made of twenty suitable diameters from the range between 2 and 45 Once cut to length these could be identified by diameter or more usefully by the critical axial force necessary to initiate buckling This value was obtained directly by measurement in the laboratory Despite the use of the word pressure in the literature the actual pressure transmitted may only be obtained by calculation because it depends on this force and also on the contact area which may vary during the application of the filament Further the same pressure value might be applied by a heavy force distributed over a large area as by a light force over a relatively small area and this would have very different effects on the nerves Thus in general manufacturers tend to use the established units of force instead of some estimate of pressure or stress to identify each monofilament In the past to facilitate graphic demonstrations since a logarithmic scale of applied forces approximates a linear scale of the perceived strength this was done by using the variable M which is calculated as the logarithm of ten times the force in milligrams required to bow the filament M log 10 Fmg Thus the filaments were marked with a number such as 2 83 or 3 61 etc Some manufacturers still use this system despite the problems of interpretation that it g
6. gradually opened the scope of its mission which through a wide range of services and activities now aims toward the long term empowerment of disabled people and their families and the construction of an inclusive society The manufacture and distribution of the monofilament skin sensitivity testing kit is one of the ways that SORRI participates in the prevention of disabilities while revenue from the sales helps to maintain the quality of services provided without cost to disabled members of the community SORRI BAURU Av Na es Unidas 53 40 Bauru SP CEP 17033 260 Telephone 55 014 4009 1000 Fax 55 014 4009 1041 Home page www sorribauru com br e mail estesiometro sorri com br Social http www facebook com SORRIBAURU photo courtesy of Leandro Barros
7. reserve filaments 7 Before starting the test always bend each filament twice as a warm up Bell Krotoski 1989 BOOTH amp YOUNG 2000 FAQs Frequently Asked Questions SETS OF SIX OR SETS OF TWENTY MONOFILAMENTS The SORRI kit composed of 6 selected diameters of Nylon 612 monofilament was designed for convenience and efficiency in evaluating functional sensitivity thresholds of the peripheral nerves of the hands and feet The use of a reduced number of filaments to identify important functional thresholds was established by Werner and Omer 1970 validated by Bell Krotoski 1990 A sixth filament was added following widespread acceptance of the proposals of Birke and Sims 1986 In some research projects that aim to investigate subtle changes of sensitivity in other parts of the body a denser grid may be justifiable with smaller increments of discrimination such as is offered by the set of 20 monofilaments These sets are not available from SORRI The Standard Kit contains six different filament diameters each with a second filament in reserve except for the most delicate green filament which comes with three reserves constituting a total of 14 filaments in seven protective tubes SENSATION of 10 g FILAMENT DEMONSTRATES a HEALTHY FOOT Q According to the instructions accompanying the Kit if a patient cannot feel the lighter filaments at a given site but responds affirmatively to the touch of the
8. 10 g Orange filament the interpretation suggested would be Definite loss of protective sensation for the foot Pressure and pain may still be felt in hands and feet and the location should be mapped with a red X Why then when screening with a single 10 g filament would the patient be classified as not at high risk A The apparent conflict that arises when comparing this protocol with the use of a single filament of 10 grams for rapid screening to identify patients at high risk for foot ulcers especially diabetic foot is a question of degree of risk The importance of being able to feel pain already appears in the teaching of Paul Brand in the 50s but the term Protective Sensation only seems to date back to the work of Kilulu von Prince and Bruce Butler 1967 who demonstrated that the ability to feel the 4 grams force filament as the lightest filament noticeable at a given site is evidence for the absence of protective sensation in the case of the hands and sometimes of the foot When the patient is unable to feel that filament on the foot but only feels the 10 grams force filament protective sensation is already also lost in the foot Despite the ready availability at the time of the 20 filament sets used by Weinstein and Semmes the observations of Birke and Sims 1986 were based on tests using only the filaments of 1 10 and 75 grams force Kumar and colleagues 1991 testing close to existing ulcers also found that no patient a
