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Trial registered on ANZCTR
Registration number
ACTRN12609000455268
Ethics application status
Approved
Date submitted
5/04/2009
Date registered
15/06/2009
Date last updated
23/08/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Investigating the accuracy of manual muscle testing to distinguish false from true statements, using different levels of blinding
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Scientific title
Investigating the accuracy of manual muscle testing to distinguish congruent from incongruent statements in healthy adults, using different levels of blinding
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Secondary ID [1]
279943
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The accuracy of muscle testing
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Secondary ID [2]
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The validation of kinesiology-style manual muscle testing
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Manual Muscle Testing (assessment tool)
(aka MMT)
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None. This is not a therapy, it is a noninvasive assessment tool. There is no potential harm to participants.
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Condition category
Condition code
Alternative and Complementary Medicine
4857
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This study is not testing the effectiveness of an intervention, but the accuracy of an assessment tool.
Manual Muscle Testing is an assessment tool used by an estimated 10 million practitioners worldwide. In this study the anterior deltoid muscle will be tested to see if it can withstand a given force (into extension) applied by a healthcare practitioner. During one MMT, the patient's arm will be held at 90 degrees of anterior flexion for a period not exceeding 5 seconds. Each patient will undergo no more than 30 MMTs in total over the course of about 30 minutes (i.e. 1x 5-sec MMT per minute). It is expected that one data collection session will take no more than 30 minutes.
Data collection will take place over two (2) years: September 2009 to August 2011 - or when our sample size has been acheived, whichever comes first.
It has been previously reported that a patient will not be able to resist the downward force after speaking an incongruent statement, and can easily resist the force after speaking a congruent statement. In that study, as in this one, a congruent statement is defined as one which the patient believes is true, and an incongruent statement is one that the patients believes is false.
In this study, the patient will be asked to speak statements which are true and statements which are false. In all cases, the patient will know whether the statement is true or false. However in some cases, the practitioner will be unaware if the statement spoken by the patient is true. (That is, the practitioner will be blind in some cases.) Also, in some cases, the patient will be aware that the practitioner knows that verity of the statement, and in some cases, the patient will not know if the practitioner knows the verity of the statement. (That is, in some cases, the patient will be blind to the practitioner’s blindness.)
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Intervention code [1]
4327
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Not applicable
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Comparator / control treatment
The MMT results will be compared under different levels of blinding. During some MMTs, the practitioner will be blind, and during other MMTs, the practitioner will not be blind. In all cases, blinding will be randomly determined. In addition, this study is comparing the accuracy of more experienced practitioners compared to less experienced practitioners. Finally, this study will investigate if confidence impacts the accuracy of MMT.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary outcome will be the % of accurate tests for each level of blinding.
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Assessment method [1]
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Timepoint [1]
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One entire data collection session will last no more than 30min. (See primary outcome 1 above) Data collection will take place over two (2) years: February 2010 to December 2011 - or when our sample size has been acheived, whichever comes first.
Data collection is continuing for one part of this study and will be completed by the end of 2016.
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Secondary outcome [1]
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mean % correct correlated with years of practitioner MMT experience
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Assessment method [1]
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Timepoint [1]
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At the end of all data collection
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Secondary outcome [2]
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mean % correct correlated with rated levels of confidence
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Assessment method [2]
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Timepoint [2]
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Both the Practitioner and the Testee will be asked to rate their overall levels of confidence in muscle testing and in the practitioner.
