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: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Back Pain
Other: Education and standard care
Behavioral: Internet mediated enhanced pedometer intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Veterans Walk to Beat Back Pain

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The Roland and Morris Disability Index (RMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 229
Study Start Date: May 2009
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Education and standard care
Educational program for individuals with chronic back pain.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694018

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: Sarah L. Krein, PhD RN VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00694018     History of Changes
Other Study ID Numbers: IIR 07-177
Study First Received: May 28, 2008
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
randomized trial
walking

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014