MedPath

Walking Away From Back Pain, One Step at a Time

Not Applicable
Completed
Conditions
Low Back Pain
Interventions
Behavioral: Walking
Behavioral: Standard
Registration Number
NCT02284958
Lead Sponsor
University of Saskatchewan
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
174
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Walking groupWalkingEach 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.
Standard/Control groupStandardEach 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'.
Primary Outcome Measures
NameTimeMethod
Change in Oswestry Low Back Pain Disability Questionnaire scoreBaseline, 12 weeks, 6 months and 12 months
Secondary Outcome Measures
NameTimeMethod
Focus group dataFollowing 12 week intervention

Walking group only, voluntary participation

Change in mean number of steps per day for each week of the studyBaseline & 12 weeks
Change in six minute walk testBaseline, 12 weeks, 6 months & 12 months
Change in International Physical Activity Questionnaire scoreBaseline, 12 weeks, 6 months & 12 months
Change in Back Beliefs Questionnaire scoreBaseline, 12 weeks, 6 months & 12 months
Change in Exercise Self-efficacy Scale scoreBaseline, 12 weeks, 6 months & 12 months
Change in Global rating of change for physical activity scoreBaseline, 12 weeks, 6 months & 12 months
Change in health care usage and intervention costs over timeBaseline, 12 weeks, 6 months & 12 months

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

Change in Fear Avoidance Beliefs Questionnaire scoreBaseline, 12 weeks, 6 months & 12 months
Change in Euroqual-5D scoreBaseline, 12 weeks, 6 months & 12 months

Quality of life

Trial Locations

Locations (1)

University of Saskatchewan

🇨🇦

Saskatoon, Saskatchewan, Canada

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