Walking Away From Back Pain, One Step at a Time

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Standard
* Behavioral: Walking


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard/Control group<br>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<br>* Back care advice<br>|
| Experimental: Walking group<br>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<br>* Back care advice, individualized 12 week pedometer-driven walking program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oswestry Low Back Pain Disability Questionnaire score |  | 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 |  | 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 | 
| 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 Euroqual-5D score | Quality of life | Baseline, 12 weeks, 6 months & 12 months | 
| Change in health care usage and intervention costs over time | Participant records health care usage and intervention costs over the 12 month study | Baseline, 12 weeks, 6 months & 12 months | 
| Focus group data | Walking group only, voluntary participation | Following 12 week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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walking, pedometer