Trial from ANZCTR


Trial ID ACTRN12609000282280
Trial Status: Registered
Date Submitted: 20/03/2009
Date Registered: 15/05/2009
Retrospectively registered

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Public title An investigation into the predictive relationships between physical activity and recovery in a population with acute low back pain
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format An investigation into the predictive relationships between physical activity and recovery in a population with acute low back pain
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
acute low back pain 4506 0
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Condition category: Condition code:
Musculoskeletal Other muscular and skeletal disorders
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4786 4786 0 0

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Descriptions 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.
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Intervention Code:
Not applicable - Observational study 4256 0
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Comparator / control treatment No control treatment
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Control group Uncontrolled
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Primary Outcome: Roland Morris Disability Questionnaire score 5646 0
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Timepoint: baseline, 3-months and 1-year 5646 0
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Primary Outcome: 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 5647 0
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Timepoint: baseline, 3-months and 1-year 5647 0
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Primary Outcome: Visual Analogue Pain Scale 5648 0
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Timepoint: baseline, 3-months and 1-year 5648 0
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Secondary Outcome: 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 241535 0
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Timepoint: baseline, 3-months and 1-year 241535 0
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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).
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Minimum age 18 Years
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Maximum age 65 Years
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Observational
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Patient registry
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Target follow-up duration  
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Purpose Natural history
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Duration Longitudinal
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Selection Defined population
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Timing Prospective
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 16/03/2008
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 80
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

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Recruitment outside Australia

Country: New Zealand 1694 0
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State/Province: 1694 0
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Funding Source: University 4692 0
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Name: University of Otago 4692 0
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Address: PO Box 56, Dunedin, 9016 4692 0
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Country: New Zealand 4692 0
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Primary Sponsor University
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Name: University of Otago
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Address: PO Box 56, Dunedin, 9016
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Country: New Zealand
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Secondary Sponsor: None 4240 0
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Name: 4240 0
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Address: 4240 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Lower South Regional Ethics Committee 6730 0
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Address: Ministry of Health
229 Moray Place
PO Box 5849
Dunedin, 9016
6730 0
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Country: New Zealand 6730 0
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Approval Date: 07/01/2008 6730 0
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Submitted Date: 6730 0
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HREC: 6730 0
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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.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Paul Hendrick
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Address: School of Physiotherapy University of Otago PO Box 56 Dunedin, 9016
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Country: New Zealand
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Tel: 0064 3 479 5428
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Email: paul.hendrick@otago.ac.nz
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Contact person for scientific queries
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Name: Paul Hendrick
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Address: School of Physiotherapy University of Otago PO Box 56 Dunedin, 9016
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Country: New Zealand
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Email: paul.hendrick@otago.ac.nz
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Contact person responsible for updating information
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Name: Paul Hendrick
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Address: School of Physiotherapy University of Otago PO Box 56 Dunedin, 9016
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Country: New Zealand
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Tel: 0064 3 479 5428
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Email: paul.hendrick@otago.ac.nz
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Addition Cancer fields
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