Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the eﬀect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy using Nerve conduction velocity examination.

Official Title
-----------------
Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy

Conditions
-----------------
Diabetic Peripheral Neuropathy

Intervention / Treatment
-----------------
* Device: Rotating Magnetic Therapy
* Drug: Mecobalamin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 1. Volunteer to participate and sign informed consent prior to the study 2. Patients with type 2 diabetes, who met WHO1999 diagnostic criteria, had diabetes distal symmetrical multiple neuropathy (1) clear history of diabetes; (2) neuropathy at or after diagnosis of diabetes;(3) clinical manifestations and signs are consistent with DPN;(4) have clinical symptoms (pain, numbness, paresthesia, etc.), 5 examination (ankle reflex, acupuncture pain sense, vibration sense, pressure sense, temperature sense) any 1 abnormal;If there were no clinical symptoms, 2 of the 5 examinations were abnormal.(5) exclude other causes of neuropathy). 3. HbA1c<7.5%, the hypoglycemic regimen was stable for 3 months 4. No acute complications, such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc. Exclusion Criteria: 1. Patients with foreign metal bodies or pacemakers 2. Patients with a history of surgery at magnetic therapy sites within one year 3. Patients with obvious discomfort to magnetic therapy 4. Patients with bleeding or bleeding tendency 5. Patients with acute complications such as diabetic ketoacidosis 6. Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal 7. History of drug abuse and alcohol dependence in the past 5 years 8. Systemic hormone therapy was used in the last three months 9. Patients with infection and stress within 4 weeks 10. Patients who are pregnant, breast-feeding, or intending to become pregnant. 11. Any other obvious conditions or co-existing diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors, other pancreatic diseases, patients with a history of mental illness, or severe wasting diseases
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control group<br>Mecobalamine 0.5mg, tid | Drug: Mecobalamin<br>* mecobalamine 0.5mg,tid<br>|
| Experimental: Rotating Magnetic Therapy<br>Rotating Magnetic Therapy 30min,bid + Mecobalamine 0.5mg, tid | Device: Rotating Magnetic Therapy<br>* Rotating Magnetic Therapy 30min, bid<br>Drug: Mecobalamin<br>* mecobalamine 0.5mg,tid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve conduction velocity examination | the change of Nerve conduction velocity examination | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MNSI | Michigan Neuropathy Screening Instrument | 1 month | 
| Glycosylated serum albumin | the change of Glycosylated serum albumin | 1 month |