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临床试验/IRCT20210315050706N1
IRCT20210315050706N1已完成未知

The effect of local magnetic therapy on clinical symptoms of peripheral neuropathy in patients with diabetes type 2

Gonabad University of Medical Sciences0 个研究点目标入组 64 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
64

研究概览

简要总结

Background: Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM) that can cause annoying symptoms. To address this condition, several treatment approaches have been proposed, including static magnetic field (SMF) therapy, which has shown promise in treating neurological conditions. Therefore, this study aimed to investigate the effects of SMF therapy on symptomatic DPN and the quality of life (QoL) in patients with type 2 diabetes. Methods: A double-blind, randomized, placebo-controlled trial was conducted from April to October 2021. Sixty-four DPN patients (20 males, 44 females) were recruited for the study via invitation. The participants were divided into two groups: the magnet group, which used magnetic ankle bracelets (155mT) for 12 weeks, and the sham group, which used non-magnetic ankle bracelets for the same duration. Neuropathy Symptom Score (NSS), Neuropathic Disability Score (NDS), and Visual Analogue Scale (VAS) were used to assess neuropathy symptoms and pain. In addition, the Neuropathy Specific Quality of Life Questionnaire (Neuro-QoL) tool was used to measure the patients' quality of life. Results: Before treatment, there were no significant differences between the magnet and sham groups in terms of the NSS scores (P=0.50), NDS scores (P=0.74), VAS scores (P=0.17), and Neuro-QoL scores (P=0.82). However, after 12 weeks of treatment, the SMF exposure group showed a significant reduction in NSS scores (P<0.001), NDS scores (P<0.001), VAS scores (P<0.001), and Neuro-QoL scores (P<0.001) compared to the baseline. The changes in the sham group, on the other hand, were not significant. Conclusion: According to obtained data, SMF therapy is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL in diabetic type-2 patients.

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 70 years(—)
性别
All

入选标准

  • Diabetes type 2; diagnosed by a diabetologist according to American Diabetes Association (ADA) standards
  • Diabetic peripheral neuropathy at least 6 scores on the Neuropathy disability score (NDS) without Neuropathy Symptoms score (NNS) or 3-5 scores on NDS with at least 5 scores on NSS
  • Drug-refractory neuropathic pain intensity at least 1 score on Visual analogue scale
  • Able to complete questionnaires and willing to sign written informed consent
  • Aged 18–70 years (either sex)

排除标准

  • Pregnancy, planning a pregnancy, lactation
  • Had any of the following: Vascular insufficiency, Renal failure, Metallic implantation, Skin diseases, Foot ulcers, Prosthesis, Prior magnetic therapy, Cardiac pacemaker, Mechanical insulin pump or any electronic device
  • Had diabetic peripheral neuropathy from other causes than diabetes (according to the medical history and diagnosis of specialist doctors)
  • Opiate or drug abuse

研究者

发起方
Gonabad University of Medical Sciences

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