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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- University of Saskatchewan
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- Change in Oswestry Low Back Pain Disability Questionnaire score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Stephan Milosavljevic
Principal Investigator
University of Saskatchewan
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in Oswestry Low Back Pain Disability Questionnaire score
Time Frame: Baseline, 12 weeks, 6 months and 12 months
Secondary Outcomes
- Focus group data(Following 12 week intervention)
- 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 Back Beliefs Questionnaire score(Baseline, 12 weeks, 6 months & 12 months)
- Change in Exercise Self-efficacy Scale score(Baseline, 12 weeks, 6 months & 12 months)
- Change in Global rating of change for physical activity score(Baseline, 12 weeks, 6 months & 12 months)
- Change in health care usage and intervention costs over time(Baseline, 12 weeks, 6 months & 12 months)
- Change in Fear Avoidance Beliefs Questionnaire score(Baseline, 12 weeks, 6 months & 12 months)
- Change in Euroqual-5D score(Baseline, 12 weeks, 6 months & 12 months)