Veterans Walk to Beat Back Pain
| Tracking Information | |||||
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| First Received Date ICMJE | May 28, 2008 | ||||
| Last Updated Date | January 24, 2013 | ||||
| Start Date ICMJE | May 2009 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The Roland and Morris Disability Index (RMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00694018 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Veterans Walk to Beat Back Pain | ||||
| Official Title ICMJE | Veterans Walk to Beat Back Pain | ||||
| Brief Summary | The objective of this study is to assess whether an Internet-mediated pedometer based intervention will increase walking and improve function among individuals with chronic back pain. |
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| 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 is to assess the efficacy of an Internet-mediated pedometer based intervention that is designed to increase walking and improve pain-related function among individuals with chronic back pain. The Specific Aims of this randomized, controlled trial are: 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 propose to conduct 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 will be 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 will recruit patients with chronic back pain (primarily low back pain) receiving care at one VA health care system. Study patients will be randomized to one of two groups: 1) enhanced usual care or 2) the Internet-mediated, pedometer based intervention. All participants will attend an educational program designed specifically for individuals with chronic back pain. Study participants randomized to the intervention will be given an enhanced pedometer and have access to a study website that provides step goals and feedback, tailored motivational messages and an e-community. Those in the control group will receive a pedometer but not have access to the website. Both groups will be asked to complete on-line survey assessments at baseline, 6, and 12 months and to report adverse events on a regular basis. The primary outcome for this study is pain-related functional interference. Secondary outcomes include 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 will be conducted based on intention to treat principles and use multivariable modeling procedures to determine the effect of the intervention on our outcomes. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Back Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Krein 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 229 | ||||
| Completion Date | March 2012 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00694018 | ||||
| Other Study ID Numbers ICMJE | IIR 07-177 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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