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IRCT20210315050706N1 IRCT 2021-03-16 Gonabad University of Medical Sciences The effect of local magnetic therapy on the clinical symptoms of peripheral neuropathy The effect of local magnetic therapy on clinical symptoms of peripheral neuropathy in patients with diabetes type 2 2021-03-27 anticipated 64 Complete https://irct.ir/trial/55022 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The research units will be selected from the people referring to the hospital clinic in a purposive sampling method by considering the inclusion criteria. Then they will be assigned to the two intervention and control groups using the four-shift block method. In this way, the letter "A" will be considered for the intervention group, and the letter "B" will be considered for the control group. The possible states in the quadruple block are six states, each state will be written on a card and the cards will be assigned the numbers one to six. Then, using the dice, one of the six possible states will be selected and the selected patients will be divided into two groups. This process will continue until the sample size is completed, Blinding description: Participants, as well as the corresponding author, the outcome evaluator, the data analyst, and the physician in charge of patient care, became unaware of the group position of patients, as well as the nature of the wristband containing the real or neutral magnet. N/A Diabetic neuropathy. Intervention 1: Intervention group: For patients in this group for local magnetic therapy, a leather wristband with a neodymium bipolar magnet with an average magnetic intensity of 155 mTesla in the size of 15 x 3 mm will be used. The wristband at the end of the tibial nerve pathway in the lower of the leg, around the ankle, will be used continuously 24 hours a day for 12 weeks. Intervention 2: Control group: In this group, the same wristband and magnet with the same size and shape will be used at the same time, with the difference that the magnet used in this group is neutral and does not have magnetic properties. The wristband at the end of the tibial nerve pathway in the lower of the leg, around the ankle, will be used continuously 24 hours a day for 12 weeks. https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-023-01123-9 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Armin Nazeri
Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Khorasan Razavi, Gonabad, Asia Road
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 5027 Nazeri.a.stu@gmu.ac.ir Gonabad University of Medical Sciences scientific Armin Nazeri
Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Khorasan Razavi, Gonabad, Asia Road
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 5027 Nazeri.a.stu@gmu.ac.ir Gonabad University of Medical Sciences Iran (Islamic Republic of) 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) 18 years 70 years Both 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 G99.0 Autonomic neuropathy in diseases classified elsewhere Treatment - Devices Placebo Intervention group: For patients in this group for local magnetic therapy, a leather wristband with a neodymium bipolar magnet with an average magnetic intensity of 155 mTesla in the size of 15 x 3 mm will be used. The wristband at the end of the tibial nerve pathway in the lower of the leg, around the ankle, will be used continuously 24 hours a day for 12 weeks. Control group: In this group, the same wristband and magnet with the same size and shape will be used at the same time, with the difference that the magnet used in this group is neutral and does not have magnetic properties. The wristband at the end of the tibial nerve pathway in the lower of the leg, around the ankle, will be used continuously 24 hours a day for 12 weeks. Severity of clinical symptoms of diabetic neuropathy. Timepoint: At the beginning of the study and 4, 8 and 12 weeks after the start of the intervention. Method of measurement: Neuropathy symptom score questionnaire. Severity of neuropathic pain. Timepoint: The beginning of the study and weeks 4, 8 and 12. Method of measurement: Visual analogue scale questionnaire. Severity of neuropathy disability. Timepoint: The beginning of the study and the 12th week after the start of the intervention. Method of measurement: neuropathy disability score questionnaire. Quality of life. Timepoint: The beginning of the study and the 12th week after the start of the intervention. Method of measurement: NeuroQol questionnaire. Gonabad University of Medical Sciences Approved 2021-03-15 Ethics committee of Gonabad University of Medical Sciences Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Khorasan Razavi, Gonabad, Asia Road Gonabad Razavi Khorasan Iran (Islamic Republic of)