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Trial registered on ANZCTR


Registration number
ACTRN12616001315404
Ethics application status
Approved
Date submitted
15/09/2016
Date registered
20/09/2016
Date last updated
20/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapy intervention and imaging utilisation patterns for patients over the age of 50 presenting to a chiropractic teaching clinic.
Scientific title
Therapy intervention and imaging utilisation patterns for patients over the age of 50 presenting to a chiropractic teaching clinic.
Secondary ID [1] 290129 0
NIL
Universal Trial Number (UTN)
U1111-1187-4890
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Spinal Pain 300239 0
Condition category
Condition code
Musculoskeletal 300159 300159 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Clinical audit of manual care and imaging patterns
Manual care considered as chiropractic delivery of high velocity low amplitude spinal manipulation (HVLA SMT)
Imaging considered as;
Plain film radiography
CT Scan
MRI
NB: Anatomical region and geographical location acquisition specific for people managed
January 2005 to December 2010
Intervention code [1] 295880 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299588 0
Proportion of patients who received management
Timepoint [1] 299588 0
The outcome is assessed by clinical record review.
Primary outcome [2] 299661 0
(Anatomical) Spinal regions undergoing SMT
Timepoint [2] 299661 0
The outcome is assessed by clinical record review.
Secondary outcome [1] 327635 0
Proportion of people with whom imaging was utilised in their clinical management
Timepoint [1] 327635 0
The outcome is assessed by clinical record review.
Secondary outcome [2] 327753 0
(Anatomical) Location
If imaging was utilised; for what anatomical region(s)?
Timepoint [2] 327753 0
The outcome is assessed by clinical record review.
Secondary outcome [3] 327755 0
(Geographical) Location
If imaging was utilised was it acquired on campus or at another location such as a hospital or another radiology facility?
Timepoint [3] 327755 0
The outcome is assessed by clinical record review.
Secondary outcome [4] 327756 0
Timing
If imaging was utilised was it acquired before or after manual care delivery?
Timepoint [4] 327756 0
The outcome is assessed by clinical record review.

Eligibility
Key inclusion criteria
People age 50 or over presenting to a campus based chiropractic clinic
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under age 50

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Data will be analysed in IBM SPSS v22 (IBM SPSS Inc., 2010, Chicago, IL, www.spss.com), and statistical significance will be set at p<0.05.
Modelling
Frequency tables will be produced for the various clinical questions outlined.
Analysis of the whole data set may also be conducted using logistic regression.
Age will be considered as a continuous variable as well as in groupings from 50-59, 60-69, 70-79, and 80 and over.
Tables showing the odds ratios (OR) and 95% confidence intervals (CI) associated with each patient characteristic, will be produced.
The sample size was determined from a search of clinical records. Since this is an audit, 2054 is the number of cases found to fit the inclusion criteria.

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 14277 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 294504 0
University
Name [1] 294504 0
Murdoch University
Address [1] 294504 0
90 South St
MURDOCH WA 6150
Country [1] 294504 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St
MURDOCH WA 6150
Country
Australia
Secondary sponsor category [1] 293368 0
None
Name [1] 293368 0
Address [1] 293368 0
Country [1] 293368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295937 0
Murdoch University Human Research and Ethics Committee
Ethics committee address [1] 295937 0
Chancellery Building
90 South St
MURDOCH WA 6150
Ethics committee country [1] 295937 0
Australia
Date submitted for ethics approval [1] 295937 0
10/01/2012
Approval date [1] 295937 0
30/01/2012
Ethics approval number [1] 295937 0
2012/001

Summary
Brief summary
An audit of all consultations for patients 50 years and over spanning 2005-2010 was undertaken. Management of patients was categorised according to treatment delivery (yes/no); treatment type (passive care with/without SMT); spinal region (cervical/thoracic/lumbo-pelvic); whether imaging was obtained (yes/no); image timing (prior to care yes/no); and imaging centre (MUCC/external).

This study aims to quantify the imaging patterns and practices at a chiropractic teaching clinic and its significance with respect to spinal manipulation. The use of imaging within the chiropractic profession is the subject of significant debate, and especially the question of whether spinal manipulation should be performed in the absence of spinal imaging of the relevant spinal region. There has been, to date little data on the actual frequency of the use of imaging for patients undergoing chiropractic care. Whilst there is not universal agreement as to the significance of age, it does constitute an ideal starting point, a baseline to quantitatively measure imaging behaviour in a clinical setting.
This study sets out with the primary clinical question; "How often do students at a chiropractic teaching clinic view images of the region being treated with high velocity low amplitude (HVLA) manipulation of the spine if the patient is age 50 or greater?"
A second question is; "If images were viewed, were they obtained prior to HVLA treatment?"
Finally "If images were obtained, were they performed on campus or externally, or both
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 68966 0
Dr Lyndon Gene Amorin-Woods
Address 68966 0
Murdoch University Chiropractic Clinic
Carpark 7
90 South St
MURDOCH WA 6150
Country 68966 0
Australia
Phone 68966 0
+61 8 93601267
Fax 68966 0
Email 68966 0
L.Woods@murdoch.edu.au
Contact person for public queries
Name 68967 0
Dr Lyndon Gene Amorin-Woods
Address 68967 0
Murdoch University Chiropractic Clinic
Carpark 7
90 South St
MURDOCH WA 6150
Country 68967 0
Australia
Phone 68967 0
+61 8 93601267
Fax 68967 0
Email 68967 0
L.Woods@murdoch.edu.au
Contact person for scientific queries
Name 68968 0
Dr Lyndon Gene Amorin-Woods
Address 68968 0
Murdoch University Chiropractic Clinic
Carpark 7
90 South St
MURDOCH WA 6150
Country 68968 0
Australia
Phone 68968 0
+61 8 93601267
Fax 68968 0
Email 68968 0
L.Woods@murdoch.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary