ACUpuncture in Diabetic Peripheral Neuropathy

Benno Brinkhaus62 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Neuropathy

Interventions

acupuncturePROCEDURE

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

routine careDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Charité Universitätsmedizin Campus Mitte

Berlin, Germany

Praxis für TCM am UKE

Hamburg, Germany

Outcomes

Primary Outcomes

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

Time frame: 8 weeks

Secondary Outcomes

neuropathic pain symptom inventory (NPSI )

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

-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.

Time frame: average of last week at baseline, 8, 16, 24 weeks

Short-Form -12 (SF-12)

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

Time frame: baseline , 8 weeks

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.

Time frame: latest average at 8, 16, 24 weeks

Patient global impression of Change (PGIC)

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

Time frame: 8, 16 and 24 weeks

neurophysiological assessment of Nervus Suralis nerve conduction velocity

measurements of nerve conduction velocity in meter per seconds (m/s)with device DPNCheck® Neurometrix®

Data from ClinicalTrials.gov

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