|
ISRCTN
|
ISRCTN70945668
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Validation of weak magnets as a credible placebo in trials of magnetic therapies
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0100168711
|
|
Study hypothesis
|
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
|
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.
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Musculoskeletal Diseases
|
|
Participants - inclusion criteria
|
108 osteoarthritis patients who do not currently use magnetic bracelet therapy.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/10/2005
|
|
Anticipated end date
|
01/06/2006
|
|
Status of trial
|
Completed
|
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
108
|
|
Interventions
|
Randomised controlled trial, comparing belief in magnetic status between 2 groups.
|
|
Primary outcome measure(s)
|
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 /Don’t know].
|
|
Secondary outcome measure(s)
|
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].
|
|
Sources of funding
|
Mid Devon Primary Care Trust & Mid Devon Research Group (UK)
NHS R&D Support Funding
|
|
Trial website
|
|
|
Publications
|
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18534331
|
|
Contact name
|
Dr
Colin
Greaves
|
|
Address
|
Wyndham House Surgery
|
|
City/town
|
Silverton
|
|
Zip/Postcode
|
EX5 4HZ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 01392 860034
|
|
Fax
|
+44
|
|
Email
|
c.j.greaves@exeter.ac.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
29/09/2006
|
|
Last edited
|
21/07/2008
|
|
Date ISRCTN assigned
|
29/09/2006
|