ISRCTN ISRCTN97373659
DOI https://doi.org/10.1186/ISRCTN97373659
Protocol serial number N/A
Sponsor Munich Technical University, Centre for Complementary Medicine Research (Germany)
Funder German statutory sickness funds (Ersatzkassen) (Germany)
Submission date
11/10/2004
Registration date
11/01/2005
Last edited
19/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dieter Melchart
Scientific

Centre for Complementary Medicine Research
Technische Universitaet Munich
Kaiserstr. 9
Munich
80801
Germany

Phone +49 (0)89 726697 11
Email Dieter.Melchart@lrz.tu-muenchen.de

Study information

Primary study designInterventional
Study designMulticentre randomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymART-TTH
Study objectivesAdded 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(s)Added 19/08/09: Received from local medical ethics committies
Health condition(s) or problem(s) studiedTension-type headache
InterventionAcupuncture versus minimal acupuncture versus waiting list
Intervention typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/08/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration296
Key inclusion criteria296 patients with epidosic or chronic tension-type-headache (according to the criteria of the International Headache Society)
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/03/2002
Date of final enrolment31/08/2004

Locations

Countries of recruitment

  • Germany

Study participating centre

Centre for Complementary Medicine Research
Munich
80801
Germany

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 13/08/2005 Yes No
Protocol article treatment protocol 01/12/2005 Yes No