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

October 21, 2013 updated by: A. Blair Irvine, Oregon Center for Applied Science, Inc.

Randomized Controlled Trial of Internet App to Self-Manage Occasional Low Back Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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Study Type

Interventional

Enrollment (Actual)

606

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 2 months, 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 2 and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Center for Applied Science, Inc.

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Blair Irvine, PhD, ORCAS Research Scientist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 20, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Estimate)

October 23, 2013

Last Update Submitted That Met QC Criteria

October 21, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Back Pain II Study
  • R44AR054652 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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