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10.6-µm Infrared Laser as Adjuvant Therapy for Diabetic Peripheral Neuropathy: a Double-Blind, Randomized Controlled Trial

Phase 1
Conditions
Diabetic peripheral Neuropathy
Registration Number
ITMCTR2000002935
Lead Sponsor
Shanghai Municipal Hospital of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) diagnosed with DPN in both lower extremities;
(2) aged 18–75 years old, no limit on gender;
(3) delayed nerve conduction velocity in lower extremities;
(4) stable levels of blood glucose level (FPG <= 7.0 mmol/L2hPBG <= 8 mmol/LHbA1c <= 7%);
(5) understanding and signing the informed consent.

Exclusion Criteria

(1) neuropathy or chronic pain caused by conditions other than diabetes;
(2) DPN most prevalent in the upper limbs;
(3) Presence of serious medical conditions, including kidney diseases, heart diseases, pulmonary diseases, liver diseases or contagious diseases, or malignant tumors and serious psychopathy;
(4) Previous history of knee/hip replacement surgery or bone fracture of the lower extremities during the last 3 months and other conditions that would confound assessment of neuropathy;
(5) Ulceration and other diseases at the lower extremities;
(6) Acupuncture or moxibustion treatment received in the previous 3 months;
(7) LLLT received in the previous 3 months;
(8) Using other external therapy simultaneously;
(9) Opiate, analgesic, illicit drug or alcohol abuse;
(10) Unwillingness to be randomly assigned into either a treatment or a placebo group;
(11) Unable to fill measurement questionnaires;
(12) Recruited in other clinical trial simultaneously;
(13) Pregnant or breast-feeding women.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
erve Conduction Velocity;
Secondary Outcome Measures
NameTimeMethod
Michigan Neuropathy Screening Instrument;
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