Determining the effect of local magnetic therapy on clinical symptoms of peripheral neuropathy in patients with type 2 diabetes
Design
A randomised, double-blind, sham controlled clinical trial with a parallel group design of 64 patients
Settings and conduct
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, 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.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patient with type 2 diabetes with neuropathy
Having informed consent to participate in the study
Having neuropathic pain and sensory disturbance according to the NSS
Age under 65 years
non Inclusion criteria:
Disease or condition affecting neuropathy (multiple sclerosis, gout, Parkinson, spinal cord injury, Guillain-Barre, rheumatic disease) with the approval of a neurologist
Proven or suspected deep vein thrombosis
Intervention groups
Patients in the intervention group will use a magnet with intensity of 170-200 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
Main outcome variables
Clinical symptoms of neuropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210315050706N1
Registration date:2021-03-16, 1399/12/26
Registration timing:prospective
Last update:2021-03-16, 1399/12/26
Update count:1
Registration date
2021-03-16, 1399/12/26
Registrant information
Name
Armin Nazeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5027
Email address
nazeri.a.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-27, 1400/01/07
Expected recruitment end date
2021-04-27, 1400/02/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local magnetic therapy on clinical symptoms of peripheral neuropathy in patients with diabetes type 2
Public title
The effect of local magnetic therapy on the clinical symptoms of peripheral neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with type 2 diabetes with peripheral neuropathy
The patient's willingness and conscious consent to participate in the study
Having neuropathic pain and symptoms such as paresthesia and burning and numbness according to the NSS scale
Consciousness and ability to speak and communicate to report the severity of clinical symptoms during the examination
Age under 60 years
Exclusion criteria:
Disease or condition affecting neuropathy (stroke, multiple sclerosis, gout, Parkinson, spinal cord injury, Guillain-Barre, rheumatic disease) with the approval of a neurologist
Proven deep vein thrombosis or suspected deep vein thrombosis
Existence of cardiac arrhythmias
Age
To 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
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 and then 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 number 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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Khorasan Razavi, Gonabad, Asia Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2021-03-15, 1399/12/25
Ethics committee reference number
IR.GMU.REC.1399.132
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
G99.0
ICD-10 code description
Autonomic neuropathy in diseases classified elsewhere
Primary outcomes
1
Description
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 outcomes
empty
Intervention groups
1
Description
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 170 to 200 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.
Category
Other
2
Description
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.