9. HOLD MAPPING PROTOCOL Perform the evaluation in the sequence listed below and for each site tested document the first nylon that has a positive response Lightest filament whose touch can be felt INTERPRETATION Suggested mapping code Sensation within normal limits for the hand and foot Green filled circle Diminished light touch sensation in the hand with difficulty in fine tactile discrimination Within normal limits for the foot Blue filled circle Diminished protective sensation in the hand but sufficient to prevent injury Gross tactile discrimination shape and temperature discrimination are difficult Purple filled circle Loss of protective sensation for the hand in some cases for the foot Hands particularly vulnerable to injuries Usually loss of temperature discrimination Definite loss of protective sensation for the foot Pressure and pain may still be felt in hands and feet Still able to feel deep pressure and pain Red filled circle Red cross Red circle No response Loss of deep pressure sensation Usually does not feel pain Proprioceptive function may persist 00x00 Black filled circle EQUIVALENCE WITH OTHER TESTS AND ASSOCIATED FUNCTIONAL LEVELS Correlation between functional skin sensitivity thresholds and traditional tests was first observed by Von Prince amp Butler 1967 Threshold Equivalence Green
10. ale No plantar ulcer was observed situated at the level of sensitivity of the 4g monofilament The monofilament 5 07 10g seems to be a warning sign for diabetes patients because complications become more frequent at this level which shows loss of mechanism for protection and defense of the feet That should put both patient and physician on the alert to effectively initiate preventive measures through a consistent program aimed at maintaining the integrity of the feet Emphasis added Others Von Prince K Butler B Jr Measuring sensory function of the hand in peripheral nerve injuries Am J Occup Ther 1967 21 6 385 95 Kamei N Yamane K Nakanishi S Yamashita Y Tamura T Ohshita K et al Effectiveness of Semmes Weinstein monofilament examination for diabetic peripheral neuropathy screening J Diabetes Complications 2005 19 1 47 53 Birke JA Sims DS Plantar sensory threshold in the ulcerative foot Lepr Rev 1986 57 3 261 7 Boyko EJ Smith DG Ahroni JH A propective study of risk factors for diabetic foot ulcer Rehabil RD Progress Reports 1994 32 318 9 Rith Najarian SJ Stolusky T Gohdes DM Identifying diabetic patients at high risk for lower extremity amputation in a primary health care setting A prospective evaluation of simple screening criteria Diabetes Care 1992 15 10 1386 9 TERMINOLOGICAL CONFUSION FORCE PRESSURE M Semmes Weinstein monofilaments were originally chosen from the commercially available nylon
11. alm environment without noise or distractions e Tactile sensation may alter with temperature Allow the patient who has just come in out of strong sunshine or from the cold enough time to adjust to normal temperature e Prepare mapping evaluation sheets and colour pens prior to testing Careful documentation facilitates case analysis and the use of colour coding helps to quickly interpret observations e The following procedure should first be demonstrated on an area of skin where there is good sensitivity and the subject can observe the process e When the patient understands the testing procedure his vision is excluded and the tester begins the sensory test documenting as threshold the first affirmative response in each site tested In Hansen s disease the WHO Disability Grading of Grade 1 is documented when any palmar or plantar area has a LOSS of PROTECTIVE SENSATION Therefore any area where the first positive test response is to a 4 0 gf or heavier filament red or black area should be documented as a GRADE 1 DISABILITY MOUNTING and USING the MONOFILAMENTS Withdraw from the tube the filament nearest to the mounting holes and introduce it carefully through the Ju P transversal mounting holes until the support is firm Prepare one filament of each colour _ oa 9 The other filament remains in the protective tube as a reserve ii Damaged kinked or bent filaments should be discarded and replaced with a new filament
12. enerates In fact this practice was already identified as a source of potential confusion in the article by Scott Levin back in 1978 The problem is further complicated in some studies where the logarithmic value is associated with the acronym MN Marking Number easily confused with mN or milinewtons unit of force accepted in the International System of Units SI At the suggestion of specialists from the Research Department of the Leprosy Center in Carville Louisiana when developing the Sensitivity Testing Kit SORRI eliminated this complication in the identification of their filaments by using the simple force value The value is marked in grams force or simply g and represents the rounded value of the force necessary to initiate a bend in the filament during correct application of the test Today many other models of monofilament aesthesiometer also adopt this more rational system REFERENCES n Qv Un dm ota BACARIN TA AKASHI PMH SACCO ICN Duration of disease neuropathy symptoms and plantar sensitivity in diabetic patients with and without previous plantar ulceration Wounds v 20 p 37 45 2008 BELL KROTOSKI J A Light touch deep pressure testing using the Semmes Weinstein monofilaments In Hunter JM et al Eds Rehabilitation of the Hand 3 ed St Louis CV Mosby Co Ch 42 1989 BELL KROTOSKI J A Pocket Filaments and specifications for the Semmes Weinstein monofilaments J Hand Surg 3 26 31 1990
