Status:
UNKNOWN
Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy
Lead Sponsor:
Zhejiang Chinese Medical University
Collaborating Sponsors:
The First Affiliated Hospital of Zhejiang Chinese Medical University
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Conditions:
Diabetic Peripheral Neuropathic Pain
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Diabetic Peripheral Neuropathy (DPN) is one of the most common chronic complications of diabetes mellitus, which mainly manifests symmetric pain, numbness, ankylosis, or with abdominal distension, abn...
Detailed Description
A total of 104 subjects with DPN who meet the inclusion criteria will be included in the study. Subjects will be classified as mild, moderate and severe in terms of severity by using the toronto clini...
Eligibility Criteria
Inclusion
- 18 years ≤ age ≤ 85 years, disease duration is not limited, gender is not limited;
- Lower limb neuromuscular electromyography showing reduced conduction velocity, and/or persistent pain and/or sensory abnormalities in the extremities (at least in both lower limbs), bilateral or unilateral weakened ankle reflexes, reduced vibration sensation, and a TCSS score ≥ 6;
- Have normal communication skills;
- No serious heart, brain, liver, kidney and other internal diseases, no serious mental illness and cognitive impairment;
- those who voluntarily obeyed the study protocol and signed the informed consent form.
Exclusion
- Persons with peripheral neuropathy, ulcers and gangrene of the limbs caused by a variety of other reasons (e.g. hypothyroidism, alcohol, drugs, heredity, etc.), or persons with a history of skin ulcers or lesions that do not heal easily;
- Presence of serious diseases, including renal disease, cardiovascular disease, pulmonary disease, liver disease or infectious disease, or malignant tumour and serious mental illness, etc;
- Prior history of knee/hip replacement surgery or lower limb fracture within the past 3 months, and other conditions that may affect the assessment of neuropathy
- Patients who have received acupuncture or moxibustion treatment for DPN within the past 3 months;
- Volunteers who are participating in other interventional clinical trials;
- Women who are preparing for pregnancy, pregnant or breastfeeding;
- Those who have scars or hyperpigmentation of the skin at the testing site, which affects the accuracy of the test;
- Unwilling to be randomly assigned to the waiting treatment group or electroacupuncture treatment group;
- Chronic abuse of opioids, analgesics, illicit drugs or alcohol.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06054087
Start Date
October 1 2023
End Date
December 31 2025
Last Update
September 26 2023
Active Locations (1)
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1
the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang, China