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Trial registered on ANZCTR


Registration number
ACTRN12612000041853
Ethics application status
Not yet submitted
Date submitted
9/01/2012
Date registered
10/01/2012
Date last updated
10/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Quadripolar Magnets on Myofascial Pain Syndrome
Scientific title
The Antinociceptive Effects of Quadripolar Magnets Applied to Myofascial Trigger Points Associated With Myofascial Pain Syndrome in the Cervicothoracic Region
Secondary ID [1] 279680 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myofascial Pain Syndrome 285505 0
Condition category
Condition code
Musculoskeletal 285719 285719 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects with a clinical diagnosis of cervicothoracic regional myofascial pain syndrome (MPS) will be randomly allocated to equal test and control groups; the test group will self-apply quadripolar magnets that contain two positive and two negative poles arranged in a circle. The magnets will be self-applied on the surface of the skin directly over a clinically identified myofascial trigger point locus in the supraspinatus muscle for seven days beginning immediately upon waking in the morning and removed before retiring for the evening. Subjects will also be asked to complete a daily pain questionnaire just after removing the magnet for the evening.
Intervention code [1] 283970 0
Treatment: Devices
Comparator / control treatment
Subjects in the control group will self-apply a sham device, identical in appearance to the quadripolar magnets used in the test group. However, the sham device will have no magnetic properties and like the test device, it will be self-applied on the surface of the skin directly over a clinically identified myofascial trigger point locus in the supraspinatus muscle for seven days beginning immediately upon waking in the morning and removed before retiring for the evening. Subjects will also be asked to complete a daily pain questionnaire just after removing the magnet for the evening.
Control group
Placebo

Outcomes
Primary outcome [1] 286226 0
Participants will be asked to complete a pain questionnaire (visual analogue score) daily (days 1 - 7).
Timepoint [1] 286226 0
days 1 to 7
Secondary outcome [1] 295413 0
nil
Timepoint [1] 295413 0
nil

Eligibility
Key inclusion criteria
A clinical diagnosis of regional myofascial pain syndrome (cervicothoracic) with identifiable bilateral myofascial trigger points within the supraspinatus muscle.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
patients using an electronic medical device (eg pacemaker), acute injury to cervicothoracic spine, history of autoimmune/connective tissue disorder/spinal surgery, current use of pain/anti-inflammatory medication, neurological conditions (neuropathy).

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)
Prospective participants will be recruited from the patient roster of an outpatient medical clinic and asked to complete a confidential medical history to identify exclusion criteria. The presiding clinician will then perform a physical examination to identify trigger points in the supraspinatus muscles bilaterally. Qualifying participants will then be randomly allocated to test or control groups by the clinic research assistant using a random draw technique.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be performed using a random draw technique using labelled slips of paper (test, control) drawn from an opaque bin. The research team will be blinded to group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4043 0
Canada
State/province [1] 4043 0
Ontario

Funding & Sponsors
Funding source category [1] 284463 0
Self funded/Unfunded
Name [1] 284463 0
Country [1] 284463 0
Primary sponsor type
University
Name
University of Guelph
Address
50 Stone Road East
Guelph, Ontario
N1G2W1
Country
Canada
Secondary sponsor category [1] 283389 0
None
Name [1] 283389 0
Address [1] 283389 0
Country [1] 283389 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286444 0
University of Guelph REB
Ethics committee address [1] 286444 0
Ethics committee country [1] 286444 0
Canada
Date submitted for ethics approval [1] 286444 0
09/01/2012
Approval date [1] 286444 0
Ethics approval number [1] 286444 0

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

Contacts
Principal investigator
Name 33597 0
Address 33597 0
Country 33597 0
Phone 33597 0
Fax 33597 0
Email 33597 0
Contact person for public queries
Name 16844 0
John Srbely
Address 16844 0
Department of Human Health and Nutritional Science
University of Guelph
50 Stone Road East
Guelph, Ontario
N1G2W1
Country 16844 0
Canada
Phone 16844 0
+011-1-519-824-4120 ext 52058
Fax 16844 0
Email 16844 0
jsrbely@uoguelph.ca
Contact person for scientific queries
Name 7772 0
John Srbely
Address 7772 0
Department of Human Health and Nutritional Science
University of Guelph
50 Stone Road East
Guelph, Ontario
N1G2W1
Country 7772 0
Canada
Phone 7772 0
+011-1-519-824-4120 ext 52058
Fax 7772 0
Email 7772 0
jsrbely@uoguelph.ca

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.