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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education and Standard Care | Active Comparator | 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. |
|
| Internet Mediated Enhanced Pedometer | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education and standard care | Other | Educational program for individuals with chronic back pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Roland Morris Disability Questionnaire (RDQ) Score | The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah L. Krein, PhD RN | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23969029 | Result | 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. | |
| 20836856 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Education and Standard Care | Education and standard care: Educational program for individuals with chronic back pain. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Education and Standard Care | Education and standard care: Educational program for individuals with chronic back pain. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
During the 1 year intervention period
Participants reported any health problems whether or not study related as prompted by weekly (intervention) or monthly (control) emails. After the first four weeks and then every eight weeks after that, all participants were prompted to complete a survey on the website that asked about specific adverse events and symptoms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Education and Standard Care | Education and standard care: Educational program for individuals with chronic back pain. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All serious adverse events | General disorders | Systematic Assessment | serious adverse events during the study period ranged from hospitalizations for planned surgeries to death. All were reviewed and none were found to be study-related. They were reported but not categorized by system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All (non-serious) adverse events | General disorders | Systematic Assessment | We have overall events/person/group but only number of events by system/group. The most common events: worsening back pain (74 education, 85 pedometer), musculoskeletal (36 education, 76 pedometer) and cardiovascular (37 education, 48 pedometer) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah L. Krein, PhD, RN | VA Ann Arbor Center for Clinical Management Research | 734-845-3621 | sarah.krein@va.gov |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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| Internet mediated enhanced pedometer intervention | Behavioral | Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community. |
|
| 26934620 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Roland Morris Disability Questionnaire (RDQ) Score | The Roland Morris Disability Questionnaire score ranges from 0-24, with higher scores indicating greater disability. | Mean | Standard Deviation | units on a scale |
|
| Daily step counts | Mean | Standard Deviation | steps |
|
|
|
| 26 |
| 118 |
| 76 |
| 118 |
| EG001 | 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. | 27 | 111 | 87 | 111 |
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| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |