Condition category
Musculoskeletal Diseases
Date applied
19/09/2006
Date assigned
31/10/2006
Last edited
27/09/2013
Prospective/Retrospective
Prospectively 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 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 measures

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

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

Results - basic reporting

Publication summary

2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18789135
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24066023

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes