ACUpuncture in Diabetic Peripheral Neuropathy

Not Applicable

Completed

• Conditions: Diabetic Neuropathy
• Interventions: Procedure: acupuncture; Drug: routine care

• Registration Number: NCT03755960
• Lead Sponsor: Benno Brinkhaus

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.

Study Timeline

• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Study Start: 2019-03-02
• Status Verified: 2020-09
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture plus routine care	routine care	12 session of semistandardized acupuncture together with pharmacological routine care
acupuncture plus routine care	acupuncture	12 session of semistandardized acupuncture together with pharmacological routine care
routine care alone	routine care	pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)

Primary Outcome Measures

Name	Time	Method
Visual analogue Scale (VAS) general complaints and pain	8 weeks	Visual analogue Scale 100mm- ranging from 0mm no symptoms/ pain to 100mm worst imaginable symptoms or pain

Secondary Outcome Measures

Name	Time	Method
neuropathic pain symptom inventory (NPSI )	average of last 24h at baseline, 8, 16, 24 weeks	neuropathic pain symptom inventory- subdimensions of neuropathic pain are assessed in 10 of 11 Point numeric rating scales(NRS)
-diabetic peripheral neuropathic pain Impact measure (DPNPI)	average of last week at baseline, 8, 16, 24 weeks	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.
pain perception Scale (SES german)	latest average at 8, 16, 24 weeks	emotional component of pain -scale- max sum score of 96- the higher the score the higher the negative emotional burden of pain experience.
neurophysiological assessment of Nervus Suralis height of amplitude of action potential	baseline, 8,16 and 24 weeks	height of amplitude of action potential of N. suralis in mikroVolt (µV) with device "DPNCheck®" from Neurometrix®
neurophysiological assessment of Nervus Suralis nerve conduction velocity	baseline, 8,16 and 24 weeks	measurements of nerve conduction velocity in meter per seconds (m/s)with device DPNCheck® Neurometrix®
Short-Form -12 (SF-12)	baseline , 8 weeks	12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living
Patient global impression of Change (PGIC)	8, 16 and 24 weeks	Scale from 1= very much improved to 7= very much worse

Trial Locations

Locations (2)

Praxis für TCM am UKE; 🇩🇪 Hamburg, Germany

Charité Universitätsmedizin Campus Mitte; 🇩🇪 Berlin, Germany