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Veterans Walk to Beat Back Pain

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education and standard care
Internet mediated enhanced pedometer intervention
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Back Pain focused on measuring randomized trial, walking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Education and Standard Care

Internet Mediated Enhanced Pedometer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The Roland Morris Disability Questionnaire (RDQ) Score
The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability

Secondary Outcome Measures

Full Information

First Posted
May 28, 2008
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00694018
Brief Title
Veterans Walk to Beat Back Pain
Official Title
Veterans Walk to Beat Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
randomized trial, walking

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education and Standard Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Internet Mediated Enhanced Pedometer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Education and standard care
Intervention Description
Educational program for individuals with chronic back pain.
Intervention Type
Behavioral
Intervention Name(s)
Internet mediated enhanced pedometer intervention
Intervention Description
Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community.
Primary Outcome Measure Information:
Title
The Roland Morris Disability Questionnaire (RDQ) Score
Description
The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah L. Krein, PhD RN
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23969029
Citation
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.
Results Reference
result
PubMed Identifier
20836856
Citation
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. doi: 10.1186/1471-2474-11-205.
Results Reference
result
PubMed Identifier
26934620
Citation
Krein 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.
Results Reference
derived

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Veterans Walk to Beat Back Pain

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