Reliability and Responsiveness of an 18 Site, 10-g Monofilament Examination for Assessment of Protective Foot Sensation

Young, Daniel PT, DPT; Schuerman, Sue PT, GCS, PhD; Flynn, Kimberly PT, DPT; Hartig, Krista PT, DPT; Moss, Danielle PT, DPT; Altenburger, Beth PT, MS

Journal of Geriatric Physical Therapy:
doi: 10.1519/JPT.0b013e31820aabe5
Research Reports

Purpose: Older persons including those with diabetes are at increased risk for loss of protective sensation in the feet. The 5.07 (10-g) monofilament is recognized as a valid instrument to test for the presence or absence of protective sensation in the foot. Few studies report reliability and no studies report responsiveness for a multisite examination using the 10-g monofilament. The purpose of this study was to determine the responsiveness and reliability for the 10-g monofilament in evaluating protective sensation in the feet.

Materials/Methods: A convenience sample of 28 (20 women and 8 men) participants between the ages 50 and 78 years were recruited for the study. Sensory testing was performed on 18 different sites (9 per foot) by 3 testers for each participant using the 10-g monofilament. Participants were tested on 2 occasions with approximately 1 week between tests. Participants' eyes were closed for the duration of the examination to blind them to the tester. Testers were blinded to each other and previous test results.

Results: Intratester and intertester reliability were calculated using intraclass correlation coefficients (ICC). Intratester ICC (3, 1) and minimal detectable change at the 95% confidence level (MDC95) were calculated for each tester and then averaged yielding the following: ICC = 0.76 (95% CI: 0.68–0.84), MDC95 = 2.83. Intertester ICC (2, 1) was 0.78 (95% CI: 0.64–0.88). MDC95 was 2.81. This gives an MDC95 for this test of 3 sites.

Conclusions: The results of this study support the use of the 10-g monofilament as a reliable clinical tool to assess changes in protective sensation of the feet for our participant pool. An 18-site sensory examination using the 10-g monofilament must result in sensory change at 3 or more sites to indicate actual change in protective sensation.

Author Information

1Department of Physical Therapy, School of Allied Health Sciences, University of Nevada, Las Vegas.

2Tru Physical Therapy, Henderson, Nevada.

3Clarian Health Partners, Physical Therapy Wound Management, Indianapolis, Indiana.

Address correspondence to: Daniel Young, PT, DPT, Department of Physical Therapy, School of Allied Health Sciences, University of Nevada, Las Vegas, 4505 S Maryland Parkway, Box 453029, Las Vegas, NV 89154 (

Article Outline
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There are many diseases and health conditions that lead to or increase risk of loss of protective sensation (LOPS) of the foot. Some of the most common are diabetes, spina bifida, Hansen's Disease, systemic lupus erythematosus, human immunodeficiency virus infection, AIDS, AIDS-related complexity, cancer, vitamin B deficiency, multiple sclerosis, uremia, vascular disease, and Charcot-Marie-Tooth disease.15 Loss of protective sensation will raise the risk for undetected injury that can ultimately result in ulceration, infection, and amputation.1–4,6–8 Impaired sensation can also compromise gait and balance, increasing the risk for falls.7,8 Advanced age and altered foot biomechanics increase this risk when combined with pathologies that can precipitate LOPS.710

Prevention of the morbidity caused by LOPS can be facilitated by effective screening and clinical examination sensitive enough to detect changes in a persons' protective sensation. The 5.07, 10-g monofilament is used as a screening tool to determine whether further evaluation of protective sensation in the feet is warranted.13,1113 This screening strategy is time-efficient, easy-to-use, low-cost, and it has demonstrated predictive ability and reliability.13,1416 To screen for the presence or absence of protective sensation in the diabetic foot, the American Diabetes Association has recommended performing a 10-g monofilament test at the plantar hallux and metatarsal heads, and 1 additional clinical test (eg, vibration testing using a 128-Hz tuning fork, tests of pinprick sensation, ankle reflex assessment, and testing vibration perception threshold with a biothesiometer).1,2 However, even this recommendation is not without dispute in the literature; “The combination of two simple tests (eg, the 10-g SWME and vibration testing by the on-off method) does not add value to each individual screening test.”15

The literature is not specific on how many test sites on the foot are necessary when using the 10-g monofilament to establish LOPS.4,710,1324 Loss of protective foot sensation in persons with different pathologies may not be uniform, requiring monofilament testing of multiple sites to assess specific dermatomes and peripheral nerve distributions.

