Condition category
Injury, Occupational Diseases, Poisoning
Date applied
05/02/2019
Date assigned
18/02/2019
Last edited
18/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
The aim of this study is to measure cellular mechanisms before and after acupuncture treatment in patients with traumatic spinal cord injuries. The cellular mechanisms measured are possibly responsible for regeneration of the spinal cord.

Who can participate?
Patients aged 18-60 with traumatic spinal cord injuries

What does the study involve?
Participants undergo 15 acupuncture treatments consisting of the manual stimulation of 11 acupuncture points. Before and after each treatment blood samples are taken. Also, before the first and after the last acupuncture, neurological functions are tested by experienced examiners and classified according to the American Spinal Injury Association. Their quality of life is monitored with a standardized questionnaire.

What are the possible benefits and risks of participating?
Benefits are acupuncture treatments and two additional neurological examinations. Risks include local bruising due to acupuncture needles and taking blood samples. Changes in blood pressure may occur.

Where is the study run from?
Patients were recruited in Bayreuth and Erlangen, blood analyses are performed in Berlin, Ludwigshafen and Mannheim, Germany.

When is the study starting and how long is it expected to run for?
September 2010 to March 2015

Who is funding the study?
The study was funded by the German Medical Association for Acupuncture and the Chinese Scientific Council

Who is the main contact?
1. Dr Sonja Moldenhauer
sonja.moldenhauer@gmx.de
2. Dr Anja Moldenhauer
anja.moldenhauer@uni-saarland.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anja Moldenhauer

ORCID ID

Contact details

Moorenstr. 5
Düsseldorf
40225
Germany
+49 211 8119544
anja.moldenhauer@uni-saarland.de

Type

Public

Additional contact

Dr Sonja Moldenhauer

ORCID ID

Contact details

Dompfaffstr. 123
Erlangen
91056
Germany
+49 9131 42711
sonja.moldenhauer@gmx.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2009/112

Study information

Scientific title

Acupuncture-induced mobilization of CD133(+) 34(-) neuroprogenitors in patients with spinal cord injuries

Acronym

AIMNP

Study hypothesis

Manual acupuncture induces an increase of neuroprogenitors in patients with spinal cord injuries leading to a clinical improvement.

Ethics approval

2007: Charité - Univeristätsmedizin Berlin EA2/095/2007
2008: Ethics Committee of the Bavarian Medical Chamber Munich, 7/08111

Study design

Pilot single-center non-controlled non-randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Spinal cord injuries

Intervention

Four patients were treated 15 times with manual acupuncture twice per week over a period of 2 months. Before and after each acupuncture, differential blood counts, the number of CD133(+)34(-) and CD34(+) cells as well as CD14(+) and CD4(+) cells, brain-derived neurotrophic factor (BDNF) and matrix metalloproteinase (MMP) 9 concentrations were determined. Before and after the treatment period ASIA scores were determined to assess sensor and motor functions and their quality of life was assessed.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Mobilization of CD133(+)34(-) cells) measured by flow cytometry of whole blood before and after each acupuncture treatment (30 times per patient)

Secondary outcome measures

Before the first (baseline) and after the last acupuncture (15th):
1. Quality of life measured by SF-36
2. Clinical changes measured by ASIA scores

Overall trial start date

01/09/2010

Overall trial end date

15/03/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Spinal cord injuries for at least 6 months, ASIA score A

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4

Participant exclusion criteria

Need for mechanical ventilation and history of stroke, transient ischemic attack, epilepsy, Parkinson’s disease, multiple sclerosis, bleeding diathesis, cardiovascular diseases, severe diabetes, fever, chronic diarrhea, or severe mental disorders during the preceding 6 months

Recruitment start date

01/10/2011

Recruitment end date

11/03/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Charite - Universitätsmedizin Berlin
Department of Psychiatry and Psychotherapy Charitéplatz 1
Berlin
10117
Germany

Trial participating centre

Klinikum der Stadt Ludwigshafen
Institute for Hemostaseology and Transfusion Medicine Bremserstr. 79
Ludwigshafen
67063
Germany

Trial participating centre

Klinikum Hohe Warte
Department of Neurology Hohe Warte 8
Bayreuth
95445
Germany

Trial participating centre

Clinic for Acupuncture
Dompfaffstr. 123
Erlangen
91056
Germany

Trial participating centre

University of Applied Sciences Mannheim
Paul-Wittsack-Straße 10
Mannheim
68163
Germany

Sponsor information

Organisation

German Medical Acupuncture Association

Sponsor details

Würmtalstraße 54
81375 München
Munich
81375
Germany
089 7100511
wissenschaftszentrum@daegfa.de

Sponsor type

Research organisation

Website

https://www.daegfa.de

Organisation

China Scholarship Council

Sponsor details

No. 9 Chegongzhuang Ave.
Beijing
100044
China
86 10 66093900
wumingyuan@sjtu.edu.cn

Sponsor type

Government

Website

https://www.csc.edu.cn/

Funders

Funder type

Research organisation

Funder name

German Medical Acupuncture Association

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

China Scholarship Council

Alternative name(s)

CSC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

China

Results and Publications

Publication and dissemination plan

The data on healthy volunteers has already been published. The ex vivo generation of neural cells from acupuncture patients is accepted for publication. The trialists plan to publish the results in the near future.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sonja Moldenhauer (sonja.moldenhauer@gmx.de).

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20029964

Publication citations

Additional files

Editorial Notes