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Trial record 75 of 685 for:    applied AND web-

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

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ClinicalTrials.gov Identifier: NCT01950091
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : October 23, 2013
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
A. Blair Irvine, Oregon Center for Applied Science, Inc.

Tracking Information
First Submitted Date  ICMJE September 11, 2013
First Posted Date  ICMJE September 25, 2013
Last Update Posted Date October 23, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2013)
Change in responses to the Modified Oswestry Low Back Pain Disability Questionnaire [ Time Frame: Baseline, 2 months, 4 months ]
Back pain history: intensity, frequency, duration
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01950091 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2013)
Change in responses to psycho-social measures (attitudes, knowledge, self efficacy, intentions); self treatment measures [ Time Frame: baseline, 2 and 4 months ]
Internally developed rating scales
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet App to Self-Manage Occasional Low Back Pain
Official Title  ICMJE Randomized Controlled Trial of Internet App to Self-Manage Occasional Low Back Pain
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Behavioral: FitBack on-line intervention
    On-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence
    Other Name: Fitback app
  • Other: Alternative Website Control
    Intervention is a Menu of links to 4 popular Websites offering back pain education
Study Arms  ICMJE
  • Experimental: FitBack on-line intervention
    On-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence
    Intervention: Behavioral: FitBack on-line intervention
  • Active Comparator: Alternative website control
    Intervention is a Menu of links to 4 popular Websites offering back pain education
    Intervention: Other: Alternative Website Control
  • No Intervention: Usual care control group
    No contact; Control group
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2013)
606
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01950091
Other Study ID Numbers  ICMJE Back Pain II Study
R44AR054652 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party A. Blair Irvine, Oregon Center for Applied Science, Inc.
Study Sponsor  ICMJE Oregon Center for Applied Science, Inc.
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Blair Irvine, PhD ORCAS Research Scientist
PRS Account Oregon Center for Applied Science, Inc.
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP