Electroacupuncture for Treating Painful Diabetic Neuropathy: A multi-center, randomized, assessor-blinded, controlled trial

Korea Institute of Oriental Medicine0 个研究点目标入组 126 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

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•1. Males and females aged 19 years
•2. Diagnosed as Type II diabetes mellitus
•3. Distal symmetric lower limb pain had been present for at least 6 months
•4. At least during four days before randomization, having a score of = 4 on the 11-point pain intensity numerical rating scale (PI-NRS) for pain of diabetic peripheral neuropathy
•5. At least 2 on the history and physical exam portion of the Michigan Neuropathy Screening Instrument (MNSI)
•6. At least two abnormaility of the following measures
•- vibration perception by 128Hz tuning fork
•- 10g monofialment test
•- Ankle reflexes
•7. Agreed with written informed consent

•1. HbA1c > 10%
•2. Diagnosed as Diabetic Foot Ulcer
•3. Different cause of neuropathic pain other than diabetes (malignant disease, tarsal tunnel syndrome, neurothlipsis, deficiency of Vit B12, hypothyroidism, neurotoxicity (e.g. lead, alcohol, smoking), medication (chemotherapy, isoniazid), transient ischemic attack, stroke, multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, Uremic Neuropathy, subacute combined degeneration of spinal cord, phantom limb pain, artherosclerosis obliterans)
•4. Other severe pain than painful diabetic neuropathy (e.g. arthritis, back pain, stenosis, Herniated intervertebral disc(HIVD))
•5. Received medication, electrical therapy, patch treatment (lidocaine or capsaicin), acupuncture, moxibustion, cupping or herbal medicine for painful diabetic neuropathy last 2 weeks
•6. Psychoneurotic causes: epilepsy, depression, panic disorder
•7. Cardiovascular disorder (e.g. arrhythmia) or using pascemaker
•8. Known hypersensitivity reaction after acupuncture treatment or inability to cooperate with acupuncture procedure
•9. Pregnant, expecting pregnant or breast-feeding women
•10. Those who are not willing to comply with this study protocol

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