Clinical trial NCT02284958: Walking Away From Back Pain, One Step at a Time
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: walking
pedometer
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: University of Ulster
name: University of Nottingham
name: University of Otago
First posted: 2014-11-06
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Oswestry Low Back Pain Disability Questionnaire score
timeFrame: Baseline, 12 weeks, 6 months and 12 months
Secondary outcomes:
measure: Change in mean number of steps per day for each week of the study
timeFrame: Baseline & 12 weeks
measure: Change in six minute walk test
timeFrame: Baseline, 12 weeks, 6 months & 12 months
measure: Change in International Physical Activity Questionnaire score
timeFrame: Baseline, 12 weeks, 6 months & 12 months
measure: Change in Fear Avoidance Beliefs Questionnaire score
timeFrame: Baseline, 12 weeks, 6 months & 12 months
measure: Change in Back Beliefs Questionnaire score
timeFrame: Baseline, 12 weeks, 6 months & 12 months
measure: Change in Exercise Self-efficacy Scale score
timeFrame: Baseline, 12 weeks, 6 months & 12 months
measure: Change in Global rating of change for physical activity score
timeFrame: Baseline, 12 weeks, 6 months & 12 months
measure: Change in Euroqual-5D score
timeFrame: Baseline, 12 weeks, 6 months & 12 months
measure: Change in health care usage and intervention costs over time
timeFrame: Baseline, 12 weeks, 6 months & 12 months
measure: Focus group data
timeFrame: Following 12 week intervention
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Stephan Milosavljevic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lang AE, Hendrick PA, Clay L, Mondal P, Trask CM, Bath B, Penz ED, Stewart SA, Baxter GD, Hurley DA, McDonough SM, Milosavljevic S. A randomized controlled trial investigating effects of an individualized pedometer driven walking program on chronic low back pain. BMC Musculoskelet Disord. 2021 Feb 19;22(1):206. doi: 10.1186/s12891-021-04060-8.
citation: Milosavljevic S, Clay L, Bath B, Trask C, Penz E, Stewart S, Hendrick P, Baxter GD, Hurley DA, McDonough SM. Walking away from back pain: one step at a time - a community-based randomised controlled trial. BMC Public Health. 2015 Feb 13;15:144. doi: 10.1186/s12889-015-1496-9.