Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy

Not Applicable

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Device: Rotating Magnetic Therapy; Drug: Mecobalamin

• Registration Number: NCT03983200
• Lead Sponsor: Majianhua

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-12
• Last Update Submitted: 2019-06-13
• Study Start: 2019-06-15
• Last Update Posted: 2019-06-17
• Primary Completion: 2019-11-15
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotating Magnetic Therapy	Rotating Magnetic Therapy	Rotating Magnetic Therapy 30min,bid + Mecobalamine 0.5mg, tid
Control group	Mecobalamin	Mecobalamine 0.5mg, tid
Rotating Magnetic Therapy	Mecobalamin	Rotating Magnetic Therapy 30min,bid + Mecobalamine 0.5mg, tid

Primary Outcome Measures

Name	Time	Method
Nerve conduction velocity examination	1 month	the change of Nerve conduction velocity examination

Secondary Outcome Measures

Name	Time	Method
MNSI	1 month	Michigan Neuropathy Screening Instrument
Glycosylated serum albumin	1 month	the change of Glycosylated serum albumin