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Completed

NCT Number: NCT03755960

ACUpuncture in 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.

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Key information

Conditions

Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Universitätsmedizin Campus Mitte, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Procedure

semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks

Routine Care

Drug

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

Primary outcomes

  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 outcomes

  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®

Sponsors and collaborators

Lead sponsor

Benno Brinkhaus

Other

Collaborators

  • Karl and Veronica Carstens Foundation

Registry information

Official study title

Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.

Acronym: ACUDPN

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 28, 2018
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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