Contact information
Type
Scientific
Primary contact
Prof Suzanne McDonough
ORCID ID
Contact details
Room 01F118
School of Health Sciences
University of Ulster
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
+44 (0)28 9036 6459
s.mcdonough@ulster.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A pedometer driven walking programme for chronic low back pain: a single centre, randomised, feasibility trial
Acronym
Study hypothesis
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
Office for Research Ethics Commitees Northern Ireland (ORECNI); application to be submitted on the 26th May 2009.
Study design
Single centre randomised feasibility trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/09/2009
Overall trial end date
01/09/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
n = 50
Participant 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
Recruitment start date
01/09/2009
Recruitment end date
01/09/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Room 01F118
Newtownabbey
BT37 0QB
United Kingdom
Sponsor information
Organisation
University of Ulster (UK)
Sponsor details
c/o Nick Curry
Research Office
University of Ulster
Shore Road
Newtownabbey
BT37 0QB
United Kingdom
+44 (0)28 9036 6629
n.curry@ulster.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Physiotherapy Research Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20633256
Publication citations
-
Results
McDonough SM, Tully MA, O'Connor SR, Boyd A, Kerr DP, O'Neill SM, Delitto A, Bradbury I, Tudor-Locke C, Baxter DG, Hurley DA, The back 2 activity trial: education and advice versus education and advice plus a structured walking programme for chronic low back pain., BMC Musculoskelet Disord, 2010, 11, 163, doi: 10.1186/1471-2474-11-163.