CClinicalTrials.gg
Sign In
CompletedNCT02284958Updated Nov 6, 2018

Walking Away From Back Pain, One Step at a Time

An interventional study of Standard and Walking in Low Back Pain, sponsored by University of Saskatchewan. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-06.

Sponsored by University of Saskatchewan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will investigate if a 12-week, individually-tailored walking program, using pedometers will be a more clinically and cost-effective option for the management of chronic low back pain than standardized advice and education.

Read the detailed description

Specific objectives of the study are:

  1. To determine perceived levels of disability and baseline levels of walking activity in a sample of those with chronic low back pain (CLBP)
  2. To determine the uptake and adherence to a pedometer-driven walking program for people with CLBP
  3. To test the clinical and cost-effectiveness of a walking programme to improve outcomes for CLBP compared to a standardized back care education package
  4. To test the feasibility of a walking programme in a sub-sample of rural Saskatchewan farmers/agricultural workers.
02

Conditions studied

  • Low Back Pain

Keywords

  • walking
  • pedometer
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 174 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • males and females aged 18 years or over,
  • experiencing low back pain (i.e. between the 12th costal margin and gluteal fold with or without associated leg pain) persisting for a minimum of three months, and
  • assessed as capable of participating in a walking programme.

Exclusion criteria

Exclusion Criteria:

  • any spinal surgery in the past 12 months;
  • evidence of nerve root, spinal cord, or cauda equina compression;
  • severe spinal stenosis indicated by signs of neurogenic claudication, grade 3 to 4 spondylolisthesis, fibromyalgia, or systemic/inflammatory disorder;
  • as well as any other current lower extremity musculoskeletal injury or contraindication to increasing physical activity (PA) levels.

The latter may include:

  • any cardiorespiratory or other medical condition limiting exercise tolerance;
  • history of serious psychological or psychiatric illness (mild depression eligible for inclusion); and/or
  • pregnancy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
174 participants (actual)

Study arms

  • Active comparator
    Standard/Control group

    Each participant will receive a one-off individualized educational session regarding the management of chronic low back pain with a Physical Therapist: includes a physical examination, standardized advice \& provision of the 'Back Book'.

    Behavioral: Standard

  • Experimental
    Walking group

    Each participant will receive a one-off educational session as per standard/control group followed by a 12 week graded, individually tailored, pedometer driven walking programme given by a Physical Therapist. Participants will be monitored each week and provided with encouragement and advice to increase the number of steps taken each day.

    Behavioral: Walking

Interventions

  • BehavioralStandard

    Back care advice

  • BehavioralWalking

    Back care advice, individualized 12 week pedometer-driven walking program

06

What researchers measure

Primary outcomes

  1. Change in Oswestry Low Back Pain Disability Questionnaire score

    Time frame: Baseline, 12 weeks, 6 months and 12 months

Secondary outcomes

  1. Change in mean number of steps per day for each week of the study

    Time frame: Baseline & 12 weeks

  2. Change in six minute walk test

    Time frame: Baseline, 12 weeks, 6 months & 12 months

  3. Change in International Physical Activity Questionnaire score

    Time frame: Baseline, 12 weeks, 6 months & 12 months

  4. Change in Fear Avoidance Beliefs Questionnaire score

    Time frame: Baseline, 12 weeks, 6 months & 12 months

  5. Change in Back Beliefs Questionnaire score

    Time frame: Baseline, 12 weeks, 6 months & 12 months

  6. Change in Exercise Self-efficacy Scale score

    Time frame: Baseline, 12 weeks, 6 months & 12 months

  7. Change in Global rating of change for physical activity score

    Time frame: Baseline, 12 weeks, 6 months & 12 months

  8. Change in Euroqual-5D score

    Quality of life

    Time frame: Baseline, 12 weeks, 6 months & 12 months

  9. Change in health care usage and intervention costs over time

    Participant records health care usage and intervention costs over the 12 month study

    Time frame: Baseline, 12 weeks, 6 months & 12 months

  10. Focus group data

    Walking group only, voluntary participation

    Time frame: Following 12 week intervention

07

Study locations

1 site
  • University of Saskatchewan
    Saskatoon, Saskatchewan S7N 0T3, Canada
08

References and documents

Publications

  • Lang AE, Hendrick PA, Clay L, Mondal P, Trask CM, Bath B, Penz ED, Stewart SA, Baxter GD, Hurley DA, McDonough SM, Milosavljevic S. A randomized controlled trial investigating effects of an individualized pedometer driven walking program on chronic low back pain. BMC Musculoskelet Disord. 2021 Feb 19;22(1):206. doi: 10.1186/s12891-021-04060-8. PubMed 33607979 ↗
  • Milosavljevic S, Clay L, Bath B, Trask C, Penz E, Stewart S, Hendrick P, Baxter GD, Hurley DA, McDonough SM. Walking away from back pain: one step at a time - a community-based randomised controlled trial. BMC Public Health. 2015 Feb 13;15:144. doi: 10.1186/s12889-015-1496-9. PubMed 25885913 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02284958
Lead sponsor
University of Saskatchewan
Collaborators
University of Ulster, University of Nottingham, University of Otago
Responsible party
Stephan Milosavljevic (Principal Investigator, University of Saskatchewan) — Principal investigator
First posted
Nov 6, 2014
Start date
Apr 2015
Primary completion
Nov 2017
Completion
Nov 2017
Last update
Nov 6, 2018

Study contacts

Stephan Milosavljevic, PhD
principal investigator · University of Saskatchewan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Back Pain→

Other studies from this sponsor

University of Saskatchewan

Start the discussion