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Walking Away From Back Pain, One Step at a Time

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Standard

Walking

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring walking, pedometer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard/Control group

Walking group

Arm Description

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'.

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.

Outcomes

Primary Outcome Measures

Change in Oswestry Low Back Pain Disability Questionnaire score

Secondary Outcome Measures

Change in mean number of steps per day for each week of the study

Change in six minute walk test

Change in International Physical Activity Questionnaire score

Change in Fear Avoidance Beliefs Questionnaire score

Change in Back Beliefs Questionnaire score

Change in Exercise Self-efficacy Scale score

Change in Global rating of change for physical activity score

Change in Euroqual-5D score

Quality of life

Change in health care usage and intervention costs over time

Participant records health care usage and intervention costs over the 12 month study

Focus group data

Walking group only, voluntary participation

Full Information

NCT ID

NCT02284958

First Posted

October 23, 2014

Last Updated

November 4, 2018

Sponsor

University of Saskatchewan

Collaborators

University of Ulster, University of Nottingham, University of Otago

1. Study Identification

Unique Protocol Identification Number

NCT02284958

Brief Title

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

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Saskatchewan

Collaborators

University of Ulster, University of Nottingham, University of Otago

4. Oversight

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

walking, pedometer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard/Control group

Arm Type

Active Comparator

Arm Description

Arm Title

Walking group

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Standard

Intervention Description

Back care advice

Intervention Type

Behavioral

Intervention Name(s)

Walking

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Oswestry Low Back Pain Disability Questionnaire score

Time Frame

Baseline, 12 weeks, 6 months and 12 months

Secondary Outcome Measure Information:

Title

Change in mean number of steps per day for each week of the study

Time Frame

Baseline & 12 weeks

Title

Change in six minute walk test

Time Frame