Back PainNCT00694018
Veterans Walk to Beat Back Pain
A study testing Internet mediated enhanced pedometer intervention in people with Back Pain, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The objective of this study was to assess whether an Internet-mediated pedometer based intervention would increase walking and improve function among individuals with chronic back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- Internet mediated enhanced pedometer intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Veterans receiving care at the VA Ann Arbor Healthcare System
- Have back pain that has persisted for more than 3 months
- Have a sedentary lifestyle (less than 150 minutes of physical activity per week)
- Have access to a computer (with Windows XP or Vista) on at least a weekly basis with an available USB port and Internet access
- Have a working e-mail address
- Are competent to provide written informed consent
Show all 9Show fewer
- Are able to communicate in English
- Are not institutionalized
- Can identify a health care provider who can provide medical clearance.
Who cannot join
- Currently pregnant
- Cannot walk at least one block
- Cannot obtain written clearance to start a walking program from a treating healthcare provider
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
The objective of this study was to assess whether an Internet-mediated pedometer based intervention would increase walking and improve function among individuals with chronic back pain.
Read the detailed description
Project Background/Rationale: Chronic pain, and especially back pain, is common among VA patients, affecting approximately 60% of veterans using VA primary care services. Chronic pain is associated with increased disability, poorer health status, anxiety and depression, decreased quality of life, decreased employment and increased health services use and costs. Current evidence suggests that exercise is one of the most effective strategies for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low cost approach to help patients with chronic back pain initiate and maintain an exercise program.
Project Objectives: The primary objective of this study was to assess the efficacy of an Internet-mediated pedometer based intervention that was designed to increase walking and improve pain-related function among individuals with chronic back pain. The Specific Aims of this randomized, controlled trial were: 1) To determine whether an internet-mediated pedometer based intervention will reduce pain-related functional interference among patients with chronic back pain in the short term and over a 12-month timeframe; 2) To assess the effect of the intervention on walking (measured by step counts), quality of life, pain intensity, pain related fear and self-efficacy for exercise among patients with chronic back pain; and 3) To identify factors associated with a sustained increase in walking over a 12-month timeframe among patients randomized to the intervention.
Project Methods: We conducted a randomized controlled trial of an Internet-mediated, pedometer based intervention to promote walking and improve pain-related function among patients with chronic back pain compared to enhanced usual care. Participants were followed for 12 months to investigate the efficacy of the intervention in assisting patients with initiating and maintaining a regular walking program and improving pain-related function. We recruited patients with chronic back pain (primarily low back pain) receiving care at one VA health care system. Study patients were randomized to one of two groups: 1) enhanced usual care or 2) the Internet-mediated, pedometer based intervention. All participants attended an educational program designed specifically for individuals with chronic back pain. Study participants randomized to the intervention were given an enhanced pedometer and access to a study website that provided step goals and feedback, tailored motivational messages and an e-community. Those in the control group received a pedometer but did not have access to the website. Both groups completed on-line survey assessments at baseline, 6, and 12 months and were asked to report adverse events on a regular basis. The primary outcome for this study was pain-related functional interference. Secondary outcomes included average daily steps at 12 months as measured using the study pedometer, health related quality of life, pain intensity, pain related fear and self-efficacy for exercise. The analysis was conducted based on intention to treat principles and used multivariable modeling procedures to determine the effect of the intervention on our outcomes.
- Conditions
- Back Pain
- Being tested
- Education and standard care, Internet mediated enhanced pedometer intervention
- Keywords
- randomized trial, walking
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and standard careOther
Educational program for individuals with chronic back pain.
Internet mediated enhanced pedometer interventionBehavioural
Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community.
| Study group | Role | What they receive |
|---|---|---|
| Education and Standard Care | Active comparator | Received standard care and participated in an educational program for individuals with chronic back pain. Also received an uploading pedometer but no feedback or goals about their walking activity. Receives: Other: Education and standard care |
| Internet Mediated Enhanced Pedometer | Experimental | In addition to standard care and participating in an educational program, participants received an enhanced pedometer for uploading step information, e-mail messages with weekly step goals and access to a website that provided step goals and feedback, tailored motivational messages and on on-line community for communication asynchronously with staff and other participants. Receives: Other: Education and standard care; Behavioral: Internet mediated enhanced pedometer intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Roland Morris Disability Questionnaire (RDQ) Score
The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startMay 2009
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sarah L. Krein, PhD RN, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694018
- Sponsor's protocol ID
- IIR 07-177
- Status last verified
- Sep 2014
- First submitted
- 28 May 2008
- Last updated
- 27 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Krein SL, Kadri R, Hughes M, Kerr EA, Piette JD, Holleman R, Kim HM, Richardson CR. Pedometer-based internet-mediated intervention for adults with chronic low back pain: randomized controlled trial. J Med Internet Res. 2013 Aug 19;15(8):e181. doi: 10.2196/jmir.2605.
PubMed 23969029Krein SL, Metreger T, Kadri R, Hughes M, Kerr EA, Piette JD, Kim HM, Richardson CR. Veterans walk to beat back pain: study rationale, design and protocol of a randomized trial of a pedometer-based internet mediated intervention for patients with chronic low back pain. BMC Musculoskelet Disord. 2010 Sep 13;11:205. doi: 10.1186/1471-2474-11-205.
PubMed 20836856Krein SL, Bohnert A, Kim HM, Harris ME, Richardson CR. Opioid use and walking among patients with chronic low back pain. J Rehabil Res Dev. 2016;53(1):107-16. doi: 10.1682/JRRD.2014.08.0190.
