KCT0000466招募中未知
Electroacupuncture for Treating Painful Diabetic Neuropathy: A Randomized, Controlled Pilot Clinical Trial
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1. Males and females aged 18 to 75 years
- •2. Diagnosed as Type I or 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 3 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. Stable use (variation of major drug = 25%) had been made in their anti-painful diabetic neuropathic medications within 3 months before screening or no use of anti-painful diabetic neuropathic medications within 1 month. Patients are allowed to take a maximum of 3g of rescue medication (acetaminophen) per day.
- •8. Agreed with written informed consent
排除标准
- •1. Substance abuse or dependence
- •2. Cardiovascular disorder (e.g. arrhythmia) or using pascemaker
- •3. Psychoneurotic scauses : epilepsy, depression, panic disorder
- •4. At least other symtoms related with diabetes within 3 months
- •5. HbA1c > 11%
- •6. Diagnosed as Diabetic Foot Ulcer
- •7. Other severe pain than painful diabetic neuropathy (e.g. arthritis, back pain)
- •8. Abnormal level of blood test (HbA1c, Glucose, BUN, Creatinine, TSH, T3, free T4, Vit B12) or urine test (urine protein)
- •9. 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)
- •10. Known hypersensitivity reaction after acupuncture treatment or inability to cooperate with acupuncture procedure
- •11. Used electrical therapy of patch treatment (lidocaine or capsaicin) for painful diabetic neuropathy last 2 weeks
- •12. Received acupuncture, moxibustion, cupping or herbal medicine for painful diabetic neuropathy last 2 weeks
- •13. Those who have participated in other clinical trials during the past 3 months
- •14. Pregnant, expecting pregnant or breast-feeding women
- •15. Those who are not willing to comply with this study protocol
研究者
相似试验
招募中
不适用
Electroacupuncture for Treating Painful Diabetic Neuropathy: A multi-center, randomized, assessor-blinded, controlled trialEndocrine, nutritional and metabolic diseaseKCT0001135Korea Institute of Oriental Medicine126
招募中
不适用
Acupuncture for Symptomatic care of Type 2 Diabetic MellitusKCT0000940Korea Institute of Oriental Medicine15
尚未招募
不适用
Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral NeuropathyDiabetic Peripheral Neuropathic PainNCT06054087Zhejiang Chinese Medical University104
尚未招募
不适用
Cupping for Treating Painful Diabetic Neuropathy: A single group before-and-after, preliminary studyEndocrine, nutritional and metabolic diseaseKCT0001316Korea Institute of Oriental Medicine15
Unknown
3 期
Effect of Electroacupuncture in Diabetic Patients With GastroparesisDiabetes MellitusGastroparesisNCT00227383China Medical University Hospital30