ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Proportion of patients who received management

Timepoint [1]

The outcome is assessed by clinical record review.

Primary outcome [2]

(Anatomical) Spinal regions undergoing SMT

Timepoint [2]

The outcome is assessed by clinical record review.

Secondary outcome [1]

Proportion of people with whom imaging was utilised in their clinical management

Timepoint [1]

The outcome is assessed by clinical record review.

Secondary outcome [2]

(Anatomical) Location
If imaging was utilised; for what anatomical region(s)?

Timepoint [2]

The outcome is assessed by clinical record review.

Secondary outcome [3]

(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]

The outcome is assessed by clinical record review.

Secondary outcome [4]

Timing
If imaging was utilised was it acquired before or after manual care delivery?

Timepoint [4]

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

Sex

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

1/02/2012

Date of last participant enrolment

Anticipated

Actual

1/02/2012

Date of last data collection

Anticipated

1/02/2012

Actual

30/06/2012

Sample size

Target

2054

Accrual to date

Final

2054

Recruitment in Australia

Recruitment state(s)

WA

Recruitment postcode(s) [1]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

University

Name [1]

Murdoch University

Address [1]

90 South St
MURDOCH WA 6150

Country [1]

Australia

Primary sponsor type

University

Name

Murdoch University

Address

90 South St
MURDOCH WA 6150

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Murdoch University Human Research and Ethics Committee

Ethics committee address [1]

Chancellery Building
90 South St
MURDOCH WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/01/2012

Approval date [1]

30/01/2012

Ethics approval number [1]

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

Dr Lyndon Gene Amorin-Woods

Address

Murdoch University Chiropractic Clinic
Carpark 7
90 South St
MURDOCH WA 6150

Country

Australia

Phone

+61 8 93601267

Fax

Email

L.Woods@murdoch.edu.au

Contact person for public queries

Name

Lyndon Gene Amorin-Woods

Address

Murdoch University Chiropractic Clinic
Carpark 7
90 South St
MURDOCH WA 6150

Country

Australia

Phone

+61 8 93601267

Fax

Email

L.Woods@murdoch.edu.au

Contact person for scientific queries

Name

Lyndon Gene Amorin-Woods

Address

Murdoch University Chiropractic Clinic
Carpark 7
90 South St
MURDOCH WA 6150

Country

Australia

Phone

+61 8 93601267

Fax

Email

L.Woods@murdoch.edu.au

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.