Back Pain
Conditions
Keywords
randomized trial, walking
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.
Interventions
OTHEREducation and standard care
Educational program for individuals with chronic back pain.
BEHAVIORALInternet 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.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Roland Morris Disability Questionnaire (RDQ) Score | 12 months | The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Education and Standard Care Education and standard care: Educational program for individuals with chronic back pain. | 118 |
| Internet Mediated Enhanced Pedometer Education and standard care: Educational program for individuals with chronic back pain.
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. | 111 |
| Total | 229 |
Baseline characteristics
| Characteristic | Education and Standard Care | Internet Mediated Enhanced Pedometer | Total |
|---|---|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 12.8 | 51.2 years STANDARD_DEVIATION 12.5 | 51.5 years STANDARD_DEVIATION 12.6 |
| Daily step counts | 4321.9 steps STANDARD_DEVIATION 2285.4 | 4492.9 steps STANDARD_DEVIATION 2749.9 | 4404.8 steps STANDARD_DEVIATION 2517 |
| Race/Ethnicity, Customized Black | 11 participants | 14 participants | 25 participants |
| Race/Ethnicity, Customized Other or prefer not to answer | 6 participants | 15 participants | 21 participants |
| Race/Ethnicity, Customized White | 101 participants | 82 participants | 183 participants |
| Region of Enrollment United States | 118 participants | 111 participants | 229 participants |
| Roland Morris Disability Questionnaire (RDQ) Score | 9.8 units on a scale STANDARD_DEVIATION 5.7 | 9.1 units on a scale STANDARD_DEVIATION 6 | 9.5 units on a scale STANDARD_DEVIATION 5.8 |
| Sex: Female, Male Female | 16 Participants | 12 Participants | 28 Participants |
| Sex: Female, Male Male | 102 Participants | 99 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 76 / 118 | 87 / 111 |
| serious Total, serious adverse events | 26 / 118 | 27 / 111 |
Outcome results
Primary
The Roland Morris Disability Questionnaire (RDQ) Score
The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability
Time frame: 12 months
Population: The number of participants analyzed is slightly lower than the number who completed the study at 12 months due to item non-response on the final study survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education and Standard Care | The Roland Morris Disability Questionnaire (RDQ) Score | 8.3 units on a scale | Standard Deviation 5.6 |
| Internet Mediated Enhanced Pedometer | The Roland Morris Disability Questionnaire (RDQ) Score | 6.6 units on a scale | Standard Deviation 5.9 |