After 30 min of supine rest, the Finapres and ECG signal were sampled at 100 Hz and stored on a personal computer during 15 min. Blood pressure was monitored by a Finapres 2300 (Ohmeda, Inglewood, CO) and heart rate by an ECG monitor (78351T Hewlett-Packard, Palo Alto, CA). All measurements took place in a quiet room with the temperature kept constant at 22☌. All participants were studied in the morning. In this study we used HRV as a tool reported to be sensitive and valid for diagnosis of diabetic autonomic neuropathy. Clinical standardsĬardiovascular autonomic function was assessed by analysis of continuous blood pressure and electrocardiogram (ECG) signals. The ability to sense the SW-MF correctly in six trials at both locations is defined as normal the inability to sense the SW-MF correctly in one of six trials is defined as mildly disturbed (score 1 point), and the inability to sense the SW-MF correctly more than one time is defined as disturbed and scores 2 points ( 11, 12). The 10-g SW-MF is tested on the plantar surface of the hallux and centrally at the heel. 3) NDF/CBO 3 is combined use of 128-Hz TF testing at the hallux and SW-MF testing (see NDF/CBO 4). When it is felt the same at that location the score is 0 points, when it felt stronger the score is 1 point. When something is felt, the still vibrating tuning fork is immediately placed at the dorsal wrist. The vibrating tuning fork is put on the interphalangeal joint, and when nothing is felt the score is 2 points. A 128-Hz tuning fork is used to examine vibration perception at the dorsum of the interphalangeal joint of the right hallux. (Normal score is 0 points, a mild/moderate deficit is 1 point, and severely disturbed/absent response is 2 points.) 2) NDF/CBO 2 is tuning fork testing. Items in these tests are scored from 0 to 2. 1) NDF/CBO 1 includes 128-Hz tuning fork and cotton wool testing at the hallux, SW-MF testing at the plantar surface of the foot (at the hallux and centrally at the heel), and ATR testing. Details of the clinical characteristics of each group are given in Table 1.Īlthough a combination of four tests is advised (NDF/CBO 1), for daily clinical practice the use of SW-MF testing and/or 128-Hz tuning fork testing at the hallux is suggested, which leads to three more possible combinations (NDF-CBO 2–4) ( 8). The third group consisted of 21 control subjects with normal glucose tolerance (control group). The normal ATR is considered for this purpose as an early and reliable sign of the absence of PNP ( 9, 10). A second group (diabetes control subjects group) of 24 diabetic patients had no (history of) foot ulcers or clinically overt signs of neuropathy (defined as a complete lack of complaints or symptoms suggestive for PNP and a normal Achilles tendon reflex as determined by the treating physician). These ulcers were purely neuropathic by origin, as was confirmed by their localization (plantar surface of the foot at high pressure points) and the absence of peripheral arterial disease as described below. The first group consisted of 24 diabetic patients with a history of neuropathic foot ulcers (diabetic ulcer group). For screening we therefore advise the use of the tuning fork alone.Īfter this screening and selection subjects received appointments in a randomized order. The single use of the 128-Hz tuning fork produces results similar to the extended scores of the ICDF and much better than those of monofilaments on validation and for predictive value. Reproducibility of the NDF/CBO scores (monofilaments and tuning fork) was high.ĬONCLUSIONS-The characteristics of the scores of tests recommended by ICDF and NDF/CBO are comparable. The predictive value was good for all scores, with the best results being obtained for the tuning fork (NDF/CBO). RESULTS-The construct validity and discriminative power of the ICDF and NDF/CBO scores were comparable, although monofilaments (NDF/CBO) scored lower. Reproducibility was tested in a separate study (13 patients). The Diabetic Neuropathy Symptom score, the Diabetic Neuropathy Examination score, Heart Rate Variability, the Nerve Conduction Sum score, and a San Antonio Consensus sum score were obtained as clinical standards. In all participants the scores from the International Consensus on the Diabetic Foot (ICDF) and the Dutch Nederlandse Diabetes Federatie-Centraal Beleids Orgaan (NDF/CBO) were tested. RESEARCH DESIGN AND METHODS-Three matched groups were selected: 24 diabetic patients with neuropathic foot ulcers, 24 diabetic patients without PNP or ulcers, and 21 control subjects without diabetes. The variety in these scores and the lack of data on validity and predictive value has led to a comparison and validation of the scores with clinical standards for PNP to determine the most powerful measurement for screening. OBJECTIVE-Several national and international scoring systems are used to diagnose diabetic polyneuropathy (PNP).
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