Clinical trial NCT00694018: Veterans Walk to Beat Back Pain
Official title: Veterans Walk to Beat Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: randomized trial
walking
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-06-10
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The Roland Morris Disability Questionnaire (RDQ) Score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Sarah L. Krein, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.