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Trial registered on ANZCTR


Registration number
ACTRN12620000136909p
Ethics application status
Submitted, not yet approved
Date submitted
2/12/2019
Date registered
11/02/2020
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Reliability, validity and responsiveness of chiropractic assessment techniques.
Scientific title
Reliability, validity and responsiveness of compressive prone leg check and sacral leg check for the assessment of vertebral subluxations.
Secondary ID [1] 299920 0
Nil Known
Universal Trial Number (UTN)
U1111-1243-5547
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vertebral subluxation 315349 0
Condition category
Condition code
Musculoskeletal 313652 313652 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 313812 313812 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves a single experimental session. The reliability and validity of the two chiropractic analytical tests will be assessed first. Following recruitment and screening, eligible participants will be assessed by two chiropractors using two analytical techniques: compressive prone leg check and sacral leg check. Compressive prone leg check and sacral leg check ascertain the site of vertebral subluxation by evaluating leg length inequality (LLI) and sacral restriction, respectively. Compressive prone leg check involves determining the relative position of the feet in two prone lying positions: knees straight and knees bent to 90 degrees. The sacral leg check involves comparing how high the participant raises each leg in a prone lying position with knees straight and noting the difference. Both the chiropractors will record the outcomes of these assessment tests on separate data collection sheets. The findings of each test will be compared between the two chiropractors to determine the reliability of the tests. The findings will also be compared to automated, computer-based video analysis to establish the validity of the tests. The computer-based video analysis will involve the use of a three-dimensional motion analysis system to record the position and movement of reflective markers placed on the participant's body. To determine whether the compressive prone leg check and sacral leg check are responsive to change caused by a chiropractic intervention, the participants detected with a vertebral subluxation will be randomised to receive either intervention or control intervention. The intervention will be a full spine adjustment session using an activator method technique protocol. The activator method is a standard chiropractic technique protocol that uses a small hand-held spring-loaded instrument called the Activator adjusting instrument to deliver fast, precise and low-force adjustments to the spine. A spinal adjustment is a form of manual therapy which often involves a high-velocity, low-amplitude thrust, which may induce an audible release of the joint. The single spinal adjustment intervention will take five minutes on average. The purpose of having the intervention group is to induce a change in the group, such that the responsiveness of the analytical techniques to detect that change can be evaluated in comparison to computer-based video analysis. Therefore, after the intervention, the participants will be re-assessed by one of the chiropractors using the compressive prone leg check and sacral leg check. Post-intervention computer-based video analysis will also be undertaken. The pre-post change in vertebral subluxation detected by the computer-based video analysis system will then be compared with pre-post change identified by the two analytical techniques. This will be used to determine the responsiveness of the analytical techniques.
Intervention code [1] 316193 0
Treatment: Other
Intervention code [2] 316301 0
Rehabilitation
Comparator / control treatment
The control intervention will involve using an activator instrument that has been deactivated, with the contact point being areas of the spine that are not deemed to be subluxated. The instrument will be de-activated by unloading the spring to produce a click sound without the delivery of any force. The contact points will be determined based on the findings of the pre-intervention assessment of vertebral subluxation using the compressive prone leg check and sacral leg check. The control intervention session will take five minutes on average. After the control intervention, the participants will be re-assessed by one of the chiropractors and the computer-based video analysis system. The pre-post assessments will be compared between the chiropractor and the computer-based video analysis.
Control group
Placebo

Outcomes
Primary outcome [1] 322097 0
Inter-rater reliability of compressive prone leg check will be assessed by comparing visual judgment of LLI between examiners for each participant. The possible judgements are less than 4mm difference between legs, left leg more than 4mm short or right leg more than 4mm short.
Timepoint [1] 322097 0
Immediately before the intervention.
Primary outcome [2] 322098 0
Concurrent validity of compressive prone leg check will be assessed by comparing each examiner’s visually estimated LLI to automated, computer-based video analysis. Customised scripts and programmes will be designed to enhance the accuracy of the computer-based video analysis of LLI.
Timepoint [2] 322098 0
Immediately before the intervention.
Primary outcome [3] 322309 0
Inter-rater reliability of sacral leg check will be assessed by comparing the visual judgement of sacral restriction between examiners for each participant. The possible judgements are: negative result (less than 5cm discrepancy in the height of heel elevation), restricted on the left, and restricted on the right.
Timepoint [3] 322309 0
Immediately before the intervention.
Secondary outcome [1] 377325 0
Cephalad force vs side of LLI will be assessed by comparing the difference in cephalad force between feet with the LLI. The cephalad force will be recorded by pressure-sensitive gloves worn by the chiropractors during the compressive prone leg check.
Timepoint [1] 377325 0
Immediately before the intervention.
Secondary outcome [2] 377326 0
Sacral forces will be assessed by comparing the difference in downward force over the sacrum with the sacral restriction. The downward force will be recorded by pressure-sensitive gloves worn by the chiropractors during the sacral leg check.
Timepoint [2] 377326 0
Immediately before the intervention.
Secondary outcome [3] 377327 0
Responsiveness will be assessed by comparing the changes in the pre-post assessments based on video analysis in adjusted participants in the intervention group compared to those in the control group.
Timepoint [3] 377327 0
Pre-Intervention (immediately before the intervention) and post-intervention (immediately after the intervention).
Secondary outcome [4] 378031 0
Primary Outcome [4]: Concurrent validity of the sacral leg check will be assessed by comparing each examiner’s visually estimated level of heel elevation discrepancy to automated, computer-based video analysis. Customised scripts and programmes will be designed to enhance the accuracy of the computer-based video analysis of sacral restriction.
Timepoint [4] 378031 0
Immediately before the intervention.

