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
Secondary identifying numbers N/A
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

Study designSingle centre randomised feasibility trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA pedometer driven walking programme for chronic low back pain: a single centre, randomised, feasibility trial
Study objectivesStudy 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) studiedChronic low back pain
InterventionWalking 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 typeOther
Primary outcome measureOswestry 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.
Secondary outcome measures1. 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.
Overall study start date01/09/2009
Completion date01/09/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsn = 50
Key inclusion criteriaAdults (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 criteria1. 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 enrolment01/09/2009
Date of final enrolment01/09/2010

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Room 01F118
Newtownabbey
BT37 0QB
United Kingdom

Sponsor information

University of Ulster (UK)
University/education

c/o Nick Curry
Research Office
University of Ulster
Shore Road
Newtownabbey
BT37 0QB
Northern Ireland
United Kingdom

Phone +44 (0)28 9036 6629
Email n.curry@ulster.ac.uk
Website http://www.ulster.ac.uk/
ROR logo "ROR" https://ror.org/01yp9g959

Funders

Funder type

Research organisation

Physiotherapy Research Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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