Acupuncture for episodic tension-type headache: a subject blind multi-centre randomised controlled trial (RCT)

ISRCTN	ISRCTN18207278
DOI	https://doi.org/10.1186/ISRCTN18207278
Secondary identifying numbers	C/CM/09/7.96/W

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Adrian White
Scientific

Department of Complementary Medicine
University of Exeter
CCHS
25 Victoria Park Road
Exeter
EX2 4NT
United Kingdom

Email	a.r.white@exeter.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Scientific title
Study objectives	To compare the efficacy of acupuncture with sham acupuncture for episodic tension-type headache.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Tension-type headache
Intervention	Participants received 6 weekly treatments with either standardised, brief needle acupuncture to between 4 and 8 relevant points, or sham acupuncture to non-tender points with a novel cocktail-stick placebo. Two follow-up treatments were given, 1 and 2 months later.
Intervention type	Other
Primary outcome measure	1. Number of headaches 2. Intensity measured by Visual Analogue Scale (VAS) 3. Duration of headaches 4. Number of analgesics taken Recorded by a daily headache diary
Secondary outcome measures	Not provided at time of registration
Overall study start date	03/03/1997
Completion date	03/06/1999

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50 (added 15/01/1; see publication)
Key inclusion criteria	Participants were recruited during consultation with GP, from disease registers or from notices in GP premises or local media.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	03/03/1997
Date of final enrolment	03/06/1999

Department of Complementary Medicine

Exeter
EX2 4NT
United Kingdom

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive South West (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2000		Yes	No