Eligibility
Key inclusion criteria
All adults over the age of 18 years who volunteer to participate will be eligible. Participants may include students, staff, faculty, and patients of the College’s Chiropractic Centre and also family, friends and acquaintances of the New Zealand College of Chiropractic community. However, to evaluate the responsiveness of compressive prone leg check and sacral leg check, only participants with vertebral subluxations will be randomised to the intervention or control group.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they have any predisposing factors that interfere with the conduct of the leg and sacral check (e.g. inability to lie prone or have their knees flexed comfortably to 90 degrees, extend or flex their lower limb, lower limb amputation or other lower limb trauma). They will also be excluded if they have received a chiropractic adjustment in the previous seven days or if any red flag is present.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of eligible participants to examiner order and intervention group will be carried out using an online randomisation programme This will be held by a third party. Allocation to groups will remain concealed until after the reliability assessment has taken place.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be created using Minimizer (Microsoft Corp., Redmond, WA) with a 1:1 allocation to examiner order and intervention or control intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
All participants will first be exposed to the two assessment techniques for the evaluation of reliability and validity. From total sample, only those detected with vertebral subluxations will be randomly assigned to either intervention or control group.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
To test for inter-examiner reliability and concurrent validity, a minimum sample size of at least n=50 will allow for the capture of the desired cohen's kappa of at least 0.4 with an alpha of 0.05 and beta of 0.20.
Cohen’s Kappa will be used to calculate the agreement between examiners. Pearson’s correlation coefficients will used to determine the validity and co-relation of findings with amount of pressure, A one-way ANOVA will be used to assess for mean differences in pre-post assessments.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22149 0
New Zealand
State/province [1] 22149 0
Auckland

Funding & Sponsors
Funding source category [1] 304382 0
University
Name [1] 304382 0
NewZealand College of chiropractic
Address [1] 304382 0
6 Harrison road
Ellerslie
1060,Auckland
Country [1] 304382 0
New Zealand
Funding source category [2] 304399 0
Charities/Societies/Foundations
Name [2] 304399 0
Australian Spinal Research Foundation
Address [2] 304399 0
PO Box 384
Collins Street West
VIC 8007
Country [2] 304399 0
Australia
Primary sponsor type
University
Name
New Zealand College of Chiropractic
Address
6 Harrison road
Ellerslie
1060,Auckland
Country
New Zealand
Secondary sponsor category [1] 304658 0
None
Name [1] 304658 0
Address [1] 304658 0
Country [1] 304658 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304820 0
Health and Disability Ethics Committees
Ethics committee address [1] 304820 0
Health and Disability Ethics Committees
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 304820 0
New Zealand
Date submitted for ethics approval [1] 304820 0
27/11/2019
Approval date [1] 304820 0
Ethics approval number [1] 304820 0

Summary
Brief summary
Tests of leg length inequality and sacral function are an integral component of many chiropractic analytical techniques. However, little is known about the reliability, validity and responsiveness of individual tests that include leg length testing or sacroiliac joint motion. This study will evaluate the psychometric properties of compressive prone leg check or the sacral leg check. This will include an assessment of the reliability, validity and responsiveness of these tests, and an assessment of whether the pressure placed on the patient's feet or the sacrum during the testing influences the results of the tests. The results of this study should be of interest to chiropractors and educators who routinely use and teach the use of this test as a means of analysing for vertebral subluxations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98310 0
Dr Kelly Holt
Address 98310 0
New Zealand College of Chiropractic
6 Harrison Road
Ellerslie
Auckland
1060
Country 98310 0
New Zealand
Phone 98310 0
+64 95266789
Fax 98310 0
Email 98310 0
kelly.holt@nzchiro.co.nz
Contact person for public queries
Name 98311 0
Dr Kelly Holt
Address 98311 0
New Zealand College of Chiropractic
6 Harrison Road
Ellerslie
Auckland
1060
Country 98311 0
New Zealand
Phone 98311 0
+64 95266789
Fax 98311 0
Email 98311 0
kelly.holt@nzchiro.co.nz
Contact person for scientific queries
Name 98312 0
Dr Kelly Holt
Address 98312 0
New Zealand College of Chiropractic
6 Harrison Road
Ellerslie
Auckland
1060
Country 98312 0
New Zealand
Phone 98312 0
+64 95266789
Fax 98312 0
Email 98312 0
kelly.holt@nzchiro.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results