Veterans Walk to Beat Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00694018
First received: May 28, 2008
Last updated: January 24, 2013
Last verified: May 2012

May 28, 2008
January 24, 2013
May 2009
January 2012   (final data collection date for primary outcome measure)
The Roland and Morris Disability Index (RMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00694018 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Veterans Walk to Beat Back Pain
Veterans Walk to Beat Back Pain

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Back Pain
  • Other: Education and standard care
    Educational program for individuals with chronic back pain.
  • Behavioral: Internet mediated enhanced pedometer intervention
    Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community.
  • Active Comparator: Arm 1
    Veterans receiving care at the VA Ann Arbor Healthcare System who have back pain that has persisted for more than 3 months; Have a sedentary lifestyle; Have access to a computer on at least a weekly basis with an available USB port and Internet access; Have a working e-mail address and who receive medical clearance from a treating health care provider.
    Intervention: Other: Education and standard care
  • Experimental: Arm 2
    Veterans receiving care at the VA Ann Arbor Healthcare System who have back pain that has persisted for more than 3 months; Have a sedentary lifestyle; Have access to a computer on at least a weekly basis with an available USB port and Internet access; Have a working e-mail address and who receive medical clearance from a treating health care provider.
    Interventions:
    • Other: Education and standard care
    • Behavioral: Internet mediated enhanced pedometer intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
229
March 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Are able to communicate in English
  • Are not institutionalized
  • Can identify a health care provider who can provide medical clearance.

Exclusion Criteria:

  • Currently pregnant
  • Cannot walk at least one block
  • Cannot obtain written clearance to start a walking program from a treating healthcare provider
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00694018
IIR 07-177
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Sarah L. Krein, PhD RN VA Ann Arbor Healthcare System
Department of Veterans Affairs
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP