NCT02284958

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

2.6 years

First QC Date

October 23, 2014

Last Update Submit

November 4, 2018

Conditions

Low Back Pain

Keywords

walkingpedometer

Outcome Measures

Primary Outcomes (1)

  • Change in Oswestry Low Back Pain Disability Questionnaire score

    Baseline, 12 weeks, 6 months and 12 months

Secondary Outcomes (10)

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

    Baseline & 12 weeks

  • Change in six minute walk test

    Baseline, 12 weeks, 6 months & 12 months

  • Change in International Physical Activity Questionnaire score

    Baseline, 12 weeks, 6 months & 12 months

  • Change in Fear Avoidance Beliefs Questionnaire score

    Baseline, 12 weeks, 6 months & 12 months

  • Change in Back Beliefs Questionnaire score

    Baseline, 12 weeks, 6 months & 12 months

  • +5 more secondary outcomes

Study Arms (2)

Standard/Control group

ACTIVE COMPARATOR

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

Walking group

EXPERIMENTAL

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

StandardBEHAVIORAL

Back care advice

Standard/Control group
WalkingBEHAVIORAL

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

Walking group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0T3, Canada

Location

Related Publications (2)

  • 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.

    PMID: 33607979DERIVED

  • 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.

    PMID: 25885913DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Walking

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Stephan Milosavljevic, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2014

First Posted

November 6, 2014

Study Start

April 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 6, 2018

Record last verified: 2018-11

Locations

CA(1)