The Step Back Up trial: the feasibility of a pedometer driven walking programme for chronic low back pain

ISRCTN	ISRCTN67030896
DOI	https://doi.org/10.1186/ISRCTN67030896
Protocol serial number	N/A
Sponsor	University of Ulster (UK)
Funder	Physiotherapy Research Foundation (UK)

Submission date: 02/03/2009
Registration date: 17/06/2009
Last edited: 09/02/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Suzanne McDonough
Scientific

Room 01F118
School of Health Sciences
University of Ulster
Shore Road
Newtownabbey
BT37 0QB
United Kingdom

Phone	+44 (0)28 9036 6459
Email	s.mcdonough@ulster.ac.uk

Study information

Primary study design	Interventional
Study design	Single centre randomised feasibility trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pedometer driven walking programme for chronic low back pain: a single centre, randomised, feasibility trial
Study objectives	Study aim: To test the feasibility of using a pedometer-driven, individually tailored, walking programme as an adjunct to a single education session for patients with chronic low back pain. Specific objectives of the study are: 1. To assess recruitment rate and adherence to a walking group or education only group 2. To compare changes in outcome between groups 3. To determine the incidence of musculo-skeletal and other related injuries between groups 4. To carry out a qualitative exploration of participants' experience of the interventions
Ethics approval(s)	Office for Research Ethics Commitees Northern Ireland (ORECNI); application to be submitted on the 26th May 2009.
Health condition(s) or problem(s) studied	Chronic low back pain
Intervention	Walking Group: Graded, individually tailored, pedometer (Yamax Digiwalker SW-200, Yamax, Japan) driven walking programme given by a physiotherapist. This will be based on baseline assessment of PA using an accelerometer (PAL Technologies, Glasgow, UK). The physiotherapist will recommend an additional 25% of any shortfall in activity (25% of recommended 10,000-baseline), per week, for three weeks. Education Only Group: Single session with a physiotherapist including a physical examination and standardised advice using the Back Book.
Intervention type	Other
Primary outcome measure(s)	Oswestry Disability Questionnaire (ODQ). All outcome measures will be assessed at baseline, at eight weeks (on completion of trial) and at six months. All follow up outcomes shall be assessed by a researcher blinded to group allocation.
Key secondary outcome measure(s)	1. Objective measurement of PA level (assessed by accelerometry) 2. International Physical Activity Questionnaire [IPAQ] - short form 3. Fear-Avoidance Beliefs Questionnaire (FABQ) 4. General Perceived Self-Efficacy Scale (GPSES) 5. Health outcomes (changes in body mass index [BMI kg/m^2], waist:hip ratio and resting blood pressures) 6. Stage of change questionnaire 7. Patient Preference 8. Participant Satisfaction Questionnaire All outcome measures will be assessed at baseline, at eight weeks (on completion of trial) and at six months. All follow up outcomes shall be assessed by a researcher blinded to group allocation.
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	Adults (aged 18 - 65 years, either sex) with a diagnosis of chronic low back pain (defined as pain and discomfort localised below the costal margin and above the inferior gluteal folds, with or without referred leg pain, persisting for more than 12 weeks)
Key exclusion criteria	1. Any potential participant with a high level of physical activity (assessed by the International Physical Activity Questionnaire [IPAQ]) at initial screening 2. Any potential participant taking more than an average of 8,500 steps per day (recorded by an accelerometer) over 7 days prior to randomisation
Date of first enrolment	01/09/2009
Date of final enrolment	01/09/2010

Locations

Countries of recruitment

United Kingdom
Northern Ireland

Study participating centre

Room 01F118

Newtownabbey
BT37 0QB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/07/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes