Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000282280
Ethics application status
Approved
Date submitted
20/03/2009
Date registered
15/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation into the predictive relationships between physical activity and recovery in a population with acute low back pain
Scientific title
An investigation into the predictive relationships between physical activity and recovery in a population with acute low back pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute low back pain 4506 0
Condition category
Condition code
Musculoskeletal 4786 4786 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Activity levels will be observed on 3 separate occasions: baseline; 3-months and 1-year. Activity levels at baseline and 3-months will be measured over a 7 day period using an RT3 triaxial accelerometer worn on the right hip, an activity diary and a 7 day activity recall questionnaire. At 1-year activity levels will be measured with the Baecke physical activity recall questionnaire. The levels and types of activities performed by each of the participants at each time point will be individually recorded and thus will differ for each participant.
Intervention code [1] 4256 0
Not applicable
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5646 0
Roland Morris Disability Questionnaire score
Timepoint [1] 5646 0
baseline, 3-months and 1-year
Primary outcome [2] 5647 0
Return to work will be assessed using a questionnaire asking the participant if they have returned to full work duties since the episode of low back pain
Timepoint [2] 5647 0
baseline, 3-months and 1-year
Primary outcome [3] 5648 0
Visual Analogue Pain Scale
Timepoint [3] 5648 0
baseline, 3-months and 1-year
Secondary outcome [1] 241535 0
Return to full normal activities will be assessed using a questionnaire asking the participant whether they consider themselves to have returned to full "normal" activities since the episode of low back pain
Timepoint [1] 241535 0
baseline, 3-months and 1-year

Eligibility
Key inclusion criteria
(1) have an episode of low back pain (LBP) of 6 weeks or less, preceded by at least 3 months of relative freedom from symptoms. (2) be between the ages of 18 and 65 years (3) have no other pre-existing conditions which limit their mobility (5) be receiving physiotherapy treatment for this current episode of acute LBP. (6) minimal score of 4 on the Roland Morris Disability Questionnaire (RMDQ).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) serious or systemic spinal pathologies including persistent or progressive neurological deficit, intractable pain, spinal surgery, or inflammatory disorders as assessed by their health practitione
(2) any history of current or past medical problems (other than LBP) which prevent them from undertaking their usual day-to-day activities.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 1694 0
New Zealand
State/province [1] 1694 0

Funding & Sponsors
Funding source category [1] 4692 0
University
Name [1] 4692 0
University of Otago
Country [1] 4692 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56, Dunedin, 9016
Country
New Zealand
Secondary sponsor category [1] 4240 0
None
Name [1] 4240 0
Address [1] 4240 0
Country [1] 4240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6730 0
Lower South Regional Ethics Committee
Ethics committee address [1] 6730 0
Ministry of Health
229 Moray Place
PO Box 5849
Dunedin, 9016
Ethics committee country [1] 6730 0
New Zealand
Date submitted for ethics approval [1] 6730 0
Approval date [1] 6730 0
07/01/2008
Ethics approval number [1] 6730 0

Summary
Brief summary
Patients with an acute episode of low back pain are normally encouraged to stay active as part of the overall management of this condition. However, little is known on how activity levels influence the course of low back pain and particularly whether staying active helps to improve rates of recovery or re-occurrence of back pain over time. The main purpose of the study is to find out whether changes in the levels and types of activities performed by participants with acute low back pain have a relationship with recovery and/or re- occurrence of low back pain over a 1-year period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29419 0
Address 29419 0
Country 29419 0
Phone 29419 0
Fax 29419 0
Email 29419 0
Contact person for public queries
Name 12666 0
Paul Hendrick
Address 12666 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin, 9016
Country 12666 0
New Zealand
Phone 12666 0
0064 3 479 5428
Fax 12666 0
Email 12666 0
[email protected]
Contact person for scientific queries
Name 3594 0
Paul Hendrick
Address 3594 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin, 9016
Country 3594 0
New Zealand
Phone 3594 0
0064 3 479 5428
Fax 3594 0
Email 3594 0
[email protected]

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.