Status:
COMPLETED
ACUpuncture in Diabetic Peripheral Neuropathy
Lead Sponsor:
Benno Brinkhaus
Collaborating Sponsors:
Karl and Veronica Carstens Foundation
Conditions:
Diabetic Neuropathy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care.
Detailed Description
The study will investigate the effect of a series of acupuncture treatments on subdimensions of neuropathic symptoms, such as pain, tingling and numbness. Neurophysiological testing of the affected ne...
Eligibility Criteria
Inclusion
- Inclusion Criteria, among others:
- Diagnosis of diabetic peripheral neuropathy in diabetes mellitus Type 2
- Males and females aged \>18yrs \< 70yrs
- Minimum overall complaints of minimum 40mm on a visual analogue scale (VAS)
- Completed titration of pain medication against diabetic peripheral neuropathy
- Pathological nerve conduction velocity and amplitude of N. suralis ( \<42meter/second and or \< 6 mikroVolt)
- Exclusion Criteria, among others:
- Very severe diabetic peripheral neuropathy with muscular weakness of proximal leg muscles
- Neuropathy due to other reasons such as borrelia infection, HIV, hereditary, alcohol toxic, or related to history of neurotoxic drugs.
- Severe peripheral artery disease Fontaine stage IV
- Ulcers or gangrenous lesions of the feet
Exclusion
Key Trial Info
Start Date :
March 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03755960
Start Date
March 2 2019
End Date
April 1 2021
Last Update
April 15 2021
Active Locations (2)
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1
Charité Universitätsmedizin Campus Mitte
Berlin, Germany, 10117
2
Praxis für TCM am UKE
Hamburg, Germany, 20251