We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01950091
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : October 23, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Low Back Pain Behavioral: FitBack on-line intervention Other: Alternative Website Control

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 606 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Internet App to Self-Manage Occasional Low Back Pain
Study Start Date : January 2013
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: FitBack on-line intervention
On-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence
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
Active Comparator: Alternative website control
Intervention is a Menu of links to 4 popular Websites offering back pain education
Other: Alternative Website Control
Intervention is a Menu of links to 4 popular Websites offering back pain education
No Intervention: Usual care control group
No contact; Control group


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950091


Sponsors and Collaborators
Oregon Center for Applied Science, Inc.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Blair Irvine, PhD ORCAS Research Scientist
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A. Blair Irvine, Research Scientist, Oregon Center for Applied Science, Inc.
ClinicalTrials.gov Identifier: NCT01950091     History of Changes
Other Study ID Numbers: Back Pain II Study
R44AR054652 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013

Keywords provided by A. Blair Irvine, Oregon Center for Applied Science, Inc.:
low back pain
internet
app
prevention
treatment

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms