Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis: a randomised double blind placebo controlled trial
| ISRCTN | ISRCTN51459023 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51459023 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/09/2006
- Registration date
- 31/10/2006
- Last edited
- 27/09/2013
- 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
Mr Stewart Richmond
Scientific
Scientific
Department of Health Sciences
The University of York
Heslington
York
YO10 5DD
United Kingdom
| sjr503@york.ac.uk |
Study information
| Study design | Randomised, double blind, placebo controlled, trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CAMBRA (Copper And Magnetic Bracelets for Rheumatoid Arthritis) |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/02/2007 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | EStimated 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Health Sciences
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Sponsor information
The University of York (UK)
University/education
University/education
Research Support Office
Heslington
York
YO10 5DD
England
United Kingdom
| Phone | +44 (0)1904 434401 |
|---|---|
| smf3@york.ac.uk | |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
The trial is funded via a personal Researcher Development Award granted to Stewart Richmond by the UK Department of Health.
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/09/2008 | Yes | No | |
| Results article | results | 16/09/2013 | Yes | No |
