Veterans Walk to Beat Back Pain
|ClinicalTrials.gov Identifier: NCT00694018|
Recruitment Status : Completed
First Posted : June 10, 2008
Results First Posted : October 17, 2014
Last Update Posted : April 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Back Pain||Other: Education and standard care Behavioral: Internet mediated enhanced pedometer intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||229 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Veterans Walk to Beat Back Pain|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||March 2012|
Active Comparator: Education and Standard Care
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.
Other: Education and standard care
Educational program for individuals with chronic back pain.
Experimental: Internet Mediated Enhanced Pedometer
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.
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694018
|United States, Michigan|
|VA Ann Arbor Healthcare System, Ann Arbor, MI|
|Ann Arbor, Michigan, United States, 48105|
|Principal Investigator:||Sarah L. Krein, PhD RN||VA Ann Arbor Healthcare System, Ann Arbor, MI|