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ACUpuncture in Diabetic Peripheral Neuropathy (ACUDPN)

Primary Purpose

Diabetic Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
acupuncture
routine care
Sponsored by
Benno Brinkhaus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy focused on measuring acupuncture, peripheral neuropathy, diabetes mellitus type II, neurophysiology, nerve conduction velocity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Universitätsmedizin Campus Mitte
  • Praxis für TCM am UKE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

acupuncture plus routine care

routine care alone

Arm Description

12 session of semistandardized acupuncture together with pharmacological routine care

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

neuropathic pain symptom inventory (NPSI )
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)
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.
Short-Form -12 (SF-12)
12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living
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.
Patient global impression of Change (PGIC)
Scale from 1= very much improved to 7= very much worse
neurophysiological assessment of Nervus Suralis nerve conduction velocity
measurements of nerve conduction velocity in meter per seconds (m/s)with device DPNCheck® Neurometrix®
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®

Full Information

First Posted
November 19, 2018
Last Updated
April 14, 2021
Sponsor
Benno Brinkhaus
Collaborators
Karl and Veronica Carstens Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03755960
Brief Title
ACUpuncture in Diabetic Peripheral Neuropathy
Acronym
ACUDPN
Official Title
Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Benno Brinkhaus
Collaborators
Karl and Veronica Carstens Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
Keywords
acupuncture, peripheral neuropathy, diabetes mellitus type II, neurophysiology, nerve conduction velocity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multicenter, open label, randomized
Masking
None (Open Label)
Masking Description
The statistician will be blinded to the study intervention.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture plus routine care
Arm Type
Experimental
Arm Description
12 session of semistandardized acupuncture together with pharmacological routine care
Arm Title
routine care alone
Arm Type
Active Comparator
Arm Description
pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks
Intervention Type
Drug
Intervention Name(s)
routine care
Intervention Description
pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
Primary Outcome Measure Information:
Title
Visual analogue Scale (VAS) general complaints and pain
Description
Visual analogue Scale 100mm- ranging from 0mm no symptoms/ pain to 100mm worst imaginable symptoms or pain
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
neuropathic pain symptom inventory (NPSI )
Description
neuropathic pain symptom inventory- subdimensions of neuropathic pain are assessed in 10 of 11 Point numeric rating scales(NRS)
Time Frame
average of last 24h at baseline, 8, 16, 24 weeks
Title
-diabetic peripheral neuropathic pain Impact measure (DPNPI)
Description
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.
Time Frame
average of last week at baseline, 8, 16, 24 weeks
Title
Short-Form -12 (SF-12)
Description
12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living
Time Frame
baseline , 8 weeks
Title
pain perception Scale (SES german)
Description
emotional component of pain -scale- max sum score of 96- the higher the score the higher the negative emotional burden of pain experience.
Time Frame
latest average at 8, 16, 24 weeks
Title
Patient global impression of Change (PGIC)
Description
Scale from 1= very much improved to 7= very much worse
Time Frame
8, 16 and 24 weeks
Title
neurophysiological assessment of Nervus Suralis nerve conduction velocity
Description
measurements of nerve conduction velocity in meter per seconds (m/s)with device DPNCheck® Neurometrix®
Time Frame
baseline, 8,16 and 24 weeks
Title
neurophysiological assessment of Nervus Suralis height of amplitude of action potential
Description
height of amplitude of action potential of N. suralis in mikroVolt (µV) with device "DPNCheck®" from Neurometrix®
Time Frame
baseline, 8,16 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benno Brinkhaus, MD, PhD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Praxis für TCM am UKE
City
Hamburg
ZIP/Postal Code
20251
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18054725
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.
Results Reference
background
PubMed Identifier
17355547
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.
Results Reference
background
PubMed Identifier
19420954
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.
Results Reference
background
PubMed Identifier
33637134
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.
Results Reference
derived

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ACUpuncture in Diabetic Peripheral Neuropathy

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