13. g kit is designed as a simple and convenient means of detecting and monitoring functional alterations in the peripheral nerves It consists of a flexible plastic wallet containing a set of seven tubes each containing a pair of special nylon filaments Six of the tubes are drilled transversally to provide mounting holes to maintain the filament in the correct position for use Each tube has two nylons one of which is a reserve To facilitate interpretation a colour code is used to indicate the approximate axial force necessary to bend each filament The Kit also contains a tube with a spare set of the most delicate filaments 0 05 g green and the set of holes in this tube allow it to be used as a convenient support for the other tubes when they are mounted for use Other combinations of filaments may sometimes be available for example single tube packs with a particular filament and its reserve for use in specific screening tests Each wallet contains an explanatory leaflet with instructions for care of the instrument and information about its use It also provides suggestions to facilitate mapping of the results and a grid to assist with interpretation of the results EXAMINATION PROTOCOL To ensure reliability of the test it is fundamental to carefully follow a standard procedure e The validity of a sensory test is dependent on rigorous adherence to a standard procedure e Thetesting should take place in a c
14. lready with foot ulcer could feel the touch of a filament of 10 grams or less at these sites But the risk precedes the ulcer Worth looking carefully at the work mentioned below Souza A Nery CA S Marciano LH S C Garbino J A Avalia o da neuropatia perif rica correla o entre a sensibilidade cut nea dos p s achados cl nicos e eletroneuromiogr ficos ACTA FISIATR 2005 12 3 87 93 In the discussion appears Several studies have been conducted to investigate the reliability of the use of monofilament in peripheral neuropathies and at the same time to determine the limits of perception that may cause harm to patients with sensory loss Thus Birke and Sims were the first to set the level of protective sensation for assessment of leprosy and diabetic patients with plantar ulcer using monofilaments 4 17 5 07 and 6 10 that correspond to the force of 1g 10g and 75g respectively The cited authors found that no patient with a foot ulcer could feel the 5 07 10g monofilament and concluded as other subsequent studies that this filament is the best indicator of protective sensation and a valid tool in predicting patients at risk of plantar lesions In the present study although it is considered as a loss of protective sensation to feel the touch of the 4g monofilament it was observed that patients who showed a more severe clinical picture exceeded this limit going on to feel only the monofilament immediately higher in the sc
15. of the same specifications e Hold the tube so that the nylon filament is perpendicular to the subject s skin but not touching The test begins with the lightest filament green and continues through progressively heavier filaments until a positive response is obtained Without letting the patient see touch the nylon to the skin with a smooth gentle pressure which just causes the nylon to bend The pressure is maintained for about 2 seconds and then the filament is lifted smoothly away ifthe nylon slides over the skin the test at this site should be repeated 9 Askthe patient to say yes when he feels the filament Apply the green and blue filaments up to three times at each test site before confirming absence of sensitivity at this level Never use the same filament on more than 10 patients a day utilise the reserve filament Filaments should be cleaned by washing the nylon very carefully with 7096 alcohol and or warm soapy water after which the nylon is rinsed with water but not left to soak These filaments should not be used on the eyes or mucous tissue or open wounds In the case of ulcers scars or callus tissue perform the test on a nearby site within the same peripheral nerve territory To avoid damaging the filaments while replacing them carefully in their protective tubes after use it is helpful to block the mounting holes by holding the tube between finger and thumb TRADITIONAL THRES
