Validation of weak magnets as a credible placebo in trials of magnetic therapies

ISRCTN	ISRCTN70945668
DOI	https://doi.org/10.1186/ISRCTN70945668
Secondary identifying numbers	N0100168711

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 21/07/2008

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Colin Greaves
Scientific

Wyndham House Surgery
Silverton
EX5 4HZ
United Kingdom

Phone	+44 (0)1392 860034
Email	c.j.greaves@exeter.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	1. To determine whether magnetic bracelets of 50mT field strength (at the ventral wrist-facing surface) are sufficiently convincing placebos for use in future trials of magnetic bracelets. The null hypothesis is that the proportion of people believing a bracelet is magnetic will be the same for people given (and allowed to test) 50mT and 180mT bracelets. 2. A secondary hypothesis relates to the difference in strength of belief that each type of bracelet may be therapeutic in relieving osteoarthritis pain.
Ethics approval(s)	Added 21 July 2008: the study protocol and procedures were submitted to N&E Devon NHS Research Ethics Committee who considered that, as study design work conducted outside any NHS setting, the study did not require formal Committee approval.
Health condition(s) or problem(s) studied	Musculoskeletal Diseases
Intervention	Randomised controlled trial, comparing belief in magnetic status between 2 groups.
Intervention type	Other
Primary outcome measure	Added 21 July 2008: Based on the magnet assigned to the participant, responses to the question "Which kind of magnet do you think you have been given?" [Active /Inactive /Dont know].
Secondary outcome measures	Added 21 July 2008: Based on the magnet assigned to the participant, responses to the question How convinced are you that wearing this bracelet on your wrist for 3 months would help to relieve pain in your joints? [visual analogue scale from 0=Not at all to 10 = Totally convinced].
Overall study start date	01/10/2005
Completion date	01/06/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	108
Key inclusion criteria	108 osteoarthritis patients who do not currently use magnetic bracelet therapy.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2005
Date of final enrolment	01/06/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wyndham House Surgery

Silverton
EX5 4HZ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

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

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Mid Devon Primary Care Trust & Mid Devon Research Group (UK)

No information available

NHS R&D Support Funding

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	01/06/2008		Yes	No