The effect of local magnetic therapy on the clinical symptoms of peripheral neuropathy

Not Applicable

Conditions: Diabetic neuropathy.
Autonomic neuropathy in diseases classified elsewhere
G99.0

Registration Number: IRCT20210315050706N1

Lead Sponsor: Gonabad University of Medical Sciences

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 64

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.