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Eligibility
Key inclusion criteria
There will be two groups of participants recruited for this study: (1) Healthcare providers ("Practitioners") who are healthy and aged between 18 and 65 years - regardless of MMT experience, and (2) "Testees" who are healthy adults between age 18 and 65 years, who the Practitioners will perform the MMT upon - they will not be assessed or measured in any way (other than the Rapport Q'aire)
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Volunteers will be excluded if they have a current physical disability or injury of their upper extremity, or are blind, deaf or mute.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Suspended
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Date of first participant enrolment
Anticipated
1/02/2010
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Actual
6/02/2010
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Date of last participant enrolment
Anticipated
30/06/2019
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Actual
15/09/2014
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Date of last data collection
Anticipated
30/06/2019
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Actual
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Sample size
Target
160
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Accrual to date
120
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Final
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Primarily Texas, New York, Pennsylvania
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Country [2]
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United States of America
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State/province [2]
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United Kingdom
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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United States of America
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Funding source category [2]
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Self funded/Unfunded
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Name [2]
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Address [2]
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Country [2]
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Primary sponsor type
Individual
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Name
Dr. Anne M Jensen
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Address
11A Whitemarsh Avenue, Erdenheim, PA 19038 USA
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Country
United States of America
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Secondary sponsor category [1]
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University
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Name [1]
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University of Oxford
Dept of Primary Care and Dept of Continuing Professional Education
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Address [1]
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Continuing Professional Development Centre
University of Oxford
Suite 1
Littlegate House
16/17 St Ebbes Street
Oxford OX1 1PT
United Kingdom
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Country [1]
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United Kingdom
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Parker College of Chiropractic Institutional Review Board
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Ethics committee address [1]
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2500 Walnut Hill Lane
Dallas, TX 75229
USA
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Ethics committee country [1]
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United States of America
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Date submitted for ethics approval [1]
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14/09/2009
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Approval date [1]
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26/10/2009
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Ethics approval number [1]
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Ethics committee name [2]
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OxTREC
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Ethics committee address [2]
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The Oxford Tropical Research Ethics Committee
Room 8, Ground Floor, Manor House
The John Radciffe, Headington
Oxford OX39DZ
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Ethics committee country [2]
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United Kingdom
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Date submitted for ethics approval [2]
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20/06/2009
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Approval date [2]
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17/07/2009
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Ethics approval number [2]
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OXTREC Reference Number: 34-09
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Summary
Brief summary
The aim of this study is to test the accuracy of manual muscle testing to distinguish congruent from incongruent statements in a group of healthcare practitioners. Manual muscle testing is an assessment tool commonly used by an estimated 2 million chiropractors and other health professionals worldwide. A total of 160 participants will be recruited: 80 from a population of healthcare practitioners ("Practitioners") and 80 "Testees" from the general population of healthy adults. The accuracy of muscle testing will be assessed on a single occasion under varying degrees of blindness.
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Trial website
None
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Trial related presentations / publications
Conference Presentations
02/05/2013 - 5th Sacro Occipital Technique Research Conference: The accuracy of kinesiology-style manual muscle testing to distinguish true spoken statements from false: The results of 2 studies of diagnostic test accuracy.
Evidence Live 2013, Oxford University, Oxford, UK, March 2012: The accuracy of kinesiology-style manual muscle testing: Three studies of diagnostic test accuracy.
05/2012 - European Chiropractors’ Union (ECU) 2012 Convention, Amsterdam, The Netherlands: The accuracy of kinesiology-style manual muscle testing to distinguish congruent from incongruent statements under varying levels of blinding: Results from a study of diagnostic test accuracy.
03/2012 - Association for Applied Psychophysiology & Biofeedback (AAPB) Annual Meeting: Is muscle testing a form of biofeedback?: Results from a study of diagnostic test accuracy.
04/2012 - World Federation of Chiropractic 11th Biennial Congress, Rio de Janeiro, Brazil: The accuracy of kinesiology-style manual muscle testing to distinguish congruent from incongruent statements under varying levels of blinding: Results from a study of diagnostic test accuracy.
03/2011 - Association of Chiropractic Colleges Research Agenda Conference, Las Vegas, Nevada, USA: The accuracy of kinesiology-style manual muscle testing: A proposed testing protocol and results from a pilot study.
Publications
Jensen, A.M., Stevens, R., Keneally, T., Stewart, J., Burls, A. (2011) “The accuracy of kinesiology-style manual muscle testing to distinguish congruent from incongruent statements under varying levels of blinding: Results from a study of diagnostic test accuracy.” Clinical Chiropractic 14(4): 157-8.
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Public notes
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Contacts
Principal investigator
Name
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Dr Anne M. Jensen
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Address
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Wolfson College
Oxford OX2 6UD
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Country
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United Kingdom
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Phone
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+44 1865 600 599
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Dr. Anne M Jensen
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Address
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12 Highland Lake Road, Eldred, NY 12732
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Country
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United States of America
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Phone
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+1 323 744 7374
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Fax
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none
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Dr. Anne M Jensen
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Address
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11A Whitemarsh Avenue, Erdenheim, PA 19038 USA
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Country
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United States of America
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Phone
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+1 323 744 7374
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Fax
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none
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Estimating the accuracy of muscle response testing: Two randomised-order blinded studies.
2016
https://dx.doi.org/10.1186/s12906-016-1416-2
N.B. These documents automatically identified may not have been verified by the study sponsor.
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