Condition category
Musculoskeletal Diseases
Date applied
02/03/2009
Date assigned
17/06/2009
Last edited
09/02/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ulster.ac.uk/

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20633256

Publication citations

  1. 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.

Additional files

Editorial Notes