Condition category
Signs and Symptoms
Date applied
08/06/2005
Date assigned
29/06/2005
Last edited
11/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.gerac.de

Contact information

Type

Scientific

Primary contact

Prof Martin Tegenthoff

ORCID ID

Contact details

Bürkle de la Camp Platz 1
Bochum
44789
Germany
+49 (0)234 3026809
martin.tegenthoff@ruhr-uni-bochum.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1748

Study information

Scientific title

Acronym

Gerac-sks

Study hypothesis

The aim of the study is to evaluate the efficacy of Chinese acupuncture = TCM acupuncture (verum) in comparison to sham-acupuncture and standard therapy (drug therapy with amitriptyline) in tension-type headache.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Tension-type headache

Intervention

Chronic pain sufferers (tension-type headache) are randomly allocated to one of the three treatment groups (verum acupuncture, sham acupuncture, or established standard therapy = amitriptyline).

Intervention type

Drug

Phase

Not Specified

Drug names

Amitriptyline

Primary outcome measures

The binary endpoint is success, yes or no, 6 months after randomization. Success is defined as a reduction of the number of headache days per month of more than 50% in comparison with the number per month at baseline.

Secondary outcome measures

Pain intensity, von Korff Score, health-related quality of life (12-Item Short-Form Health Survey SF-12), Global Patient Assessment, number of adverse and severe adverse events, quality parameters e.g. the assessment of patients blindness to the mode of acupuncture (by asking the patient to guess their group assignment after the last follow up)

Overall trial start date

29/04/2002

Overall trial end date

15/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Signed informed consent, aged 18-65, diagnosis of tension-type headache according to the criteria of the International Headache Society, tension-type headaches for >6 months, at least 10 headache days per month during the last 4 weeks before randomization (completed baseline headache diary), each day is rated as a headache day if headaches persisted for at least 4 hours or if the administration of analgesics is necessary to attenuate the pain, von Korff Chronic Pain Score at least Grade I, ability to speak and read German (to understand the questionnaires and telephone interviews).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

945

Participant exclusion criteria

Additional migraines for more than 1 day per month, secondary headaches, additional chronic pain as a result of other additional diseases, prophylaxis of headaches with drugs during the last 12 months, modification of a permanent analgesic therapy, or a new cortison-therapy within the last 8 weeks before randomization, abuse of drugs or pain medication, any acupuncture treatment against tension-type headaches at any time, or previous treatment with needle-acupuncture in any other indication in the last year.

Recruitment start date

29/04/2002

Recruitment end date

15/06/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Bürkle de la Camp Platz 1
Bochum
44789
Germany

Sponsor information

Organisation

Ruhr-University Bochum (Germany)

Sponsor details

c/o Prof. Dr. H.J. Trampisch
Universitaetsstr. 150
Bochum
44780
Germany
+49 (0)234 3227790
hans.j.trampisch@ruhr-uni-bochum.de

Sponsor type

University/education

Website

http://www.amib.ruhr-uni-bochum.de/

Funders

Funder type

Industry

Funder name

German public health insurance providers: AOK, BKK, IKK, Bundesknappschaft, Bundesverband der Landwirtschaftlichen Krankenkassen, and Seekasse (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

Publication citations

Additional files

Editorial Notes