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OpenTrials
Completed

NCT Number: NCT02284958

Walking Away From Back Pain, One Step at a Time

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0T3, Canada

About this study

Specific objectives of the study are:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard

Behavioral

Back care advice

Walking

Behavioral

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

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

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

    Quality of life

  9. 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

  10. Focus group data

    Time frame: Following 12 week intervention

    Walking group only, voluntary participation

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • University of Nottingham
  • University of Otago
  • University of Ulster

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2014
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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