Contact information
Type
Scientific
Primary contact
Dr Dieter Melchart
ORCID ID
Contact details
Centre for Complementary Medicine Research
Technische Universitaet Munich
Kaiserstr. 9
Munich
80801
Germany
+49 (0)89 726697 11
Dieter.Melchart@lrz.tu-muenchen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ART-TTH
Study hypothesis
Added 19/08/09:
The aim of this study is to investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache.
As of 19/08/09 this record has been updated. To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. All updates can be found under the relevant field with the above update date.
Ethics approval
Added 19/08/09: Received from local medical ethics committies
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Tension-type headache
Intervention
Acupuncture versus minimal acupuncture versus waiting list
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Added 19/08/09:
Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2002
Overall trial end date
31/08/2004
Reason abandoned
Eligibility
Participant inclusion criteria
296 patients with epidosic or chronic tension-type-headache (according to the criteria of the International Headache Society)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
296
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/03/2002
Recruitment end date
31/08/2004
Locations
Countries of recruitment
Germany
Trial participating centre
Centre for Complementary Medicine Research
Munich
80801
Germany
Sponsor information
Organisation
Munich Technical University, Centre for Complementary Medicine Research (Germany)
Sponsor details
Technische Universitaet Munich
Kaiserstr. 9
Munich
80801
Germany
+49 (0)89 726697 11
ZnF@lrz.tu-muenchen.de
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
German statutory sickness funds (Ersatzkassen) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16055451
2. 2005 treatment protocol in http://www.ncbi.nlm.nih.gov/pubmed/16430123
Publication citations
-
Results
Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K, Acupuncture in patients with tension-type headache: randomised controlled trial., BMJ, 2005, 331, 7513, 376-382, doi: 10.1136/bmj.38512.405440.8F.
-
Treatment protocol
Melchart D, Streng A, Hoppe A, Brinkhaus B, Becker-Witt C, Hammes M, Irnich D, Hummelsberger J, Willich SN, Linde K, The acupuncture randomised trial (ART) for tension-type headache--details of the treatment., Acupunct Med, 2005, 23, 4, 157-165.