Low Back PainNCT02284958
Walking Away From Back Pain, One Step at a Time
A study testing Standard and Walking in people with Low Back Pain, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Standard and Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Standard, Walking
- Keywords
- walking, pedometer
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandardBehavioural
Back care advice
WalkingBehavioural
Back care advice, individualized 12 week pedometer-driven walking program
| Study group | Role | What they receive |
|---|---|---|
| Standard/Control group | Active comparator | 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'. Receives: Behavioral: Standard |
| Walking group | Experimental | 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. Receives: Behavioral: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oswestry Low Back Pain Disability Questionnaire score
Measured: Baseline, 12 weeks, 6 months and 12 months
Secondary outcomes (10)
Change in mean number of steps per day for each week of the study
Measured: Baseline & 12 weeks
Change in six minute walk test
Measured: Baseline, 12 weeks, 6 months & 12 months
Change in International Physical Activity Questionnaire score
Measured: Baseline, 12 weeks, 6 months & 12 months
Change in Fear Avoidance Beliefs Questionnaire score
Measured: Baseline, 12 weeks, 6 months & 12 months
Change in Back Beliefs Questionnaire score
Measured: Baseline, 12 weeks, 6 months & 12 months
Change in Exercise Self-efficacy Scale score
Measured: Baseline, 12 weeks, 6 months & 12 months
Change in Global rating of change for physical activity score
Measured: Baseline, 12 weeks, 6 months & 12 months
Change in Euroqual-5D score
Quality of life
Measured: Baseline, 12 weeks, 6 months & 12 months
Change in health care usage and intervention costs over time
Participant records health care usage and intervention costs over the 12 month study
Measured: Baseline, 12 weeks, 6 months & 12 months
Focus group data
Walking group only, voluntary participation
Measured: Following 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startApr 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster, University of Nottingham, University of Otago
- Responsible party
- Principal investigator, Stephan Milosavljevic, University of Saskatchewan
- Investigators
- Stephan Milosavljevic, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284958
- Sponsor's protocol ID
- 14-218
- Status last verified
- Nov 2018
- First submitted
- 23 Oct 2014
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33607979Milosavljevic 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.
PubMed 25885913
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02284958
- Acronym / sponsor ID
- 14-218
- Conditions
- Low Back Pain
- Keywords
- walking, pedometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- University of Ulster, University of Nottingham, University of Otago
- Study start
- Apr 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard/Control group | Active comparator | Behavioral: StandardEach 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'. |
| Walking group | Experimental | Behavioral: WalkingEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- any cardiorespiratory or other medical condition limiting exercise tolerance;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StandardBack care advice | Behavioural | Standard/Control group |
| WalkingBack care advice, individualized 12 week pedometer-driven walking program | Behavioural | Walking group |
Primary outcome
Change in Oswestry Low Back Pain Disability Questionnaire score
Time frame: Baseline, 12 weeks, 6 months and 12 months
10 secondary outcomes
Change in mean number of steps per day for each week of the study
Time frame: Baseline & 12 weeks
Change in six minute walk test
Time frame: Baseline, 12 weeks, 6 months & 12 months
Change in International Physical Activity Questionnaire score
Time frame: Baseline, 12 weeks, 6 months & 12 months
Change in Fear Avoidance Beliefs Questionnaire score
Time frame: Baseline, 12 weeks, 6 months & 12 months
Change in Back Beliefs Questionnaire score
Time frame: Baseline, 12 weeks, 6 months & 12 months
Change in Exercise Self-efficacy Scale score
Time frame: Baseline, 12 weeks, 6 months & 12 months
Change in Global rating of change for physical activity score
Time frame: Baseline, 12 weeks, 6 months & 12 months
Change in Euroqual-5D score
Time frame: Baseline, 12 weeks, 6 months & 12 months
Change in health care usage and intervention costs over time
Time frame: Baseline, 12 weeks, 6 months & 12 months
Focus group data
Time frame: Following 12 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Derived from this study: PubMed 33607979Lang 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.
- Derived from this study: PubMed 25885913Milosavljevic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Milosavljevic, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard and Walking in people with Low Back Pain, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Low Back Pain Disability Questionnaire score (time frame: Baseline, 12 weeks, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02284958, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.