Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12613000842763
Ethics application status
Approved
Date submitted
25/07/2013
Date registered
31/07/2013
Date last updated
12/05/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Walking away from Low Back Pain: The New Zealand Back to Activity Trial
Query!
Scientific title
The effectiveness of a pedometer-driven walking programme for chronic low back pain compared to standard care (direct access physiotherapy) on perceived disability.
Query!
Secondary ID [1]
282908
0
nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Low Back Pain
289720
0
Query!
Condition category
Condition code
Physical Medicine / Rehabilitation
290047
290047
0
0
Query!
Physiotherapy
Query!
Musculoskeletal
290058
290058
0
0
Query!
Other muscular and skeletal disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Participants will be randomly allocated to one of two groups: either standard care or a walking group.
Following randomisation, members of the walking group will undergo an initial physiotherapy assessment (as for standard care), and then be prescribed an individualised pedometer-driven walking programme by a trained physiotherapist. At week 1 each participant will complete a 20-step test with the physiotherapist to ensure that the pedometer is recording, and that they can use it correctly. Each participant in this group will wear a pedometer for a minimum of 5 consecutive days per week of the 8-week clinical trial; they will also record their daily steps and other activities in a diary. In the first week, patients will undertake usual daily activity without any predetermined increase in steps. At the week 2 appointment the step target for the subsequent week will be agreed between the physiotherapist and the participant by referring to (1) the mean daily step count for the previous week calculated from the walking diary, and (2) the number of steps accumulated during the 10-minute “self-efficacy walk”, which will be performed by the participant, accompanied by the physiotherapist, to demonstrate number of steps accrued in 10 minutes of walking. There will no further face-to-face appointments: between weeks 3 and 8 the physiotherapist will phone the participant at a prearranged time, each week, to discuss their progress, document their mean daily step count (recorded in diaries) for the previous week, and to agree to a new daily step target for the subsequent week. In this way the walking programme will be tailored to the individual and progressed on a weekly basis. An evidence-based approach to behavior change via promotion of activity in the community (the 5As approach: assess, advise, agree, assist, and arrange) will be adopted in order to structure the consultation between the physiotherapist and the patient, and enhance adherence to the walking programme. Adherence will be measured from the pedometer data, and calculated as a percentage of the prescribed number of steps and number of active days; participants will then be followed up after 6 and 12 months following completion of the programme.
The initial assessment and 'Week 2' appointments will be approximately 1 hour in duration.
Weekly telephone follow-up calls are anticipated to be around 30 minutes maximum duration.
Query!
Intervention code [1]
287604
0
Rehabilitation
Query!
Intervention code [2]
287612
0
Treatment: Other
Query!
Intervention code [3]
287613
0
Lifestyle
Query!
Comparator / control treatment
Standard care:
Standard care will consist of usual physiotherapy clinical care in line with current clinical practice in New Zealand: i.e. each physiotherapist will adopt a pragmatic approach, with treatment individualised to each patient, and limited to a maximum period of 8 weeks (with no specified maximum number of treatments).
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
290099
0
The Oswestry Disability Questionnaire (ODQ)
Query!
Assessment method [1]
290099
0
Query!
Timepoint [1]
290099
0
8 weeks/ 6 months/ 12 months
Query!
Secondary outcome [1]
303938
0
International Physical Activity Questionnaire (IPAQ; short form)
Query!
Assessment method [1]
303938
0
Query!
Timepoint [1]
303938
0
8 weeks/ 6 months/ 12 months
Query!
Secondary outcome [2]
303939
0
Fear-Avoidance Beliefs Questionnaire (FABQ)
Query!
Assessment method [2]
303939
0
Query!
Timepoint [2]
303939
0
8 weeks/ 6 months/ 12 months
Query!
Secondary outcome [3]
303940
0
Stage of Change: Readiness to change will be assessed using a standardised questionnaire, which describes an individual’s position in a cycle of change as described within the well-established Prochaska and Diclemente framework.
Query!
Assessment method [3]
303940
0
Query!
Timepoint [3]
303940
0
8 weeks/ 6 months/ 12 months
Query!
Secondary outcome [4]
303941
0
Back Beliefs questionnaire (BBQ)
Query!
Assessment method [4]
303941
0
Query!
Timepoint [4]
303941
0
8 weeks/ 6 months/ 12 months
Query!
Secondary outcome [5]
303942
0
Physical Activity Self-efficacy Scale
Query!