While the current literature reports good reliability of the monofilament to detect neuropathy when compared to other tests of foot sensation,911,13,14,16,2328 we found only 1 report that reported the intraclass correlation coefficient (ICC) statistic.25 No other reports offer any information regarding the responsiveness of a multisite examination.21,25,26 Also, reports often do not individually consider protective sensation and frequently group all monofilament forces together when reporting reliability.7,8,25,28

The suggestion has been made that inability to sense the 10-g monofilament at even 1 site would direct the clinician to consider that the person has impairment of protective sensation.7,14,22 However, the increased health care cost of inappropriate diagnosis of LOPS, as well as the imperfect reliability associated with monofilament testing, suggest that more information is needed to guide the clinician.12 The authors sought to establish the reliability and responsiveness, via minimal detectable change (MDC), for an 18-site (9 per foot) examination of protective sensation in the feet using a 10-g monofilament.

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After obtaining approval from the institutional review board, a convenience sample of 28 participants (mean age = 61.12 years, SD = 9.05; 20 women and 8 men) was recruited from a diabetes fair and via flyer to participate. Among the participants, 6 had a diagnosis of diabetes and 3 had a diagnosis of peripheral neuropathy. To be included in the study, participants had to be 50 years or older, have no cognitive impairment, be English speaking, and be able to lie supine for up to 15 minutes. Potential participants were excluded from the study if they had any skin ulceration of the lower extremity, any active malignancy, and any prior joint replacement in the lower extremity.

Three testers reviewed the testing protocol that came from the manufacturer of the monofilament (North Coast Medical, Inc, 18305 Sutter Boulevard Morgan Hill, California) and practiced briefly on each other until they felt prepared to begin testing participants (5–10 practice trials). Testing procedures followed those outlined in the manufacturers' instructions and are similar to other procedures described in previous studies: the participant was positioned in supine, the testing procedure was demonstrated on the participants' hand or forearm along with a brief description of the test.11,19,22,25 Participants were instructed to alert the tester whenever they felt the monofilament on any of the test sites by saying “yes” and to remain silent if no sensation was experienced. If participants said, “yes” when the monofilament was not in contact with the skin, nothing was recorded. However, the sites tested just before and after this verbalization were repeated. Participants kept their eyes closed throughout the testing. A single individual provided instruction to the participant for all 3 testers, who did not verbally interact with the participant. Each tester applied the filament to the target sites on the plantar surface in random order. Order of testers for each participant was also random. Because their eyes were closed, participants were blinded to each tester. Testers were blinded from the results of their fellow testers, as well as their previous results. Participants were tested twice, in sessions no more than 1 week apart. In each session, the filament was applied to 18 sites (9 on each foot) representing dermatomes and peripheral nerve distributions (Figures 1 and 2).

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Data Analysis

To determine the intratester reliability of the 18-site 10-g monofilament test, the average intratester reliability value from model 3 of the ICC was computed using SPSS, version 17.0 (SPSS Inc, Chicago, Illinois).29 To determine intertester reliability for the 3 testers, model 2 of the ICC was used.29 Interpretation of the ICC values for this study follows commonly used grouping, where an ICC value of less than 0.40 indicates poor reproducibility, ICC values in the range 0.40 to 0.75 indicate fair to good reproducibility, and an ICC value of greater than 0.75 shows excellent reproducibility.30 Using the reliability value from the intertester ICC, the Standard Error of Measurement (SEM) was calculated with the following formula:29

where rxx = test-retest reliability.

For an individual, MDC at a 95% confidence level (MDC95) can be calculated by multiplying the SEM by 1.96 (representing 95% of the area under a normal distribution curve) and 1.41 (the square root of 2) to control for possible error when calculating the coefficient from 2 data sets (test and retest in this example):31

Individual MDC95 is typically used as a benchmark for change in individual clients or participants. Group MDC95 is frequently used by researchers or clinicians to detect a statistically significant change in the mean score of a group. To calculate the MDC95 for a group, MDC95 for the individual is divided by the square root of the number (n) of people in the group:31

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The intratester ICC (3, 1) and MDC95 were calculated for each tester and then averaged yielding the following: ICC = 0.76 (95% CI: 0.68–0.84), Individual MDC95 = 2.83, Group MDC95 = 0.53. The ICC (2,1) for intertester data was calculated and yielded the following: ICC = 0.78 (95% CI: 0.64–0.88), Individual MDC95 = 2.81, Group MDC95 = 0.53.

