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ACUpuncture in Diabetic Peripheral Neuropathy (ACUDPN)

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ClinicalTrials.gov Identifier: NCT03755960
Recruitment Status : Not yet recruiting
First Posted : November 28, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
Karl and Veronica Carstens Foundation
Information provided by (Responsible Party):
Benno Brinkhaus, Charite University, Berlin, Germany

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
Diabetic Neuropathy Procedure: acupuncture Drug: routine care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicenter, 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.
Estimated Study Start Date : January 2, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. -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.

  3. Short-Form -12 (SF-12) [ Time Frame: baseline , 8 weeks ]
    12 item Quality of Life- Questionnaire - different scores for subdimensions of daily living

  4. 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.

  5. Patient global impression of Change (PGIC) [ Time Frame: 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 [ Time Frame: 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 [ 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®



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755960


Contacts
Contact: Benno Brinkhaus, MD, PhD +4930450529002 benno.brinkhaus@charite.de
Contact: Joanna Dietzel, MD +4930450529005 joanna.dietzel@charite.de

Locations
Germany
Charité Universitätsmedizin Campus Mitte
Berlin, Germany, 10117
Sponsors and Collaborators
Benno Brinkhaus
Karl and Veronica Carstens Foundation
Investigators
Principal Investigator: Benno Brinkhaus, MD, PhD Charite University, Berlin, Germany

Publications:
Responsible Party: Benno Brinkhaus, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03755960     History of Changes
Other Study ID Numbers: ACUDPN
1/183/18 ( Other Identifier: ethics committee )
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Benno Brinkhaus, Charite University, Berlin, Germany:
acupuncture
peripheral neuropathy
diabetes mellitus type II
neurophysiology
nerve conduction velocity

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Anticonvulsants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents