Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000395235
Ethics application status
Not yet submitted
Date submitted
13/02/2009
Date registered
2/06/2009
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect and effect mechanisms of neuromagnetic treatment for pain of knee osteoarthritis
Scientific title
Effect and effect mechanisms of neuromagnetic treatment for pain of knee osteoarthritis
Universal Trial Number (UTN)
Trial acronym
QMOAK Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the Knee 4329 0
Condition category
Condition code
Musculoskeletal 4565 4565 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Quadrapolar Neuromagnetic device, Magnetic Flux Generator(MFG), (Qmagnets tm) These consist of 4 centre charged
12 500 gauss magnets with alternating polarities that produce steep field gradients that are purported to have physiological effects. Active magnets will be applied to particpants for a one week period with a one week period wash out and one week period of wearing a placebo device. The participants will be computerized random coding system. The researcher will be blinded to active and passive device intervention.
Intervention code [1] 4058 0
Treatment: Devices
Comparator / control treatment
Placebo neuromagnetic device consists of nonmagnetised material the same size and weight of the active device with no magnetic field to side of application to knee. On the outside of the device a flexible bipolar magnet with no steep field gradient, yet is sufficient to hold a paper clip. This placebo has been manufactured to maintain the blind for the participant and the researcher that a 'placebo magnet' is being used. The crossover period will be one week of active devices, one week washout and one week of placebo device. Both researcher and participant will be blinded. There will be 4 devices worn for one weeke of each duration with a washout week in between. Each participant will be allocated active and placebo new neuromagnetic devices.
Control group
Placebo

Outcomes
Primary outcome [1] 237997 0
knee pain Visual Analogue scale
Timepoint [1] 237997 0
one week
Secondary outcome [1] 242131 0
knee function WOMAC knee assessment
Timepoint [1] 242131 0
one week

Eligibility
Key inclusion criteria
Mild to moderate knee osteoarthritis
Minimum age
18 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe deforming arthritis, concommitant health conditions that would effect trial results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited via posters and flyers from local clubs and community groups via phone email. They will be randomised into two groups with a double cross over. Both groups will receive the active medical device for one week, with a one week wash out period and one week placebo device period. Central randomization will be ensured using a computer-generating coding system and allocation will be concealed by a 'lucky dip' system of coded cards placed in a receptacle. Codes will match a master sheet where the experimental protocol will be recoreded. Investigator DH will be the only one having access to this master sheet.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation will be ensured by using a computer-generated coding system and participants will choose a code using a ‘lucky dip’ system of coded cards placed in a receptacle. Codes will match a master sheet upon which specific information regarding the experimental protocol will be recorded. Investigator DH will be the only person with full access to the master sheet
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4502 0
Other Collaborative groups
Name [1] 4502 0
Australian Physiotherapy Association
Country [1] 4502 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Qmagnets
Address
73 Shore St East,
Cleveland, 4163, Queensland
Country
Australia
Secondary sponsor category [1] 4064 0
University
Name [1] 4064 0
Griffith University
Address [1] 4064 0
School of Physiotherapy and Exercise Science, Parklands Drive, Southport 4222 Queensland
Country [1] 4064 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6562 0
Ethics committee address [1] 6562 0
Ethics committee country [1] 6562 0
Date submitted for ethics approval [1] 6562 0
13/02/2009
Approval date [1] 6562 0
Ethics approval number [1] 6562 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29287 0
Address 29287 0
Country 29287 0
Phone 29287 0
Fax 29287 0
Email 29287 0
Contact person for public queries
Name 12534 0
Dianne Hermans
Address 12534 0
73 Shore St East,
Cleveland, Queenaland 4163
Country 12534 0
Australia
Phone 12534 0
+61414398420
Fax 12534 0
+617 3821 7400
Email 12534 0
[email protected]
Contact person for scientific queries
Name 3462 0
Dianne Hermans
Address 3462 0
73 Shore St East,
Cleveland, Queensland 4163
Country 3462 0
Australia
Phone 3462 0
+61414398420
Fax 3462 0
+617 38217400
Email 3462 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.