ACUpuncture in Diabetic Peripheral Neuropathy (ACUDPN)

Benno Brinkhaus

Status: Completed

Conditions: Diabetic Neuropathy

Treatments: Drug: routine care; Procedure: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03755960

ACUDPN

1/183/18 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

acupuncture plus routine care

Experimental group

Description:

12 session of semistandardized acupuncture together with pharmacological routine care

Treatment:

Procedure: acupuncture

Drug: routine care

routine care alone

Active Comparator group

Description:

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

Treatment:

Drug: routine care