Walking Away From Back Pain, One Step at a Time

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284958
• Other study ID #: 14-218
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Standard
Back care advice
• Walking
Back care advice, individualized 12 week pedometer-driven walking program

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (4)

Lead Sponsor	Collaborator
University of Saskatchewan	University of Nottingham, University of Otago, University of Ulster

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oswestry Low Back Pain Disability Questionnaire score		Baseline, 12 weeks, 6 months and 12 months
Secondary	Change in mean number of steps per day for each week of the study		Baseline & 12 weeks
Secondary	Change in six minute walk test		Baseline, 12 weeks, 6 months & 12 months
Secondary	Change in International Physical Activity Questionnaire score		Baseline, 12 weeks, 6 months & 12 months
Secondary	Change in Fear Avoidance Beliefs Questionnaire score		Baseline, 12 weeks, 6 months & 12 months
Secondary	Change in Back Beliefs Questionnaire score		Baseline, 12 weeks, 6 months & 12 months
Secondary	Change in Exercise Self-efficacy Scale score		Baseline, 12 weeks, 6 months & 12 months
Secondary	Change in Global rating of change for physical activity score		Baseline, 12 weeks, 6 months & 12 months
Secondary	Change in Euroqual-5D score	Quality of life	Baseline, 12 weeks, 6 months & 12 months
Secondary	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
Secondary	Focus group data	Walking group only, voluntary participation	Following 12 week intervention