Contact information
Type
Scientific
Primary contact
Dr Adrian White
ORCID ID
Contact details
Department of Complementary Medicine
University of Exeter
CCHS
25 Victoria Park Road
Exeter
EX2 4NT
United Kingdom
a.r.white@exeter.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C/CM/09/7.96/W
Study information
Scientific title
Acronym
Study hypothesis
To compare the efficacy of acupuncture with sham acupuncture for episodic tension-type headache.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
03/03/1997
Overall trial end date
03/06/1999
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants were recruited during consultation with GP, from disease registers or from notices in GP premises or local media.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 (added 15/01/1; see publication)
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
03/03/1997
Recruitment end date
03/06/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Complementary Medicine
Exeter
EX2 4NT
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South West (UK)
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
Basic results (scientific)
Publication list
2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11128820
Publication citations
-
Results
White AR, Resch KL, Chan JC, Norris CD, Modi SK, Patel JN, Ernst E, Acupuncture for episodic tension-type headache: a multicentre randomized controlled trial., Cephalalgia, 2000, 20, 7, 632-637.