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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
5/07/2024
Date data sharing statement initially provided
5/07/2024
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
Scientific title
Investigating the accuracy of manual muscle testing to distinguish congruent from incongruent statements in healthy adults, using different levels of blinding
Secondary ID [1] 279943 0
The accuracy of muscle testing
Secondary ID [2] 283766 0
The validation of kinesiology-style manual muscle testing
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Manual Muscle Testing (assessment tool)
(aka MMT) 4564 0
None. This is not a therapy, it is a noninvasive assessment tool. There is no potential harm to participants. 236995 0
Condition category
Condition code
Alternative and Complementary Medicine 4857 4857 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.)
Intervention code [1] 4327 0
Not applicable
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.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5711 0
The primary outcome will be the % of accurate tests for each level of blinding.
Timepoint [1] 5711 0
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.
Secondary outcome [1] 241630 0
mean % correct correlated with years of practitioner MMT experience
Timepoint [1] 241630 0
At the end of all data collection
Secondary outcome [2] 242393 0
mean % correct correlated with rated levels of confidence
Timepoint [2] 242393 0
Both the Practitioner and the Testee will be asked to rate their overall levels of confidence in muscle testing and in the practitioner.

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)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/02/2010
Actual
6/02/2010
Date of last participant enrolment
Anticipated
30/06/2019
Actual
15/09/2014
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
160
Accrual to date
120
Final
Recruitment outside Australia
Country [1] 1717 0
United States of America
State/province [1] 1717 0
Primarily Texas, New York, Pennsylvania
Country [2] 1718 0
United States of America
State/province [2] 1718 0
United Kingdom

Funding & Sponsors
Funding source category [1] 4752 0
Self funded/Unfunded
Name [1] 4752 0
Country [1] 4752 0
United States of America
Funding source category [2] 237147 0
Self funded/Unfunded
Name [2] 237147 0
Country [2] 237147 0
Primary sponsor type
Individual
Name
Dr. Anne M Jensen
Address
11A Whitemarsh Avenue, Erdenheim, PA 19038 USA
Country
United States of America
Secondary sponsor category [1] 4291 0
University
Name [1] 4291 0
University of Oxford
Dept of Primary Care and Dept of Continuing Professional Education
Address [1] 4291 0
Continuing Professional Development Centre
University of Oxford
Suite 1
Littlegate House
16/17 St Ebbes Street
Oxford OX1 1PT
United Kingdom
Country [1] 4291 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6795 0
Parker College of Chiropractic Institutional Review Board
Ethics committee address [1] 6795 0
Ethics committee country [1] 6795 0
United States of America
Date submitted for ethics approval [1] 6795 0
14/09/2009
Approval date [1] 6795 0
26/10/2009
Ethics approval number [1] 6795 0
Ethics committee name [2] 6940 0
OxTREC
Ethics committee address [2] 6940 0
Ethics committee country [2] 6940 0
United Kingdom
Date submitted for ethics approval [2] 6940 0
20/06/2009
Approval date [2] 6940 0
17/07/2009
Ethics approval number [2] 6940 0
OXTREC Reference Number: 34-09

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

Contacts
Principal investigator
Name 29464 0
Dr Anne M. Jensen
Address 29464 0
Wolfson College
Oxford OX2 6UD
Country 29464 0
United Kingdom
Phone 29464 0
+44 1865 600 599
Fax 29464 0
Email 29464 0
[email protected]
Contact person for public queries
Name 12711 0
Dr. Anne M Jensen
Address 12711 0
12 Highland Lake Road, Eldred, NY 12732
Country 12711 0
United States of America
Phone 12711 0
+1 323 744 7374
Fax 12711 0
none
Email 12711 0
[email protected]
Contact person for scientific queries
Name 3639 0
Dr. Anne M Jensen
Address 3639 0
11A Whitemarsh Avenue, Erdenheim, PA 19038 USA
Country 3639 0
United States of America
Phone 3639 0
+1 323 744 7374
Fax 3639 0
none
Email 3639 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseEstimating the accuracy of muscle response testing: Two randomised-order blinded studies.2016https://dx.doi.org/10.1186/s12906-016-1416-2
N.B. These documents automatically identified may not have been verified by the study sponsor.