ACUpuncture in Diabetic Peripheral Neuropathy

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

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.

Official Title
-----------------
Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.

Conditions
-----------------
Diabetic Neuropathy

Intervention / Treatment
-----------------
* Procedure: acupuncture
* Drug: routine care


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicenter, open label, randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture plus routine care<br>12 session of semistandardized acupuncture together with pharmacological routine care | Procedure: acupuncture<br>* semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks<br>Drug: routine care<br>* pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)<br>|
| Active Comparator: routine care alone<br>pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs) | Drug: routine care<br>* pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropathic pain symptom inventory (NPSI ) | neuropathic pain symptom inventory- subdimensions of neuropathic pain are assessed in 10 of 11 Point numeric rating scales(NRS) | 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. | 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 | 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. | latest average at 8, 16, 24 weeks | 
| Patient global impression of Change (PGIC) | Scale from 1= very much improved to 7= very much worse | 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® | 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® | baseline, 8,16 and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, peripheral neuropathy, diabetes mellitus type II, neurophysiology, nerve conduction velocity