Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
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
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.
Secondary ID [1] 282908 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 289720 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290047 290047 0 0
Physiotherapy
Musculoskeletal 290058 290058 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287604 0
Rehabilitation
Intervention code [2] 287612 0
Treatment: Other
Intervention code [3] 287613 0
Lifestyle
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).
Control group
Active

Outcomes
Primary outcome [1] 290099 0
The Oswestry Disability Questionnaire (ODQ)
Timepoint [1] 290099 0
8 weeks/ 6 months/ 12 months
Secondary outcome [1] 303938 0
International Physical Activity Questionnaire (IPAQ; short form)
Timepoint [1] 303938 0
8 weeks/ 6 months/ 12 months
Secondary outcome [2] 303939 0
Fear-Avoidance Beliefs Questionnaire (FABQ)
Timepoint [2] 303939 0
8 weeks/ 6 months/ 12 months
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.
Timepoint [3] 303940 0
8 weeks/ 6 months/ 12 months
Secondary outcome [4] 303941 0
Back Beliefs questionnaire (BBQ)
Timepoint [4] 303941 0
8 weeks/ 6 months/ 12 months
Secondary outcome [5] 303942 0
Physical Activity Self-efficacy Scale
Timepoint [5] 303942 0
8 weeks/ 6 months/ 12 months
Secondary outcome [6] 303943 0
Global Rating of Change for physical activity (GROC)
Timepoint [6] 303943 0
8 weeks/ 6 months/ 12 months
Secondary outcome [7] 303944 0
Pain (Visual Analogue Scale)
Timepoint [7] 303944 0
8 weeks/ 6 months/ 12 months

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/06/2013
Actual
23/07/2013
Date of last participant enrolment
Anticipated
Actual
28/02/2014
Date of last data collection
Anticipated
Actual
18/05/2015
Sample size
Target
55
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 5246 0
New Zealand
State/province [1] 5246 0
Otago

Funding & Sponsors
Funding source category [1] 287685 0
University
Name [1] 287685 0
University of Otago
Country [1] 287685 0
New Zealand
Primary sponsor type
Individual
Name
Professor G. David Baxter
Address
School of Physiotherapy
University of Otago
325 Great King Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 286417 0
None
Name [1] 286417 0
Address [1] 286417 0
Country [1] 286417 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289644 0
University of Otago Human Ethics Committee
Ethics committee address [1] 289644 0
University of Otago
PO Box 56
Dunedin 9054
Ethics committee country [1] 289644 0
New Zealand
Date submitted for ethics approval [1] 289644 0
06/05/2013
Approval date [1] 289644 0
21/05/2013
Ethics approval number [1] 289644 0
H13/011

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41754 0
Prof G. David Baxter
Address 41754 0
School of Physiotherapy,
University of Otago,
325 Great King Street,
Dunedin 9016
Country 41754 0
New Zealand
Phone 41754 0
64 3 479 7411
Fax 41754 0
Email 41754 0
[email protected]
Contact person for public queries
Name 41755 0
David S. Jackson
Address 41755 0
School of Physiotherapy,
University of Otago,
325 Great King Street,
Dunedin 9016
Country 41755 0
New Zealand
Phone 41755 0
64 3 479 8822
Fax 41755 0
Email 41755 0
[email protected]
Contact person for scientific queries
Name 41756 0
G. David Baxter
Address 41756 0
School of Physiotherapy,
University of Otago,
325 Great King Street,
Dunedin 9016
Country 41756 0
New Zealand
Phone 41756 0
64 3 479 7411
Fax 41756 0
Email 41756 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.