Clinical trial NCT03755960: ACUpuncture in Diabetic Peripheral Neuropathy
Official title: Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy
Keywords: acupuncture
peripheral neuropathy
diabetes mellitus type II
neurophysiology
nerve conduction velocity
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Karl and Veronica Carstens Foundation
First posted: 2018-11-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, open label, randomized
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue Scale (VAS) general complaints and pain
timeFrame: 8 weeks
Secondary outcomes:
measure: neuropathic pain symptom inventory (NPSI )
timeFrame: average of last 24h at baseline, 8, 16, 24 weeks
measure: -diabetic peripheral neuropathic pain Impact measure (DPNPI)
timeFrame: average of last week at baseline, 8, 16, 24 weeks
measure: Short-Form -12 (SF-12)
timeFrame: baseline , 8 weeks
measure: pain perception Scale (SES german)
timeFrame: latest average at 8, 16, 24 weeks
measure: Patient global impression of Change (PGIC)
timeFrame: 8, 16 and 24 weeks
measure: neurophysiological assessment of Nervus Suralis nerve conduction velocity
timeFrame: baseline, 8,16 and 24 weeks
measure: neurophysiological assessment of Nervus Suralis height of amplitude of action potential
timeFrame: baseline, 8,16 and 24 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Campus Mitte
city: Hamburg
country: Germany
facility: Praxis für TCM am UKE
Study officials:
affiliation: Charite University, Berlin, Germany
name: Benno Brinkhaus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.ctim.2006.09.005. Epub 2006 Oct 30.
citation: Schroder S, Liepert J, Remppis A, Greten JH. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol. 2007 Mar;14(3):276-81. doi: 10.1111/j.1468-1331.2006.01632.x.
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.
citation: Dietzel J, Horder S, Habermann IV, Meyer-Hamme G, Hahn K, Ortiz M, Roll S, Linde K, Irnich D, Hammes M, Nogel R, Wullinger M, Wortman V, Hummelsberger J, Willich SN, Schroder S, Brinkhaus B. Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial. Trials. 2021 Feb 26;22(1):164. doi: 10.1186/s13063-021-05110-1.