ACUDPN: ACUpuncture in Diabetic Peripheral Neuropathy

Sponsor
Benno Brinkhaus (Other)
Overall Status
Completed
CT.gov ID
NCT03755960
Collaborator
Karl and Veronica Carstens Foundation (Other)
62
2
2
25
31
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: acupuncture
  • Drug: routine care
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
multicenter, open label, randomizedmulticenter, open label, randomized
Masking:
None (Open Label)
Masking Description:
The statistician will be blinded to the study intervention.
Primary Purpose:
Treatment
Official Title:
Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.
Actual Study Start Date :
Mar 2, 2019
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. -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.

  3. Short-Form -12 (SF-12) [baseline , 8 weeks]

    12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living

  4. 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.

  5. Patient global impression of Change (PGIC) [8, 16 and 24 weeks]

    Scale from 1= very much improved to 7= very much worse

  6. 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®

  7. 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®

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charité Universitätsmedizin Campus Mitte Berlin Germany 10117
2 Praxis für TCM am UKE Hamburg Germany 20251

Sponsors and Collaborators

  • Benno Brinkhaus
  • Karl and Veronica Carstens Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Benno Brinkhaus, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT03755960
Other Study ID Numbers:
  • ACUDPN
  • 1/183/18
First Posted:
Nov 28, 2018
Last Update Posted:
Apr 15, 2021
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Benno Brinkhaus, Principal Investigator, Charite University, Berlin, Germany
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2021