Walking Away From Back Pain, One Step at a Time

NCT ID: NCT02284958

Last Updated: 2018-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-11-30

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:

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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard/Control group

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'.

Group Type ACTIVE_COMPARATOR

Standard

Intervention Type BEHAVIORAL

Back care advice

Walking group

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.

Group Type EXPERIMENTAL

Walking

Intervention Type BEHAVIORAL

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

Interventions

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Standard

Back care advice

Intervention Type BEHAVIORAL

Walking

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

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulster

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role collaborator

University of Otago

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Stephan Milosavljevic

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephan Milosavljevic, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 33607979 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25885913 (View on PubMed)

Other Identifiers

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14-218

Identifier Type: -

Identifier Source: org_study_id

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