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
Scientific
Room 01F118
School of Health Sciences
University of Ulster
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
| Phone | +44 (0)28 9036 6459 |
|---|---|
| s.mcdonough@ulster.ac.uk |
Study information
| Study design | Single centre randomised feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/09/2009 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | n = 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
- Northern Ireland
- United Kingdom
Study participating centre
Room 01F118
Newtownabbey
BT37 0QB
United Kingdom
BT37 0QB
United Kingdom
Sponsor information
University of Ulster (UK)
University/education
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 |
|---|---|
| n.curry@ulster.ac.uk | |
| Website | http://www.ulster.ac.uk/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
