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Internet App to Self-Manage Occasional Low Back Pain (BackPain2)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FitBack on-line intervention
Alternative Website Control
Sponsored by
Oregon Center for Applied Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Back Pain focused on measuring low back pain, internet, app, prevention, treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • suffered low back pain in previous 3 months
  • employed or family of employee

Exclusion Criteria:

  • on-going medical care for low back pain
  • positive response to questions about symptoms which medically disqualify potential participant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    FitBack on-line intervention

    Alternative website control

    Usual care control group

    Arm Description

    On-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence

    Intervention is a Menu of links to 4 popular Websites offering back pain education

    No contact; Control group

    Outcomes

    Primary Outcome Measures

    Change in responses to the Modified Oswestry Low Back Pain Disability Questionnaire
    Back pain history: intensity, frequency, duration

    Secondary Outcome Measures

    Change in responses to psycho-social measures (attitudes, knowledge, self efficacy, intentions); self treatment measures
    Internally developed rating scales

    Full Information

    First Posted
    September 11, 2013
    Last Updated
    October 21, 2013
    Sponsor
    Oregon Center for Applied Science, Inc.
    Collaborators
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01950091
    Brief Title
    Internet App to Self-Manage Occasional Low Back Pain
    Acronym
    BackPain2
    Official Title
    Randomized Controlled Trial of Internet App to Self-Manage Occasional Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oregon Center for Applied Science, Inc.
    Collaborators
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Nonspecific low back pain (NLBP) is the diagnosis for 85% of low back pain sufferers with no underlying medical cause (e.g., herniated disc, spinal stenosis) that requires physician care. Treatment, however, is impractical for many physicians to implement during office visits, and there are relatively few providers for NLBP treatment that follow national pain control guidelines. This study evaluated the efficacy of an on-line intervention using desktop computers or mobile technology to help users self treat NLBP occurrences and to engage in activities to decrease future occurences.
    Detailed Description
    Methods. A total of 606 adults, 18 years of age and older were recruited, screened, and consented online. They were assessed on-line at baseline, at two months weeks, and at four months After the baseline assessments, participants were randomized into NLBP treatment (TX), alternative website control (AWC), and no-contact control groups. The TX and AWC groups received 8 weekly emails prompt to visit their respective experimental websites. Add Details here.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    low back pain, internet, app, prevention, treatment

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    FitBack on-line intervention
    Arm Type
    Experimental
    Arm Description
    On-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence
    Arm Title
    Alternative website control
    Arm Type
    Active Comparator
    Arm Description
    Intervention is a Menu of links to 4 popular Websites offering back pain education
    Arm Title
    Usual care control group
    Arm Type
    No Intervention
    Arm Description
    No contact; Control group
    Intervention Type
    Behavioral
    Intervention Name(s)
    FitBack on-line intervention
    Other Intervention Name(s)
    Fitback app
    Intervention Description
    On-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence
    Intervention Type
    Other
    Intervention Name(s)
    Alternative Website Control
    Intervention Description
    Intervention is a Menu of links to 4 popular Websites offering back pain education
    Primary Outcome Measure Information:
    Title
    Change in responses to the Modified Oswestry Low Back Pain Disability Questionnaire
    Description
    Back pain history: intensity, frequency, duration
    Time Frame
    Baseline, 2 months, 4 months
    Secondary Outcome Measure Information:
    Title
    Change in responses to psycho-social measures (attitudes, knowledge, self efficacy, intentions); self treatment measures
    Description
    Internally developed rating scales
    Time Frame
    baseline, 2 and 4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: suffered low back pain in previous 3 months employed or family of employee Exclusion Criteria: on-going medical care for low back pain positive response to questions about symptoms which medically disqualify potential participant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Blair Irvine, PhD
    Organizational Affiliation
    ORCAS Research Scientist
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25565416
    Citation
    Irvine AB, Russell H, Manocchia M, Mino DE, Cox Glassen T, Morgan R, Gau JM, Birney AJ, Ary DV. Mobile-Web app to self-manage low back pain: randomized controlled trial. J Med Internet Res. 2015 Jan 2;17(1):e1. doi: 10.2196/jmir.3130.
    Results Reference
    derived

    Learn more about this trial

    Internet App to Self-Manage Occasional Low Back Pain

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