Diabetic NeuropathyACUDPNNCT03755960
ACUpuncture in Diabetic Peripheral Neuropathy
A study testing acupuncture and routine care in people with Diabetic Neuropathy, run by Benno Brinkhaus at 2 sites in Germany.
Trial summary
Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- acupuncture and routine care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesGermany
- Study dates
- 2 Mar 2019to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Germany2 sites
Charité Universitätsmedizin Campus Mitte
Berlin, 10117
Praxis für TCM am UKE
Hamburg, 20251
About this study
Official title: Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.
Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in patients with symptomatic peripheral diabetic neuropathy compared to routine care.
Read the 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.
- Conditions
- Diabetic Neuropathy
- Being tested
- acupuncture, routine care
- Keywords
- acupuncture, peripheral neuropathy, diabetes mellitus type II, neurophysiology, nerve conduction velocity
- Medical subject headings
- Diabetic Neuropathies, Peripheral Nervous System Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| acupuncture plus routine care | Experimental | 12 session of semistandardized acupuncture together with pharmacological routine care Receives: Procedure: acupuncture; Drug: routine care |
| routine care alone | Active comparator | pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs) Receives: Drug: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (7)
neuropathic pain symptom inventory (NPSI )
neuropathic pain symptom inventory- subdimensions of neuropathic pain are assessed in 10 of 11 Point numeric rating scales(NRS)
Measured: 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.
Measured: 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
Measured: 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.
Measured: latest average at 8, 16, 24 weeks
Patient global impression of Change (PGIC)
Scale from 1= very much improved to 7= very much worse
Measured: 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®
Measured: 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®
Measured: baseline, 8,16 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start2 Mar 2019
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, open label, randomized
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benno Brinkhaus
- Sponsor type
- University, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Responsible party
- Sponsor-investigator, Benno Brinkhaus, Charite University, Berlin, Germany
- Investigators
- Benno Brinkhaus, MD, PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755960
- Sponsor's protocol ID
- ACUDPN
- Other IDs
- 1/183/18
- Acronym
- ACUDPN
- Status last verified
- Sep 2020
- First submitted
- 19 Nov 2018
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18054725Schroder 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.
PubMed 17355547Witt 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.
PubMed 19420954Bolster 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.
PubMed 40890741Dietzel 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.
PubMed 33637134
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.
- ClinicalTrials.gov ID
- NCT03755960
- Acronym / sponsor ID
- ACUDPN / ACUDPN
- Conditions
- Diabetic Neuropathy
- Keywords
- acupuncture, peripheral neuropathy, diabetes mellitus type II, neurophysiology, nerve conduction velocity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Benno BrinkhausUniversity, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicenter, open label, randomized
| Arm | Type | Receives |
|---|---|---|
| acupuncture plus routine care | Experimental | Procedure: acupuncture, Drug: routine care12 session of semistandardized acupuncture together with pharmacological routine care |
| routine care alone | Active comparator | Drug: routine carepharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncturesemistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks | Procedure or surgery | acupuncture plus routine care |
| routine carepharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs) | Drug | acupuncture plus routine care, routine care alone |
Primary outcome
Visual analogue Scale (VAS) general complaints and pain
Time frame: 8 weeks
Visual analogue Scale 100mm- ranging from 0mm no symptoms/ pain to 100mm worst imaginable symptoms or pain
7 secondary outcomes
neuropathic pain symptom inventory (NPSI )
Time frame: average of last 24h at baseline, 8, 16, 24 weeks
-diabetic peripheral neuropathic pain Impact measure (DPNPI)
Time frame: average of last week at baseline, 8, 16, 24 weeks
Short-Form -12 (SF-12)
Time frame: baseline , 8 weeks
pain perception Scale (SES german)
Time frame: latest average at 8, 16, 24 weeks
Patient global impression of Change (PGIC)
Time frame: 8, 16 and 24 weeks
neurophysiological assessment of Nervus Suralis nerve conduction velocity
Time frame: baseline, 8,16 and 24 weeks
neurophysiological assessment of Nervus Suralis height of amplitude of action potential
Time frame: baseline, 8,16 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Background: PubMed 18054725Weidenhammer 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.
- Background: PubMed 17355547Schroder 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.
- Background: PubMed 19420954Witt 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.
- Derived from this study: PubMed 40890741Bolster 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.
- Derived from this study: PubMed 33637134Dietzel 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.
- Individual participant dataSharing planned: No
Related trials for Diabetic Neuropathy
Recruiting
Effects of Perturbation-Based Versus Conventional Balance Training on Reactive Stepping Ability in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Active, not recruiting
COMPARATIVE EFFECTS OF SENSORY REWEIGHTING AND PROPRIOCEPTIVE FACILITATION TRAINING ON BALANCE AND FALL RISK IN DIABETIC PERIPHERAL NEUROPATHY
Diabetic Peripheral Neuropathy (DPN)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benno Brinkhaus, MD, PhD principal investigator
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and routine care in people with Diabetic Neuropathy, run by Benno Brinkhaus at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue Scale (VAS) general complaints and pain (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03755960, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.