PubMed 26934620
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veterans Walk to Beat Back Pain
- ClinicalTrials.gov ID
- NCT00694018
- Acronym / sponsor ID
- IIR 07-177
- Conditions
- Back Pain
- Keywords
- randomized trial, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Jun 2008 (estimated)
- Results
- Posted 17 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to assess whether an Internet-mediated pedometer based intervention would increase walking and improve function among individuals with chronic back pain.
Detailed description
Project Background/Rationale: Chronic pain, and especially back pain, is common among VA patients, affecting approximately 60% of veterans using VA primary care services. Chronic pain is associated with increased disability, poorer health status, anxiety and depression, decreased quality of life, decreased employment and increased health services use and costs. Current evidence suggests that exercise is one of the most effective strategies for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low cost approach to help patients with chronic back pain initiate and maintain an exercise program.
Project Objectives: The primary objective of this study was to assess the efficacy of an Internet-mediated pedometer based intervention that was designed to increase walking and improve pain-related function among individuals with chronic back pain. The Specific Aims of this randomized, controlled trial were: 1) To determine whether an internet-mediated pedometer based intervention will reduce pain-related functional interference among patients with chronic back pain in the short term and over a 12-month timeframe; 2) To assess the effect of the intervention on walking (measured by step counts), quality of life, pain intensity, pain related fear and self-efficacy for exercise among patients with chronic back pain; and 3) To identify factors associated with a sustained increase in walking over a 12-month timeframe among patients randomized to the intervention.
Project Methods: We conducted a randomized controlled trial of an Internet-mediated, pedometer based intervention to promote walking and improve pain-related function among patients with chronic back pain compared to enhanced usual care. Participants were followed for 12 months to investigate the efficacy of the intervention in assisting patients with initiating and maintaining a regular walking program and improving pain-related function. We recruited patients with chronic back pain (primarily low back pain) receiving care at one VA health care system. Study patients were randomized to one of two groups: 1) enhanced usual care or 2) the Internet-mediated, pedometer based intervention. All participants attended an educational program designed specifically for individuals with chronic back pain. Study participants randomized to the intervention were given an enhanced pedometer and access to a study website that provided step goals and feedback, tailored motivational messages and an e-community. Those in the control group received a pedometer but did not have access to the website. Both groups completed on-line survey assessments at baseline, 6, and 12 months and were asked to report adverse events on a regular basis. The primary outcome for this study was pain-related functional interference. Secondary outcomes included average daily steps at 12 months as measured using the study pedometer, health related quality of life, pain intensity, pain related fear and self-efficacy for exercise. The analysis was conducted based on intention to treat principles and used multivariable modeling procedures to determine the effect of the intervention on our outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education and Standard Care | Active comparator | Other: Education and standard careReceived standard care and participated in an educational program for individuals with chronic back pain. Also received an uploading pedometer but no feedback or goals about their walking activity. |
| Internet Mediated Enhanced Pedometer | Experimental | Other: Education and standard care, Behavioral: Internet mediated enhanced pedometer interventionIn addition to standard care and participating in an educational program, participants received an enhanced pedometer for uploading step information, e-mail messages with weekly step goals and access to a website that provided step goals and feedback, tailored motivational messages and on on-line community for communication asynchronously with staff and other participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Veterans receiving care at the VA Ann Arbor Healthcare System
- Have back pain that has persisted for more than 3 months
- Have a sedentary lifestyle (less than 150 minutes of physical activity per week)
- Have access to a computer (with Windows XP or Vista) on at least a weekly basis with an available USB port and Internet access
- Have a working e-mail address
Key exclusion criteria (3 listed)
- Currently pregnant
- Cannot walk at least one block
- Cannot obtain written clearance to start a walking program from a treating healthcare provider
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 |
|---|---|---|
| Education and standard careEducational program for individuals with chronic back pain. | Other | Education and Standard Care, Internet Mediated Enhanced Pedometer |
| Internet mediated enhanced pedometer interventionEnhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community. | Behavioural | Internet Mediated Enhanced Pedometer |
Primary outcome
The Roland Morris Disability Questionnaire (RDQ) Score
Time frame: 12 months
The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23969029Krein SL, Kadri R, Hughes M, Kerr EA, Piette JD, Holleman R, Kim HM, Richardson CR. Pedometer-based internet-mediated intervention for adults with chronic low back pain: randomized controlled trial. J Med Internet Res. 2013 Aug 19;15(8):e181. doi: 10.2196/jmir.2605.
- Results publication: PubMed 20836856Krein SL, Metreger T, Kadri R, Hughes M, Kerr EA, Piette JD, Kim HM, Richardson CR. Veterans walk to beat back pain: study rationale, design and protocol of a randomized trial of a pedometer-based internet mediated intervention for patients with chronic low back pain. BMC Musculoskelet Disord. 2010 Sep 13;11:205. doi: 10.1186/1471-2474-11-205.
- Derived from this study: PubMed 26934620Krein SL, Bohnert A, Kim HM, Harris ME, Richardson CR. Opioid use and walking among patients with chronic low back pain. J Rehabil Res Dev. 2016;53(1):107-16. doi: 10.1682/JRRD.2014.08.0190.
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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.
Sarah L. Krein, PhD RN principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet mediated enhanced pedometer intervention in people with Back Pain, run by US Department of Veterans Affairs at 1 site in United States.
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 9 inclusion and 3 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 27 Apr 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Roland Morris Disability Questionnaire (RDQ) Score (time frame: 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 NCT00694018, which also lists 3 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 27 Apr 2015.