Assessment method [5]
303942
0
Query!
Timepoint [5]
303942
0
8 weeks/ 6 months/ 12 months
Query!
Secondary outcome [6]
303943
0
Global Rating of Change for physical activity (GROC)
Query!
Assessment method [6]
303943
0
Query!
Timepoint [6]
303943
0
8 weeks/ 6 months/ 12 months
Query!
Secondary outcome [7]
303944
0
Pain (Visual Analogue Scale)
Query!
Assessment method [7]
303944
0
Query!
Timepoint [7]
303944
0
8 weeks/ 6 months/ 12 months
Query!
Eligibility
Key inclusion criteria
Males and females experiencing low back pain with/without radiation, persisting for > 12 weeks, capable of participating in home-based exercise, and with fluency in English (verbal and written).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Any spinal surgery in the past 12 months; evidence of nerve root, spinal cord, or cauda equine compression, severe spinal stenosis indicated by signs of neurogenic claudication, grade 3 to 4 spondylolisthesis (grade 1 to 2 spondylolisthesis eligible for inclusion), fibromyalgia, or systemic/inflammatory disorder; any other current musculoskeletal injury or contraindication to increasing PA levels, including any cardiorespiratory or other medical condition contraindicating increased exercise; LBP caused by involvement in a road traffic accident in the last 12 months or ongoing litigation; history of serious psychological or psychiatric illness (mild depression eligible for inclusion); current pregnancy.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
24/06/2013
Query!
Actual
23/07/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
28/02/2014
Query!
Date of last data collection
Anticipated
Query!
Actual
18/05/2015
Query!
Sample size
Target
55
Query!
Accrual to date
Query!
Final
28
Query!
Recruitment outside Australia
Country [1]
5246
0
New Zealand
Query!
State/province [1]
5246
0
Otago
Query!
Funding & Sponsors
Funding source category [1]
287685
0
University
Query!
Name [1]
287685
0
University of Otago
Query!
Address [1]
287685
0
University of Otago
PO Box 56
Dunedin 9054
Query!
Country [1]
287685
0
New Zealand
Query!
Primary sponsor type
Individual
Query!
Name
Professor G. David Baxter
Query!
Address
School of Physiotherapy
University of Otago
325 Great King Street
Dunedin 9016
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
286417
0
None
Query!
Name [1]
286417
0
Query!
Address [1]
286417
0
Query!
Country [1]
286417
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
289644
0
University of Otago Human Ethics Committee
Query!
Ethics committee address [1]
289644
0
University of Otago
PO Box 56
Dunedin 9054
Query!
Ethics committee country [1]
289644
0
New Zealand
Query!
Date submitted for ethics approval [1]
289644
0
06/05/2013
Query!
Approval date [1]
289644
0
21/05/2013
Query!
Ethics approval number [1]
289644
0
H13/011
Query!
Summary
Brief summary
Chronic low back pain is a significant burden to New Zealand, both in terms of health outcomes (disability) and economic impact (treatment costs, days off work).
We will investigate a specifically designed 8-week walking programme (Back2Activity programme) as a low cost, safe, and sustainable alternative to standard or usual physiotherapy care. The Back2Activity programme offers a potentially cost-effective option for reducing the disability and economic burden of this prevalent and costly condition and, potentially, other chronic non-communicable disease.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
41754
0
Prof G. David Baxter
Query!
Address
41754
0
School of Physiotherapy,
University of Otago,
325 Great King Street,
Dunedin 9016
Query!
Country
41754
0
New Zealand
Query!
Phone
41754
0
64 3 479 7411
Query!
Fax
41754
0
Query!
Email
41754
0
[email protected]
Query!
Contact person for public queries
Name
41755
0
Mr David S. Jackson
Query!
Address
41755
0
School of Physiotherapy,
University of Otago,
325 Great King Street,
Dunedin 9016
Query!
Country
41755
0
New Zealand
Query!
Phone
41755
0
64 3 479 8822
Query!
Fax
41755
0
Query!
Email
41755
0
[email protected]
Query!
Contact person for scientific queries
Name
41756
0
Prof G. David Baxter
Query!
Address
41756
0
School of Physiotherapy,
University of Otago,
325 Great King Street,
Dunedin 9016
Query!
Country
41756
0
New Zealand
Query!
Phone
41756
0
64 3 479 7411
Query!
Fax
41756
0
Query!
Email
41756
0
[email protected]
Query!
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.
Download to PDF