ACUpuncture in Diabetic Peripheral Neuropathy

Diabetic Neuropathy Clinical Trial

— ACUDPN  

Official title:

Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755960
• Other study ID #: ACUDPN
• Secondary ID: 1/183/18
• Status: Completed
• Phase: N/A
• Start date: March 2, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: September 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care.

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 nerves are incorporated into the study as a possible morphological correlate of functional and clinical findings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Peripheral Nervous System Diseases

Intervention

Procedure:
• acupuncture
semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks

Drug:
• routine care
pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Campus Mitte	Berlin
Germany	Praxis für TCM am UKE	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Benno Brinkhaus	Karl and Veronica Carstens Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Schröder S, Liepert J, Remppis A, Greten JH. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol. 2007 Mar;14(3):276-81. — View Citation

Weidenhammer W, Streng A, Linde K, Hoppe A, Melchart D. Acupuncture for chronic pain within the research program of 10 German Health Insurance Funds--basic results from an observational study. Complement Ther Med. 2007 Dec;15(4):238-46. Epub 2006 Oct 30. — View Citation

Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue Scale (VAS) general complaints and pain	Visual analogue Scale 100mm- ranging from 0mm no symptoms/ pain to 100mm worst imaginable symptoms or pain	8 weeks
Secondary	neuropathic pain symptom inventory (NPSI )	neuropathic pain symptom inventory- subdimensions of neuropathic pain are assessed in 10 of 11 Point numeric rating scales(NRS)	average of last 24h at baseline, 8, 16, 24 weeks
Secondary	-diabetic peripheral neuropathic pain Impact measure (DPNPI)	disease- specific Quality of Life- max sum score of 95; the higher the sum-score the higher the interference of diabetic peripheral neuropathy with activities of daily living.	average of last week at baseline, 8, 16, 24 weeks
Secondary	Short-Form -12 (SF-12)	12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living	baseline , 8 weeks
Secondary	pain perception Scale (SES german)	emotional component of pain -scale- max sum score of 96- the higher the score the higher the negative emotional burden of pain experience.	latest average at 8, 16, 24 weeks
Secondary	Patient global impression of Change (PGIC)	Scale from 1= very much improved to 7= very much worse	8, 16 and 24 weeks
Secondary	neurophysiological assessment of Nervus Suralis nerve conduction velocity	measurements of nerve conduction velocity in meter per seconds (m/s)with device DPNCheck® Neurometrix®	baseline, 8,16 and 24 weeks
Secondary	neurophysiological assessment of Nervus Suralis height of amplitude of action potential	height of amplitude of action potential of N. suralis in mikroVolt (µV) with device "DPNCheck®" from Neurometrix®	baseline, 8,16 and 24 weeks