ACUpuncture in Diabetic Peripheral Neuropathy

NCT03755960 | Completed

• 2 other identifiers: ACUDPN1/183/18
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Diabetic Neuropathy

Keywords

acupuncture; peripheral neuropathy; diabetes mellitus type II; neurophysiology; nerve conduction velocity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• neuropathic pain symptom inventory (NPSI )

  average of last 24h at baseline, 8, 16, 24 weeks

• -diabetic peripheral neuropathic pain Impact measure (DPNPI)

  average of last week at baseline, 8, 16, 24 weeks

• Short-Form -12 (SF-12)

  baseline , 8 weeks

• pain perception Scale (SES german)

  latest average at 8, 16, 24 weeks

• Patient global impression of Change (PGIC)

  8, 16 and 24 weeks

Study Arms (2)

acupuncture plus routine care

EXPERIMENTAL

12 session of semistandardized acupuncture together with pharmacological routine care

Procedure: acupuncture; Drug: routine care

routine care alone

ACTIVE COMPARATOR

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

Drug: routine care

Interventions

acupuncture PROCEDURE

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

acupuncture plus routine care

routine care DRUG

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

acupuncture plus routine care; routine care alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Benno Brinkhaus: lead
• Karl and Veronica Carstens Foundation: collaborator

Study Sites (2)

Charité Universitätsmedizin Campus Mitte

Berlin, 10117, Germany

Location

Praxis für TCM am UKE

Hamburg, 20251, Germany

Location

Related Publications (5)

• Weidenhammer W, Streng A, Linde K, Hoppe A, Melchart D. Acupuncture for chronic pain within the research program of 10 German Health Insurance Funds--basic results from an observational study. Complement Ther Med. 2007 Dec;15(4):238-46. doi: 10.1016/j.ctim.2006.09.005. Epub 2006 Oct 30.

  PMID: 18054725 BACKGROUND

• Schroder S, Liepert J, Remppis A, Greten JH. Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol. 2007 Mar;14(3):276-81. doi: 10.1111/j.1468-1331.2006.01632.x.

  PMID: 17355547 BACKGROUND

• Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9.

  PMID: 19420954 BACKGROUND

• Bolster M, Dietzel J, Habermann IV, Horder S, Brinkhaus B, Stockigt B. Patients' experiences with acupuncture for diabetic polyneuropathy as part of a randomized controlled trial (ACUDPN) - a qualitative study. BMC Complement Med Ther. 2025 Sep 1;25(1):317. doi: 10.1186/s12906-025-05064-w.

  PMID: 40890741 DERIVED

• Dietzel J, Horder S, Habermann IV, Meyer-Hamme G, Hahn K, Ortiz M, Roll S, Linde K, Irnich D, Hammes M, Nogel R, Wullinger M, Wortman V, Hummelsberger J, Willich SN, Schroder S, Brinkhaus B. Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial. Trials. 2021 Feb 26;22(1):164. doi: 10.1186/s13063-021-05110-1.

  PMID: 33637134 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies; Peripheral Nervous System Diseases; Diabetes Mellitus, Type 2

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Benno Brinkhaus, MD, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistician will be blinded to the study intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: multicenter, open label, randomized

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 28, 2018
• Study Start: March 2, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 15, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)