|
ISRCTN
|
ISRCTN18518978
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Application of static magnetic fields versus copper for the relief of pain in osteoarthritis: a randomised double-blind placebo controlled trial
|
|
Scientific title
|
|
|
Acronym
|
MACROPOD (Magnetic And Copper therapy for the Relief Of Pain in Osteoarthritis: a randomised Double-blind placebo-controlled trial)
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
This trial aims to investigate the therapeutic efficacy of commercially available magnetic and copper bracelets as an adjunct to practitioner led management of osteoarthritic pain.
Additional aims are to evaluate the potential economic impact of static magnetic therapy (SMT) and to gather evidence relating to safety of the devices under investigation.
This will help to address both local and more widespread needs in terms of providing rigorous scientific evidence relating to the efficacy of magnetic and copper bracelets.
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised double-blind placebo controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Osteoarthritis
|
|
Participants - inclusion criteria
|
1. 18 years of age or over
2. Diagnosis of osteoarthritis
3. In receipt of prescribed non-steroidal anti-inflammatory drugs (NSAIDs) and opioid/opioid compound analgesic medication
4. Responsible for administering own medication
5. Reporting pain associated with osteoarthritis
|
|
Participants - exclusion criteria
|
1. Confounding medical condition/disease
2. Pain lasting less than 6 weeks in total duration prior to recruitment
3. Pacemaker, insulin pump or similar device fitted
4. Pregnant women
|
|
Anticipated start date
|
01/01/2005
|
|
Anticipated end date
|
31/12/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
Trial participant information is available on http://www.hull.ac.uk/macropod/info.htm
|
|
Target number of participants
|
Between 48 to 60 patients identified as suffering from osteoarthritis within primary care.
|
|
Interventions
|
The trial will use a randomised double-blind placebo controlled crossover design. All participants will undertake one of four randomly allocated treatment sequences consisting of four phases (one active and three control). During the active phase participants will wear the MagnaMax® static magnetic device for a period of four weeks. During the three control (placebo) phases, which will each last for four weeks, all participants will in turn wear: an otherwise identical low strength static magnetic device, a demagnetised device and a copper bracelet.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Wolds Primary Care Research Network (WOREN) and West Hull Primary Care Trust (uk)
|
|
Trial website
|
http://www.hull.ac.uk/macropod/
|
|
Publications
|
|
|
Contact name
|
Mr
Stewart
Richmond
|
|
Address
|
301 Hertford Building
The University of Hull
Cottingham Road
|
|
City/town
|
Hull
|
|
Zip/Postcode
|
HU6 7RX
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1482 463681
|
|
Fax
|
+44 (0)1482 464174
|
|
Email
|
s.j.richmond@hull.ac.uk
|
|
Sponsor
|
The University of Hull (UK)
|
|
Address
|
Cottingham Road
|
|
City/town
|
Hull
|
|
Zip/Postcode
|
HU6 7RX
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1482 463681
|
|
Fax
|
+44 (0)1482 464174
|
|
Email
|
s.j.richmond@hull.ac.uk
|
|
Sponsor website:
|
http://www.hull.ac.uk
|
|
Date applied
|
15/10/2004
|
|
Last edited
|
18/12/2007
|
|
Date ISRCTN assigned
|
06/12/2004
|
