Contact information
Type
Scientific
Primary contact
Mr Stewart Richmond
ORCID ID
Contact details
Department of Health Sciences
The University of York
Heslington
York
YO10 5DD
United Kingdom
sjr503@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CAMBRA (Copper And Magnetic Bracelets for Rheumatoid Arthritis)
Study hypothesis
The proposed trial will investigate the therapeutic effectiveness of commercially available magnet wrist straps and copper bracelets when used as an adjunct to practitioner led management of pain and inflammation in Rheumatoid Arthritis (RA). Possible effects on other major health outcomes will also be considered. This addresses a need for rigorous scientific evidence on the subject.
Ethics approval
Not provided at time of registration
Study design
Randomised, double blind, placebo controlled, trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Rheumatoid arthritis
Intervention
All participants will undergo four treatment phases each lasting for a period of five weeks in a randomised sequence. Participants will be asked to wear each of the four devices for a minimum of 12 hours per day.
Further details concerning the nature of control devices to be employed in this trial will not be released into the public domain until completion of the trial. This decision reflects the desire of the research team to maintain adequate blinding.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Pain
2. Inflammation (using acute phase reactants as proxy measures)
Secondary outcome measures
1. Physical function
2. Disease activity
3. General health
4. Quality of life
Overall trial start date
01/02/2007
Overall trial end date
01/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 18 years of age or over
2. Diagnosis of rheumatoid arthritis within medical records
3. Chronic pain: either persistent or intermittent over a minimum period of three months prior to recruitment
4. Current pain: greater than 30/100 mm on Visual Analogue Scale (VAS) within the last 24 hours despite medication
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
EStimated 60
Participant exclusion criteria
1. Pregnancy
2. Pacemaker or similar device
3. Not responsible for administering his/her own medication.
4. Dementia or memory impairment, either documented in medical records or if suspected indicated by a score of six or below on the Abbreviated Mental Test
5. Diagnosis of malignant disease within medical records
Recruitment start date
01/02/2007
Recruitment end date
01/02/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Health Sciences
York
YO10 5DD
United Kingdom
Sponsor information
Organisation
The University of York (UK)
Sponsor details
Research Support Office
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 434401
smf3@york.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
The trial is funded via a personal Researcher Development Award granted to Stewart Richmond by the UK Department of Health.
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
Basic results (scientific)
Publication list
2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18789135
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24066023
Publication citations
-
Protocol
Richmond SJ, Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA): a randomised placebo-controlled crossover trial., Trials, 2008, 9, 53, doi: 10.1186/1745-6215-9-53.
-
Results
Richmond SJ, Gunadasa S, Bland M, Macpherson H, Copper bracelets and magnetic wrist straps for rheumatoid arthritis--analgesic and anti-inflammatory effects: a randomised double-blind placebo controlled crossover trial., PLoS ONE, 2013, 8, 9, e71529, doi: 10.1371/journal.pone.0071529.