Walking Away From Back Pain, One Step at a Time

November 4, 2018 updated by: Stephan Milosavljevic, University of Saskatchewan

A Single-centre, Randomized Controlled Trial Investigating Clinical Utility and Cost-effectiveness of an Individualized Pedometer Driven Walking Programme for People With Chronic Low Back Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0T3
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Back care advice
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
Back care advice, individualized 12 week pedometer-driven walking program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Oswestry Low Back Pain Disability Questionnaire score
Time Frame: Baseline, 12 weeks, 6 months and 12 months
Baseline, 12 weeks, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean number of steps per day for each week of the study
Time Frame: Baseline & 12 weeks
Baseline & 12 weeks
Change in six minute walk test
Time Frame: Baseline, 12 weeks, 6 months & 12 months
Baseline, 12 weeks, 6 months & 12 months
Change in International Physical Activity Questionnaire score
Time Frame: Baseline, 12 weeks, 6 months & 12 months
Baseline, 12 weeks, 6 months & 12 months
Change in Fear Avoidance Beliefs Questionnaire score
Time Frame: Baseline, 12 weeks, 6 months & 12 months
Baseline, 12 weeks, 6 months & 12 months
Change in Back Beliefs Questionnaire score
Time Frame: Baseline, 12 weeks, 6 months & 12 months
Baseline, 12 weeks, 6 months & 12 months
Change in Exercise Self-efficacy Scale score
Time Frame: Baseline, 12 weeks, 6 months & 12 months
Baseline, 12 weeks, 6 months & 12 months
Change in Global rating of change for physical activity score
Time Frame: Baseline, 12 weeks, 6 months & 12 months
Baseline, 12 weeks, 6 months & 12 months
Change in Euroqual-5D score
Time Frame: Baseline, 12 weeks, 6 months & 12 months
Quality of life
Baseline, 12 weeks, 6 months & 12 months
Change in health care usage and intervention costs over time
Time Frame: Baseline, 12 weeks, 6 months & 12 months
Participant records health care usage and intervention costs over the 12 month study
Baseline, 12 weeks, 6 months & 12 months
Focus group data
Time Frame: Following 12 week intervention
Walking group only, voluntary participation
Following 12 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

University of Nottingham
University of Otago
University of Ulster

Investigators

  • Principal Investigator: Stephan Milosavljevic, PhD, University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 4, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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