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Walking Away From Back Pain, One Step at a Time

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02284958
Enrollment
174
Registered
2014-11-06
Start date
2015-04-30
Completion date
2017-11-30
Last updated
2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

walking, pedometer

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.

Interventions

BEHAVIORALStandard

Back care advice

BEHAVIORALWalking

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

Sponsors

University of Ulster
CollaboratorOTHER
University of Nottingham
CollaboratorOTHER
University of Otago
CollaboratorOTHER
University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in Oswestry Low Back Pain Disability Questionnaire scoreBaseline, 12 weeks, 6 months and 12 months

Secondary

MeasureTime frameDescription
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 Fear Avoidance 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 Euroqual-5D scoreBaseline, 12 weeks, 6 months & 12 monthsQuality of life
Change in health care usage and intervention costs over timeBaseline, 12 weeks, 6 months & 12 monthsParticipant records health care usage and intervention costs over the 12 month study
Focus group dataFollowing 12 week interventionWalking group only, voluntary participation
Change in Back Beliefs Questionnaire scoreBaseline, 12 weeks, 6 months & 12 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026