ACUpuncture in Diabetic Peripheral Neuropathy (ACUDPN)

April 14, 2021 updated by: Benno Brinkhaus

Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Campus Mitte
      • Hamburg, Germany, 20251
        • Praxis für TCM am UKE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acupuncture plus routine care
12 session of semistandardized acupuncture together with pharmacological routine care
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)
Active Comparator: routine care alone
pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
Drug: routine care
pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue Scale (VAS) general complaints and pain
Time Frame: 8 weeks
Visual analogue Scale 100mm- ranging from 0mm no symptoms/ pain to 100mm worst imaginable symptoms or pain
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neuropathic pain symptom inventory (NPSI )
Time Frame: 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)
average of last 24h at baseline, 8, 16, 24 weeks
-diabetic peripheral neuropathic pain Impact measure (DPNPI)
Time Frame: 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.
average of last week at baseline, 8, 16, 24 weeks
Short-Form -12 (SF-12)
Time Frame: baseline , 8 weeks
12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living
baseline , 8 weeks
pain perception Scale (SES german)
Time Frame: 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.
latest average at 8, 16, 24 weeks
Patient global impression of Change (PGIC)
Time Frame: 8, 16 and 24 weeks
Scale from 1= very much improved to 7= very much worse
8, 16 and 24 weeks
neurophysiological assessment of Nervus Suralis nerve conduction velocity
Time Frame: baseline, 8,16 and 24 weeks
measurements of nerve conduction velocity in meter per seconds (m/s)with device DPNCheck® Neurometrix®
baseline, 8,16 and 24 weeks
neurophysiological assessment of Nervus Suralis height of amplitude of action potential
Time Frame: baseline, 8,16 and 24 weeks
height of amplitude of action potential of N. suralis in mikroVolt (µV) with device "DPNCheck®" from Neurometrix®
baseline, 8,16 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benno Brinkhaus

Collaborators

Karl and Veronica Carstens Foundation

Investigators

  • Principal Investigator: Benno Brinkhaus, MD, PhD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2019

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

November 19, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACUDPN
  • 1/183/18 (Other Identifier: ethics committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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