Diabetic Neuropathy.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Type 1 or 2 diabetes with stable metabolic status for =3 months Having symptoms of sensory neuropathy (numbness, burning, etc.) Age 40 to 75 years BMI 18.5–40 Willingness to participate in the study
Exclusion criteria
Exclusion criteria: Gestational diabetes or other specific types of diabetes Starting insulin therapy within the past month A history of hereditary neuropathy or other neuropathies Having other chronic diseases that cause neuropathy Unwillingness to participate in the study at any time or stage Neuropathy with severe lumbar canal stenosis requiring surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Michigan Neuropathy Screening Tool: The Michigan Neuropathy Screening Questionnaire is a two-part tool, with the first part consisting of 15 questions to be completed by the individual and the second part consisting of 4 questions to be completed after examination by a professional. In the first part, the answers are summed to obtain an overall score. A 'yes' answer to questions 1-3, 5-6, 8-9, 11-12, 14-15 and a 'no' answer to questions 7 and 13 each count as one point. A score greater than or equal to 7 is considered abnormal. All 15 questions are included in the new scoring algorithm. The second part includes a brief physical examination of the feet, a vibration perception test (both at the big toe and medial malleolus), Achilles tendon stretch reflex, and monofilament test. The vibration test will be performed with a tuning fork placed bilaterally at a frequency of 128 Hz on the posterior surface of the big toe over the bony prominence of the inferior malleolus and medial malleolus. With the patient's eyes closed, the patient is asked to inform the examiner when he or she can no longer feel the vibration applied by the tuning fork. Normally, the examiner is able to feel the vibration for 5 seconds longer than a normal person on the inferior malleolus of the thumb of the hand with which the tuning fork is held on the patient's big toe or medial malleolus.The scoring is as follows: if the difference between the time of cessation of the perception of vibration in the patient and the examiner is less than 10 seconds, this means that this sensation is present, but if this time reaches 10 seconds or more, it means that the perception of vibration has decreased, and if there was no perception of this sensation in the patient, it means that the perception of vibration has disappeared.The monofilament test will be assessed with a 10-gram Semmes-Weinstein monofilament. To perform the test, the patient is asked to lie on his back and close his eyes. The filament is applied | — |
Secondary
| Measure | Time frame |
|---|---|
| For electrodiagnostic examination of patients, a nerve conduction and electromyography (NCS/EMG) device will be used. The amplifier will be used to record the mentioned parameters with the specifications of the frequency band 10 Hz to 10 kHz, sweep speed 2-5 ms/div, sensitivity 1000-5000 µv/div, stimulation diurnition 100 microseconds, and current intensity starting from zero to maximum 50 mA with Notch Filter on and stimulation frequency set to 1 Hz, and speed values less than 40 m/s in the lower limb and less than 50 m/s in the upper limb will be considered as low speed and in the neuropathic range. For other parameters, please refer to the reference data.Regarding the stimulation points and recording of waves, to record the tibial motor nerve action potential response (Tibial CMAP), we place the stabilization electrode on the abductor hallucis muscle of the foot and place the stimulator behind the medial ankle and give the second part of the stimulation from the popliteal fossa. For the common peroneal nerve, recording is done from the extensor digitorum brevis muscle and stimulation is done on the ankle lateral to the T.A tendon and the second part of the stimulation is done from the fibular head. We measure the resulting waves in terms of amplitude, onset time and conduction velocity.To record the ulnar motor response (Ulnar CMAP), we place the stabilizing electrode on the abductor digiti minimi muscle of the hand and place the stimulator 8 cm higher on the ulnar side and give the second part of the stimulation from the medial epicondyle of the elbow. To record the median motor response (median CMAP), we place the stabilizing electrode on the abductor pollicis brevis muscle and give the stimulation 8 cm more proximally at the wrist and the second part of the stimulation is given at the antecubital part of the elbow. We measure the resulting waves in terms of amplitude, onset time and conduction velocity. (The average response of both sides will be recorded).SNA | — |
Countries
Iran (Islamic Republic of)
Contacts
Tabriz University of Medical Sciences