16. pressure aesthesiometer The Journal of Hand Surgery 3 3 211 216 1978 SEMMES J WEINSTEIN S GHENT L e TEUBER HL Somatosensory Changes after Penetrating Wounds in Man Harvard University Press for the Commonwealth Fund Cambridge 60 61 1960 SOUZA A NERY CA MARCIANO LH GARBINO JA Avalia o da neuropatia perif rica correla o entre a sensibilidade cut nea dos p s achados cl nicos e eletroneuromiogr ficos ACTA FISIATR 2005 12 3 87 93 Von FREY MRF Versp tete Schmerzempfindungen Z Gesamte Neurol Psychiat 79 324 33 1922 Von PRINCE K and BUTLER B Jr Measuring sensory function of the hand in peripheral nerve injuries Am J OccupTher v 21 n 6 p 385 395 1967 WEDDELL G JAMISON D AND PALMER E Recent investigations into sensory and neurohistological changes in leprosy In Leprosy in Theory and Practice R G Cochrane ed Bristol John Wright amp Sons Ltd 1959 pp 96 113 WERNER JL OMER GE Evaluating cutaneous pressure sensitivity of the hand Am Journal of Occupational Therapy 24 347 356 1970 ABOUT SORRI SORRI which means SMILE in Portuguese is a Brazilian non governmental organisation NGO founded in 1976 in the town of Bauru Its purpose was to remedy the local lack of services for disabled people and at the same time to help break down the stigma associated with the disease of Leprosy Hansen s disease It is a non profit rehabilitation centre and has
17. ss of graphaesthesia Deep pressure and pain sensation retained Loss of fine texture discrimination Proprioception retained No response at the site tested Deep pressure sensation loss threshold gt 300 gf no response to Loss of stereognosis and thermal discrimination 300 gf nylon Loss of deep pressure sensation Loss of graphaesthesia Pain sensation may persist Loss of fine texture discrimination Proprioception may still be present CLEANING THE FILAMENTS The aesthesiometer monofilaments can be used for testing many patients provided that the necessary care is taken for hygienic purposes The object of cleaning is to reduce the risk of infection and the spread of pathogens Brief instructions for use and cleaning of the instrument accompany the SORRI kit e t is recommended to carefully wash the filaments immediately after use avoiding stretching or crushing the filament in the process A liquid soap solution in warm water can be used optionally with 496 chlorhexidine but avoiding other additives especially iodine and its compounds PVP iodophor etc e Then wipe with 7096 ethyl alcohol and allow the filament to dry e t is not recommended to use isopropyl alcohol as nylon is reported to have a relatively low resistance to this liquid e The filaments should not be left to soak because the absorption of water or alcohol may cause temporary changes in the elasticity of the nylon e The se
18. t is not designed to withstand the high temperature sterilization processes e Under ideal conditions the esthesiometer can maintain its accuracy for many years but after a period of 18 months of use it is recommended to replace the instrument to avoid changes in the calibration which may occur with time as a result of the accumulation of small chemical and physical effects e Any filament presenting sign of damage wrinkled bent cracked etc must be replaced The kit already includes reserve filaments of each size and replacement units can also be purchased at SORRI TAKING CARE OF YOUR FILAMENTS 1 Keep the filaments out of the sun and protected from UV light sources 2 Prevent the filaments from coming into contact with chemical reagents acids alkalis oxidizing agents among others 3 Keep in a dark dry and well ventilated place 4 As you store each filament carefully after use it is a good idea to cover the transversal mounting holes with finger and thumb to prevent the end of the filament from escaping and being damaged 5 If a filament shows signs of damage e g sharp bend break hardening undulations it should be discarded Replacement filaments can be obtained at SORRI 6 It is important to allow the filaments to rest for 24 hours after repeated use BOOTH amp Young 2000 Switch to reserve filaments after every 100 touches or after testing with 10 patients on the same day remember that the SORRI set provides
19. tivity to forces applied as stimuli to the nerves which should be sensitive to light touch and pressure The forces are graded in steps reflecting the functional thresholds considered most critical for the hands and feet Bell Krotoski 1989 composed of six force levels between 0 05 gf 0 49 mN and 300 gf 2 94 N Thus the instrument allows detection and monitoring of functional alterations of the patient s peripheral nerves In diabetes and leprosy as well as other diseases that cause debilitating neuropathies early detection of such changes is fundamental in order to prevent disability prevent injuries and reduce risk of amputations PRINCIPLES OF OPERATION e Anylon filament tends to bend elastically when a compression force applied axially reaches a critical value LEVIN et al 1978 e Under typical laboratory or clinic conditions this critical force depends on the elastic modulus of the nylon the monofilament length and its diameter e n these conditions the elastic modulus is constant while the diameter and length are carefully controlled in the manufacturing process of the instrument e Thus when properly applied a clear sign curve of the filament appears when the critical force known for each filament is applied via the filament e Evenifthe filament suffers slightly more compression or a slight vibration the elastic curvature of the filament effectively helps maintain a constant applied force BELL KROTOKI

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