ISRCTN11665378进行中（未招募）未知
The utility of frequency-modulated electromagnetic neural stimulation as a third-line treatment in patients with painful diabetes-related peripheral neuropathy: a randomised controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 356
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =18 years
- •2. Neuropathic pain affecting both feet for =3 months or taking pain medication for neuropathic pain for =3 months
- •3. Mean pain score =4 on the daily NRS for 1 week prior to randomisation
- •4. Douleur Neuropathique 4 (DN-4) questionnaire score =4/10 at screening to confirm the diagnosis of bilateral distal symmetrical neuropathic pain
- •5. Diabetes-related neuropathy based on the Michigan Neuropathy Screening Instrument (MNSI) (MNSI questionnaire scored =7 or examination scored >2)
- •6. HbA1c <108 mmol/mol or 12% (within the last 2 months)
- •7. Have tried at least two drugs from two different classes for PDPN
- •8. Willing and able to comply with the study schedule and be available for the treatment duration
- •9. Able to give written informed consent
排除标准
- •1. Non-diabetic neuropathies
- •2. Currently using TENS for PDPN
- •3. History of epilepsy
- •4. Other painful medical conditions where the pain is significantly more severe than their PDPN pain (patients will not be excluded if the pain is transient in nature)
- •5. Major amputations of the lower limbs
- •6. Active diabetic foot ulcers
- •7. Diagnosed malignancy
- •8. Pacemakers, defibrillator or neurostimulator
- •9. Pregnancy
研究者
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