Acupuncture for migraine and headache in primary care: a pragmatic, randomised trial

ISRCTN	ISRCTN96537534
DOI	https://doi.org/10.1186/ISRCTN96537534
Secondary identifying numbers	HTA 96/40/15

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 26/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Mr Andrew Vickers
Scientific

Integrative Medicine
Memorial Sloan-Kettering Cancer Centre
1275 York Avenue
New York
10021
United States of America

Phone	+1 212 639 6556
Email	vickersa@MSKCC.org

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
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(s)	Not provided at time of registration
Condition	Headache and migraine
Intervention	1. Acupuncture 2. Standard care
Intervention type	Other
Primary outcome measure	Pain, well being, days off work and resource use
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/10/1998
Overall study end date	31/05/2002

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	401
Participant inclusion criteria	Headache and migraine patients in primary care
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
United States of America

Study participating centre

Integrative Medicine

New York
10021
United States of America

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/03/2004		Yes	No