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Results from the present study support other studies indicating that the 10-g monofilament is a reliable tool. Also, responsiveness of the tool using MDC95 in an 18-site examination was assessed. A 3-site change in protective sensation was determined to be the MDC at a 95% confidence interval on an individual level. Therefore, when performing an 18-site examination of protective sensation using the 10-g monofilament, a change in 3 or more sites would allow the clinician to be 95% confident an actual change in protective sensation had occurred. This allows for more accurate and confident referral, client education, and disease progression or regression measurement.

A change of at least 0.53 sites was determined to be the group MDC95. Therefore, if a group of patients has realized a mean change of 0.53 sites on the 18-site monofilament examination, then researchers or health care providers could confidently conclude that group of patients had a statistically significant change in their protective sensation. While the group MDC is not typically used by health care providers, it can be used to determine whether the mean score of a group of participants with similar characteristics has changed significantly from a previous measurement. In the case of an 18-site examination for LOPS, it could be used to determine whether a group of similar patients (eg, (50 years old with diagnosed DM) in an outpatient clinic were experiencing a significant change in their protective sensation from 1 year to the next by taking the difference in the means between the 2 years.

A limitation of this study may be that only 1 touch of the monofilament per test site was performed during testing. While this was according to the manufacturers' instructions, other researchers have used up to 10 touches per test site before a determination was made on the sensation of that site.9,1316,19,25,32,33 The authors recommend that each site be tested 3 times and the best 2 of the 3 responses be used to score the site as described by other researchers.19 The participants in this study demonstrated experimenter expectancy33 by occasionally saying “yes,” when the monofilament was not in contact with the skin. In future studies, the authors recommend that participants be asked to point to the foot location on a diagram where they felt the monofilament.

Also, it may have been difficult for multiple testers to consistently place the monofilament in exactly the same test location. In future studies, drawing circles or dots around or on site locations on the participants' feet before testing may help to reduce or eliminate intertester inaccuracy when placing the monofilament.

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An 18-site 10-g monofilament examination demonstrated good reliability and had an individual MDC95 of 3 sites for the participant pool in this study. By repeating the examination over time and comparing the results, clinicians can be confident that a change in protective sensation at 3 or more sites on the 18-site examination represents actual improvement or decline in the protective sensation of their individual clients.

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The authors thank Merrill Landers, PT, DPT, for his assistance with the statistical analysis of this manuscript.

Funding: None.

