Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001284853
Ethics application status
Approved
Date submitted
12/12/2012
Date registered
12/12/2012
Date last updated
29/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The Fear Reduction Exercised Early (FREE) approach to acute low back pain - an acceptability and utility study
Scientific title
For General Practitioners, is the Fear Reduction Exercised Early Approach to Acute Low Back Pain Acceptable and Useful
Secondary ID [1] 281657 0
Nil
Universal Trial Number (UTN)
U111111350542
Trial acronym
FREE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Low Back Pain 287943 0
Condition category
Condition code
Musculoskeletal 288324 288324 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
General Practitioners (GPs) will be instructed about current best practice for acute Low Back Pain (LBP) using a novel approach. The approach aims to assist GPs to identify and address attitudes and beliefs which may be barriers to recovery from acute LBP, explain back pain to their patients, and to provide patients with a framework which enables them to resume normal employment and activities of daily living.

GPs will be instructed about the approach during a 4 hour interactive workshop. The workshop will be supported by a booklet, a website, and a module within their electronic patient management system. The workshop will be delivered at baseline. Subsequently, GPs will receive ongoing support to use the approach via the booklet, the website. A member of the research team will visit the practices monthly during the three month duration of the trial. GPs will also be able to contact the research team as required via email and telephone.

GPs will also be provided with a novel information booklet to provide to their patients. This booklet outlines current best practice for acute LBP, supports recommendations from the GP booklet, and addresses commonly held beliefs. It encourages an active approach to managing LBP. The booklet will also be supported by a website.

GPs will try to use the intervention with patients experiencing acute low back pain for the three month duration of the trial.
Intervention code [1] 286192 0
Treatment: Other
Intervention code [2] 286197 0
Behaviour
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288494 0
Primary Outcome 1: Health Care Providers Pain and Impairment Scale (HC-PAIRS) completed by the general practitioners
Timepoint [1] 288494 0
Timepoint: at baseline, and at 3 months after intervention.
Primary outcome [2] 288495 0
Primary Outcome 2: Acceptability questionnaire (self-developed) completed by the general practitioners
Timepoint [2] 288495 0
Timepoint: at 3 months after intervention
Primary outcome [3] 288496 0
Primary Outcome 3: One-on-one semi-structured qualitative interviews with general practitioners purposively sampled based upon use of the approach.

The interviews will discuss views on the approach, the ease of application, how helpful and useful they found the resources, any difficulties which they experienced, and any barriers to implementation which they identified.
Timepoint [3] 288496 0
Timepoint: at 3 months after intervention commencement
Secondary outcome [1] 300314 0
Secondary Outcome 1: Back Pain Attitudes Questionnaire (BACK-PAQ) completed by general practitioners
Timepoint [1] 300314 0
Timepoint: at baseline, and at 3 months after intervention.
Secondary outcome [2] 300329 0
Secondary Outcome 2: workshop evaluation questionnaire (self-developed) completed by general practitioners
Timepoint [2] 300329 0
Timepoint: immediately after the workshop delivered at baseline

Eligibility
Key inclusion criteria
General Practitioner

Practice at one of two Student Health medical practices
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General Practitioners who are not expected to be employed at the Student Health medical practice for the 3 month duration of the trial

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
HC-PAIRS: the mean and standard deviation (SD) of the total score will be calculated pre- and post-intervention. The change score along with its 95% confidence interval (CI) will be calculated, and a paired t-test will be used to identify any statistically significant change, with alpha set at 0.05.

BACK-PAQ: the mean and SD of the total score will be calculated pre- and post-intervention. The change score along with its 95% CI will be calculated, and a paired t-test will be used to identify any statistically significant change, with alpha set at 0.05. The mean and SD of each of the 6 factors will also be scored pre- and post-intervention. The change scores along with their CI will be calculated, and a Wilcoxon signed-ranks test will be used to identify any statistically significant change. To correct for multiple testing in these six domains, alpha will be set at 0.01 to reduce the risk of a Type 1 error, and corresponding confidence intervals will be calculated at 99% CI. The convergent validity of the BACK-PAQ will be assessed by examining Pearson correlation coefficients of factor and total scores on the BACK-PAQ with scores on the HC-PAIRS.

Qualitative data will be analysed thematically

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/01/2013
Actual
6/01/2013
Date of last participant enrolment
Anticipated
29/03/2013
Actual
26/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4743 0
New Zealand
State/province [1] 4743 0
Wellington and Otago

Funding & Sponsors
Funding source category [1] 286452 0
Government body
Name [1] 286452 0
Lottery Health Research Committee
Country [1] 286452 0
New Zealand
Funding source category [2] 286453 0
University
Name [2] 286453 0
Physiotherapy Research Fund, School of Physiotherapy, University of Otago
Country [2] 286453 0
New Zealand
Primary sponsor type
Individual
Name
Ben Darlow
Address
Department of Primary Health Care and General Practice
University of Otago, Wellington
PO Box 7343
Wellington South, 6242
Country
New Zealand
Secondary sponsor category [1] 285241 0
None
Name [1] 285241 0
Address [1] 285241 0
Country [1] 285241 0
Other collaborator category [1] 277217 0
Individual
Name [1] 277217 0
Professor Anthony Dowell
Address [1] 277217 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
PO Box 7343
Wellington South, 6242
Country [1] 277217 0
New Zealand
Other collaborator category [2] 277218 0
Individual
Name [2] 277218 0
Professor David Baxter
Address [2] 277218 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin, 9054
Country [2] 277218 0
New Zealand
Other collaborator category [3] 277219 0
Individual
Name [3] 277219 0
Fiona Mathieson
Address [3] 277219 0
Department of Psychological Medicine
University of Otago, Wellington
PO Box 7343
Wellington South, 6242
Country [3] 277219 0
New Zealand
Other collaborator category [4] 277220 0
Individual
Name [4] 277220 0
Dr James Stanley
Address [4] 277220 0
University of Otago, Wellington
PO Box 7343
Wellington South, 6242
Country [4] 277220 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288531 0
Health and Disability Ethics Committee
Ethics committee address [1] 288531 0
Ethics committee country [1] 288531 0
New Zealand
Date submitted for ethics approval [1] 288531 0
Approval date [1] 288531 0
19/10/2012
Ethics approval number [1] 288531 0
12/CEN/49

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

Contacts
Principal investigator
Name 36550 0
Mr Ben Darlow
Address 36550 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
PO Box 7343
Wellington South, 6242
Country 36550 0
New Zealand
Phone 36550 0
+64 4 9186051
Fax 36550 0
Email 36550 0
ben.darlow@otago.ac.nz
Contact person for public queries
Name 36551 0
Ben Darlow
Address 36551 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
PO Box 7343
Wellington South, 6242
Country 36551 0
New Zealand
Phone 36551 0
+64 4 9186051
Fax 36551 0
Email 36551 0
ben.darlow@otago.ac.nz
Contact person for scientific queries
Name 36552 0
Ben Darlow
Address 36552 0
Department of Primary Health Care and General Practice
University of Otago, Wellington
PO Box 7343
Wellington South, 6242
Country 36552 0
New Zealand
Phone 36552 0
+64 4 9186051
Fax 36552 0
Email 36552 0
ben.darlow@otago.ac.nz

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
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