Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000380392
Ethics application status
Approved
Date submitted
26/06/2008
Date registered
1/08/2008
Date last updated
19/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of attention re-training in pain tolerance
Scientific title
The role of attention re-training on pain tolerance in adults 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 3318 0
Condition category
Condition code
Musculoskeletal 3478 3478 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the active attention retraining task, the participants’ attention will be directed towards neutral stimuli and away from pain stimuli (affective, disability, threat and sensory pain words). The task will be administered via a computer program, and participants are required to press one of two keys in order to measure their reaction time towards the pain stimuli and neutral stimuli. The attention retraining task takes approximately 25-30 minutes to complete, which includes time for breaks of one minute intervals between trials. The attention retraining task will be administered to each participant on one occasion only, before their session with their physiotherapist.
Intervention code [1] 3057 0
Prevention
Comparator / control treatment
In the placebo attention retraining condition, the participants’ attention will be directed equally to both pain stimuli and neutral stimuli, and as such is thought to have no impact upon the participants’ outcomes. The placebo attention retraining task is also 25-30 minutes in duration. The placebo attention retraining task will be administered to each participant on one occasion only, before their session with their physiotherapist.
Control group
Placebo

Outcomes
Primary outcome [1] 4382 0
Development of chronic pain and related disability and distress. This outcome will be assessed by using the Depression Anxiety and Stress Scales (DASS; Lovibond & Lovibond, 1995), the Tampa Kinesiophobia Questionnaire (Tampa; Vlaeyen et al., 1995), the catastrophizing sub-scale of the Pain Responses Self-Statement Scale (PRSS-Cat; Flor et al., 1993), as well as the Roland Morris Disability Questionnaire (RMDQ; Roland & Morris, 1983). They will also be asked to rate their highest pain level and their average pain level during the past three or six month period on a visual analogue scale. Finally, a telephone interview will also be conducted at each of these time points in order to determine the nature of the participant's pain, whether they are taking any pain medications or have seen a health care provider for their pain, and their current work status. The results obtained at three, six and 12 months will be compared to initial measures, and in particular the outcome measure sof participants who received the active attention re-training will be compared to those who received the placebo attention retraining, in order to assess the effectiveness of the intervention. That is, does exposure to the active attention retraining task prevent the develop of chronic low back pain?
Timepoint [1] 4382 0
Participants will be followed up at three, six and 12 months after their initial assessment
Secondary outcome [1] 7395 0
Attentional bias using the dot probe computer task
Timepoint [1] 7395 0
The impact of the attention retraining tasks upon attentional bias is measured at the initial assessment point. Attention bias is measured, then the attention retraining task delivered, and then attention bias is re-measured.

Eligibility
Key inclusion criteria
Acute low back pain (less than three months duration)
First contact with physiotherapist for treatment of this acute low back pain episode
Fluent in English
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of chronic pain (three months or longer duration)
Current medical or mental illness

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be identified and enrolled by their treating physiotherapist, who will be unaware of the condition to which the participant will be allocated. Allocation to treatment condition will be by central randomization by computer at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization was used; this was done via the Randomizer program: www.randomizer.org
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3522 0
Government body
Name [1] 3522 0
Australian Research Council (ARC)
Country [1] 3522 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Louise Sharpe
Address
School of Psychology
University of Sydney
Brennan MacCallum Building A18
Camperdown
NSW 2006
Country
Australia
Secondary sponsor category [1] 3161 0
None
Name [1] 3161 0
Address [1] 3161 0
Country [1] 3161 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5560 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 5560 0
Office of Ethics Administration
Level 3, Room 313
Old Teachers? College (A22)
The University of Sydney, NSW, 2006.
Ethics committee country [1] 5560 0
Australia
Date submitted for ethics approval [1] 5560 0
Approval date [1] 5560 0
Ethics approval number [1] 5560 0
06-2006/4/9166

Summary
Brief summary
The research aims to test the leading theory of chronic pain, and to develop and test interventions aimed to reduce chronic pain. We will measure attentional biases to pain-related stimuli, such as hypervigilance (selectively paying more attention) and difficulty disengaging, in a group of adults with acute low back pain. We will then compare the effect of an active and placebo attention retraining task on these attentional biases, and the subsequent effects on the development of chronic low back pain and associated disability and distress.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28704 0
Address 28704 0
Country 28704 0
Phone 28704 0
Fax 28704 0
Email 28704 0
Contact person for public queries
Name 11861 0
Dr Kathryn Nicholson Perry
Address 11861 0
School of Psychology
University of Sydney
Brennan MacCallum Building A18
Camperdown
NSW 2006
Country 11861 0
Australia
Phone 11861 0
02 9351 4558
Fax 11861 0
Email 11861 0
[email protected]
Contact person for scientific queries
Name 2789 0
Dr Kathryn Nicholson perry
Address 2789 0
School of Psychology
University of Sydney
Brennan MacCallum Building A18
Camperdown
NSW 2006
Country 2789 0
Australia
Phone 2789 0
02 9351 4558
Fax 2789 0
Email 2789 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
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