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1. Boulton AJM, Vinik AI, Arezzo JC, et al. Diabetic neuropathies: a statement by the American Diabetes Association. Diabet Care. 2005;28:956–962.
2. Boulton AJM, Armstrong DG, Albert SF, et al. Comprehensive foot examination and risk assessment. Diabet Care. 2008;31:1679–1685.
3. Boyko EJ, Ahroni JH, Stensel V, Forsberg RC, Davignon DR, Smith DG A prospective study of risk factors for diabetic foot ulcer: the Seattle Diabetic Foot Study. Diabet Care. 1999;22:1036–1042.
4. Duffy JC, Patout CA Jr Management of the insensitive foot in diabetics: lessons learned from Hansen's disease. Mil Med. 1990;155:525–529.
5. Sussman C, Bates-Jensen BM Wound Care: A Collaborative Practice Manual for Health Professionals. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2007:720.
6. McNeely MJ, Boyko EJ, Ahroni JH, et al. The independent contributions of diabetic neuropathy and vasculopathy in foot ulceration: how great are the risks? Diabet Care. 1995;18:216–219.
7. Mueller MJ Identifying patients with diabetes mellitus who are at risk for lower-extremity complications: use of Semmes-Weinstein monofilaments. Phys Ther. 1996;76:68–71.
8. Perry SD Evaluation of age-related plantar-surface insensitivity and onset age of advanced insensitivity in older adults using vibratory and touch sensation tests. Neurosci Lett. 2006;392:62–67.
9. Diamond JE, Mueller MJ, Delitto A, Sinacore DR Reliability of a diabetic foot evaluation. Phys Ther. 1989;69:797–802.
10. Thompson R, John P St., Montgomery P, Van Ineveld C The Semmes Weinstein Monofilament test in the elderly. J Can Geriatr Soc. 2005;8:55–59.
11. Birke JA, Sims DS Plantar sensory threshold in the ulcerative foot. Lepr Rev. 1986;57:261–267.
12. McGill M, Molyneaux L, Spencer R, Heng LF, Yue DK 4-g monofilament is clinically useful for detecting diabetic peripheral neuropathy. Diabet Care. 2001;24:183–184.
13. Smieja M, Hunt DL, Edelman D, Etchells E, Cornuz J, Simel DL Clinical examination for the detection of protective sensation in the feet of diabetic patients. International Cooperative Group for Clinical Examination Research. J Gen Intern Med. 1999;14:418–424.
14. Olaleye D, Perkins BA, Bril V Evaluation of three screening tests and a risk assessment model for diagnosing peripheral neuropathy in the diabetes clinic. Diabet Res Clin Pract. 2001;54:115–128.
15. Perkins BA, Olaleye D, Zinman B, Bril V Simple screening test for peripheral neuropathy in the diabetes clinic. Diabet Care. 2001;24:250–256.
16. Rahman M, Griffin SJ, Rathmann W, Wareham NJ How should peripheral neuropathy be assessed in people with diabetes in primary care? A population-based comparison of four measures. Diabet Med. 2003;20:368–374.
17. Forouzandeh F, Ahari AA, Abolhasani F, Larijani B Comparison of different screening tests for detecting diabetic foot neuropathy. Acta Neurol Scand. 2005;112:409–413.
18. Jeng C, Michelson J, Mizel M Sensory thresholds of normal human feet. Foot Ankle Int. 2000;21:501–504.
19. Kamei N, Yamane K, Nakanishi S, et al. Effectiveness of Semmes-Weinstein monofilament examination for diabetic peripheral neuropathy screening. J Diabet Complications. 2005;19:47–53.
20. Klenerman L, McCabe C, Cogley D, Crerand S, Laing P, White M Screening for patients at risk of diabetic foot ulceration in a general diabetic outpatient clinic. Diabet Med. 1995;13:561–563.
21. Nather A, Neo SH, Chionh SB, Liew SCF, Sim EY, Chew JLL Assessment of sensory neuropathy in diabetic patients without diabetic foot problems. J Diabetes Complications. 2008;22:126–131.
22. Sloan HL, Abel RJ Getting in touch with impaired foot sensitivity. Nursing. 1998;28:50–51.
23. Valk GD, De Sonnaville JJJ, Van Houtum WH, et al. The assessment of diabetic polyneuropathy in daily clinical practice: reproducibility and validity of Semmes Weinstein monofilaments examination and clinical neurological examination. Muscle Nerve. 1997;20:116–118.
24. Lee S, Kim H, Choi S, Park Y, Kim Y, Cho B Clinical usefulness of the two-site Semmes-Weinstein Monofilament Test for detecting diabetic peripheral neuropathy. J Korean Med Sci. 2003;18:103–107.
25. Birke JA, Brandsma JW, Schreuders TAR, Piefer A Sensory testing with monofilaments in Hansen's disease and normal control subjects. Int J Lepr Other Mycobact Dis. 2000;68:291–298.
26. Anderson AM, Croft RP Reliability of Semmes Weinstein monofilament and ballpoint sensory testing, and voluntary muscle testing in Bangladesh. Lepr Rev. 1999;70:305–313.
27. Holewski JJ, Stess RM, Graf PM, Grunfeld C Aesthesiometry: quantification of cutaneous pressure sensation in diabetic peripheral neuropathy. J Rehabil Res Dev. 1988;25:1–10.
28. Van Brakel WH, Khawas IB, Gurung KS, Kets CM, Van Leerdam ME, Drever W Intra- and inter-tester reliability of sensibility testing in leprosy. Int J Lepr Other Mycobact Dis. 1996;64:287–298.
29. Portney LG, Watkins MP Foundations of Clinical Research: Applications to Practice. 2nd ed. Upper Saddle River, NJ: Prentice Hall; 2000:768.
30. Rosner B, et al.. Fundamentals of Biostatistics. Belmont, CA. Duxbury Press; 2005.
31. Beaton DE, Bombardier C, Katz JN, Wright JG A taxonomy for responsiveness. J Clin Epidemiol. 2001;54:1204–1217.
32. Meijer J-G, Van Sonderen E, Blaauwwiekel EE, et al. Diabetic neuropathy examination: a hierarchical scoring system to diagnose distal polyneuropathy in diabetes. Diabet Care. 2000;23:750–753.
33. Meijer JWG, Smit AJ, Sonderen EV, Groothoff JW, Eisma WH, Links TP Symptom scoring systems to diagnose distal polyneuropathy in diabetes: the diabetic neuropathy symptom score. Diabet Med. 2002;19:962–965.

monofilament; reliability; reproducibility; responsiveness; sensory

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