Protocol summary
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Study aim
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Determining the effect of local magnetic therapy on clinical symptoms of peripheral neuropathy in patients with type 2 diabetes
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Design
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A randomised, double-blind, sham controlled clinical trial with a parallel group design of 64 patients
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Settings and conduct
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This study is a randomized clinical trial and patients are divided into intervention and control groups based on permutation blocks. The sample size in each group is 32 and the research site will be the diabetes clinic of Alavi hospital in Mashhad. For the intervention group, magnetic therapy will be used 24 hours a day for 12 weeks. In the control group, the magnet which is completely similar to the intervention group without magnetic properties, will be used at the same time. Patients, the main researcher and the physician in charge of patient care and the person analyzing the data will not to know the nature of the real or neutral magnet, as well as the group position of the patients.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Diabetic peripheral neuropathy at least 6 scores on score Neuropathy disability score (NDS) without Neuropathy symptoms score (NSS) 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
Aged 18–70 years (either sex)
Exclusion criteria:
Pregnancy, planning a pregnancy, lactation
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Intervention groups
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Patients in the intervention group will use a magnet with an intensity of 155 mT for local magnetic therapy. The magnet at the end of the tibial nerve pathway in the lower leg, around the ankle, will be used 24 hours a day for 12 weeks.
In the control group, a magnet of the same size and shape but neutralized and without magnetic properties will be used at the same place and time
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Main outcome variables
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Clinical symptoms of neuropathy
General information
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Reason for update
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To add study results and final changes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210315050706N1
Registration date:
2021-03-16, 1399/12/26
Registration timing:
prospective
Last update:
2024-01-04, 1402/10/14
Update count:
1
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Registration date
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2021-03-16, 1399/12/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-03-27, 1400/01/07
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Expected recruitment end date
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2021-04-27, 1400/02/07
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Actual recruitment start date
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2021-04-20, 1400/01/31
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Actual recruitment end date
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2021-08-06, 1400/05/15
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Trial completion date
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2021-11-06, 1400/08/15
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Scientific title
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The effect of local magnetic therapy on clinical symptoms of peripheral neuropathy in patients with diabetes type 2
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Public title
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The effect of local magnetic therapy on the clinical symptoms of peripheral neuropathy
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
64
Actual sample size reached:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-03-15, 1399/12/25
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Ethics committee reference number
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IR.GMU.REC.1399.132
Health conditions studied
1
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Description of health condition studied
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Diabetic neuropathy
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ICD-10 code
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G99.0
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ICD-10 code description
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Autonomic neuropathy in diseases classified elsewhere
Primary outcomes
1
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Description
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Severity of clinical symptoms of diabetic neuropathy
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Timepoint
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At the beginning of the study and 4, 8 and 12 weeks after the start of the intervention
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Method of measurement
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Neuropathy symptom score questionnaire
Secondary outcomes
1
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Description
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Severity of neuropathic pain
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Timepoint
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The beginning of the study and weeks 4, 8 and 12
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Method of measurement
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Visual analogue scale questionnaire
2
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Description
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Severity of neuropathy disability
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Timepoint
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The beginning of the study and the 12th week after the start of the intervention
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Method of measurement
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neuropathy disability score questionnaire
3
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Description
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Quality of life
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Timepoint
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The beginning of the study and the 12th week after the start of the intervention
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Method of measurement
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NeuroQol questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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This research was supported by a grant from Gonabad University of Medical Sciences.
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Grant code / Reference number
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630
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Gonabad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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There is no more information
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When the data will become available and for how long
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There is no more information
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To whom data/document is available
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There is no more information
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Under which criteria data/document could be used
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There is no more information
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From where data/document is obtainable
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There is no more information
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What processes are involved for a request to access data/document
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There is no more information
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Comments
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Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2024-01-04, 1402/10/14
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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2023-07-04, 1402/04/13
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Abstract of published paper
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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.