Evidence map›Paper›PMID 33637134›Full record

ArticleTrials2021

Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial.

J Dietzel, S Hörder, I V Habermann, G Meyer-Hamme, K Hahn, M Ortiz, S Roll, K Linde, D Irnich, M Hammes and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03755960 (Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03755960 nacompletednot on this map

Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.

TypeinterventionalSponsorBenno BrinkhausRan2019 to 2021Enrolled62ConditionsDiabetic NeuropathyArmsacupuncture, routine care
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 5 institutions in 1 country.

J DietzelInstitute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Luisenstr. 57, 10117, Berlin, Germany. Joanna.Dietzel@charite.de.ORCID http://orcid.org/0000-0003-4739-4230
S HörderInstitute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Luisenstr. 57, 10117, Berlin, Germany.
I V HabermannInstitute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Luisenstr. 57, 10117, Berlin, Germany.
G Meyer-HammeTCM-Zentrum am UKE, Breitenfelder Str. 15, 20251, Hamburg, Germany.
K HahnDepartment of Neurology with Experimental Neurology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
M OrtizInstitute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Luisenstr. 57, 10117, Berlin, Germany.
S RollInstitute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Luisenstr. 57, 10117, Berlin, Germany.
K LindeTUM School of Medicine, Institute of General Practice, Technical University of Munich, Munich, Germany.
D IrnichDepartment of Anaesthesiology, Ludwig-Maximilians University (LMU), Marchioninistraße 15, Munich, Germany.
M HammesPraxis Dr.med. Michael Hammes, Louisenstraße 27a, Homburg, Germany.
R NögelPraxis Prof. Hempen & Kollegen, Fachärztliches Zentrum, Chinesische Medizin, Akupunktur, Franz-Joseph-Straße 38, 80801, Munich, Germany.
M WullingerPraxis für chinesische Medizin, Rathausstr. 10, 83022, Rosenheim, Germany.
V WortmanPraxis für TCM, Dilherrstr. 6, 90429, Nürnberg, Germany.
J HummelsbergerInternational Society for Chinese Medicine, Munich, Germany.
S N WillichInstitute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Luisenstr. 57, 10117, Berlin, Germany.
S SchröderTCM-Zentrum am UKE, Breitenfelder Str. 15, 20251, Hamburg, Germany.
B BrinkhausInstitute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Luisenstr. 57, 10117, Berlin, Germany.
Humboldt-Universität zu Berlin · DEOrthopädische Praxis · DEUniversität Hamburg · DELudwig-Maximilians-Universität München · DETechnical University of Munich · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms.

methodsThis study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24. DISCUSSION: The results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture.

trial registrationClinicalTrials.gov NCT03755960 . Registered on 11 August 2018.

Indexed as

Acupuncture TherapyDiabetes Mellitus, Type 2Diabetic NeuropathiesGermanyHumansMulticenter Studies as TopicPain MeasurementRandomized Controlled Trials as TopicTreatment OutcomeAcupunctureChinese medicineComplementary medicinePeripheral neuropathyRandomized controlled trialType II diabetes mellitus

Identifiers

PMID33637134
PMCPMC7907791
OpenAlexW3130899686

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.