Condition category
Signs and Symptoms
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/01/2010
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 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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11128820

Publication citations

  1. 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.

Additional files

Editorial Notes