Condition category
Nervous System Diseases
Date applied
11/10/2004
Date assigned
11/01/2005
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes