Internet App to Self-Manage Occasional Low Back Pain

Low Back Pain Clinical Trial

— BackPain2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950091
• Other study ID #: Back Pain II Study
• Secondary ID: R44AR054652
• Status: Completed
• Phase: N/A
• First received: September 11, 2013
• Last updated: October 21, 2013
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: Oregon Center for Applied Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Other:
• Alternative Website Control
Intervention is a Menu of links to 4 popular Websites offering back pain education

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Center for Applied Science, Inc.	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in responses to the Modified Oswestry Low Back Pain Disability Questionnaire	Back pain history: intensity, frequency, duration	Baseline, 2 months, 4 months	No
Secondary	Change in responses to psycho-social measures (attitudes, knowledge, self efficacy, intentions); self treatment measures	Internally developed rating scales	baseline, 2 and 4 months	No