Condition category
Nervous System Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Andrew Vickers

ORCID ID

Contact details

Integrative Medicine
Memorial Sloan-Kettering Cancer Centre
1275 York Avenue
New York
10021
United States of America
+1 212 639 6556
vickersa@MSKCC.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/40/15

Study information

Scientific title

Acronym

Study hypothesis

Acupuncture is widely if inconsistently used in primary care, particularly for the treatment of pain. Migraine and headache are common conditions which incur high health, economic and social costs. There is evidence from randomised trials which suggests that acupuncture is superior to placebo in the treatment and prophylaxis of headache and migraine. We aim to conduct a 'pragmatic' randomised trial comparing the policy of 'use acupuncture' to that of 'avoid acupuncture' in 400 headache and migraine patients recruited in primary care. The acupuncture treatment will be given by appropriately trained physiotherapists.

Such a trial design aims to reflect the real world of clinical practice so as to provide a test of service as it is provided and thus ease implementation of the results. The information provided by the trial, for example, on resource use and effect sizes, will be more applicable to the NHS than that from a placebo-controlled trial. The use of chartered physiotherapists ensures high standards of clinical competence: simpler integration of the service in the NHS: established channels for inter-disciplinary liaison and appropriate treatment, especially in cases where acupuncture might not be appropriate. Our overall question will be: what are the effects of an acupuncture service provided by physiotherapists in primary care on pain, well-being, days off work and resource use in patients with migraine or 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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Headache and migraine

Intervention

1. Acupuncture
2. Standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain, well being, days off work and resource use

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/10/1998

Overall trial end date

31/05/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Headache and migraine patients in primary care

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

401

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/10/1998

Recruitment end date

31/05/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Integrative Medicine
New York
10021
United States of America

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15023828

Publication citations

  1. Results

    Vickers AJ, Rees RW, Zollman CE, McCarney R, Smith CM, Ellis N, Fisher P, Van Haselen R, Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial., BMJ, 2004, 328, 7442, 744, doi: 10.1136/bmj.38029.421863.EB.

Additional files

Editorial Notes