An interventional study of acupuncture and routine care in Diabetic Neuropathy, sponsored by Benno Brinkhaus. Completed at 2 sites in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by Benno Brinkhaus · Not applicable, Interventional, and Treatment
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.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 62 is close to the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →This is the only study on the registry with Benno Brinkhaus as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria, among others:
12 session of semistandardized acupuncture together with pharmacological routine care
Procedure: acupuncture · Drug: routine care
pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
Drug: routine care
semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks
pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
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
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®
Time frame: baseline, 8,16 and 24 weeks
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®
Time frame: baseline, 8,16 and 24 weeks
Plan to share: No
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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