Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000032853
Ethics application status
Not yet submitted
Date submitted
2/12/2011
Date registered
9/01/2012
Date last updated
10/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapeutic Modulation of Quiet Standing Balance
Scientific title
The effect of needle therapy applied to trigger points of the supraspinatus muscle on quiet standing balance outcomes in young healthy adults.
Secondary ID [1] 273517 0
nil
Universal Trial Number (UTN)
U1111-1126-2352
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance Disorders (vertigo, dysequilibruim) 279137 0
Condition category
Condition code
Neurological 279328 279328 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
needle puncture (acupuncture) of one myofascial trigger point located within the supraspinatus muscle bilaterally. One needle will be inserted into each trigger point (total of 2 needles). They will remain within the trigger point for 20 minutes. Only one session will be required of each subject.
Intervention code [1] 283837 0
Treatment: Other
Comparator / control treatment
Sham needle procedure. The sham needle procedure involves intramuscular needling of the normal supraspinatus muscle adjacent to the trigger point locus. The needle will remain within the trigger point for 20 minutes. Only one session will be required of each subject.
Control group
Active

Outcomes
Primary outcome [1] 285954 0
postural sway during 30 second quiet tandem-stance as measured by ground reaction forces on a force plate
Timepoint [1] 285954 0
baseline measurement prior to intervention and 10, 20 and 30 minutes post sensitization
Primary outcome [2] 285955 0
postural sway measured during 30 second quiet-tandem stance using 3-D motion analysis technology (Optotrak) tracking changes in COP and COM
Timepoint [2] 285955 0
baseline measurement prior to intervention and 10, 20 and 30 minutes post capsaicin
Secondary outcome [1] 295082 0
nil
Timepoint [1] 295082 0
nil

Eligibility
Key inclusion criteria
normal young healthy subjects
Minimum age
20 Years
Maximum age
28 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Conditions affecting normal somatosensation at the cervical spine levels including sensory or neurological disorders, vertigo/dizziness, history of falls, use of medications, acute spine injury.

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)
Subjects will be asked to provide signed informed consent before participating. Each subject will then be asked to fill out a confidential health questionnaire and undergo a physical examination of the cervical spine to identify any exclusionary conditions. Qualifying subjects will then be randomized into test or control groups by the research assistant and group allocation provided to the principal investigator of this study (Allocation is not concealed), who will perform all interventional procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by using a computer random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3946 0
Canada
State/province [1] 3946 0
ON

Funding & Sponsors
Funding source category [1] 284207 0
Self funded/Unfunded
Name [1] 284207 0
Country [1] 284207 0
Primary sponsor type
University
Name
University of Guelph
Address
50 Stone Road East
Guelph, ON
N1G 2W1
Country
Canada
Secondary sponsor category [1] 269164 0
None
Name [1] 269164 0
Address [1] 269164 0
Country [1] 269164 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286168 0
University of Guelph Research Ethics Board
Ethics committee address [1] 286168 0
Research Ethics Coordinator
Office of Research
University of Guelph
437 University Centre
Guelph, ON
N1G 2W1
Ethics committee country [1] 286168 0
Canada
Date submitted for ethics approval [1] 286168 0
30/11/2011
Approval date [1] 286168 0
Ethics approval number [1] 286168 0
11JL018

Summary
Brief summary
The purpose of this study is to investigate the therapeutic effects of needle puncture (acupuncture) of myofascial trigger points in the supraspinatus muscle in the modulation of quiet standing balance. Our thesis states that central sensitization is an important underlying mechanism in the clinical manifestation of dyequilibrium. The current literature suggests that needle puncture of myofascial trigger points modulates central sensitization and thereby has the potential to restore normal balance outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33376 0
Address 33376 0
Country 33376 0
Phone 33376 0
Fax 33376 0
Email 33376 0
Contact person for public queries
Name 16623 0
John Srbely, D.C., Ph.D.
Address 16623 0
Department of Human Health and Nutritional Sciences
Room 329A
University of Guelph
Guelph, Ontario,
N1G 2W1
Country 16623 0
Canada
Phone 16623 0
+1, 519, 824-4120 ext. 52058
Fax 16623 0
+1, 519, 763-5902
Email 16623 0
[email protected]
Contact person for scientific queries
Name 7551 0
John Srbely, D.C., Ph.D.
Address 7551 0
Department of Human Health and Nutritional Sciences
Room 329A
University of Guelph
Guelph, Ontario,
N1G 2W1
Country 7551 0
Canada
Phone 7551 0
+1, 519, 824-4120 ext. 52058
Fax 7551 0
+1, 519, 763-5902
Email 7551 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.