NCT01950091

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
606

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable low-back-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

Enrollment Period

6 months

First QC Date

September 11, 2013

Last Update Submit

October 21, 2013

Conditions

Keywords

low back paininternetapppreventiontreatment

Outcome Measures

Primary Outcomes (1)

  • Change in responses to the Modified Oswestry Low Back Pain Disability Questionnaire

    Back pain history: intensity, frequency, duration

    Baseline, 2 months, 4 months

Secondary Outcomes (1)

  • Change in responses to psycho-social measures (attitudes, knowledge, self efficacy, intentions); self treatment measures

    baseline, 2 and 4 months

Study Arms (3)

FitBack on-line intervention

EXPERIMENTAL

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

Behavioral: FitBack on-line intervention

Alternative website control

ACTIVE COMPARATOR

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

Other: Alternative Website Control

Usual care control group

NO INTERVENTION

No contact; Control group

Interventions

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

Also known as: Fitback app
FitBack on-line intervention

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

Alternative website control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Low Back PainAlzheimer Disease

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Blair Irvine, PhD

    ORCAS Research Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

September 11, 2013

First Posted

September 25, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 23, 2013

Record last verified: 2013-10