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
Organisation
China Scholarship Council
Sponsor details
No. 9 Chegongzhuang Ave.
Beijing
100044
China
86 10 66093900
wumingyuan@sjtu.edu.cn
Sponsor type
Government
Website
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
Federal/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