Low Back PainBackPain2NCT01950091
Internet App to Self-Manage Occasional Low Back Pain
A study testing FitBack on-line intervention in people with Low Back Pain, run by Oregon Center for Applied Science, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- FitBack on-line intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- suffered low back pain in previous 3 months
- employed or family of employee
Who cannot join
- on-going medical care for low back pain
- positive response to questions about symptoms which medically disqualify potential participant
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- FitBack on-line intervention, Alternative Website Control
- Keywords
- low back pain, internet, app, prevention, treatment
- Medical subject headings
- Low Back Pain, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitBack on-line interventionBehavioural
Also called Fitback app
On-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence
Alternative Website ControlOther
Intervention is a Menu of links to 4 popular Websites offering back pain education
| Study group | Role | What they receive |
|---|---|---|
| FitBack on-line intervention | Experimental | On-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence Receives: Behavioral: FitBack on-line intervention |
| Alternative website control | Active comparator | Intervention is a Menu of links to 4 popular Websites offering back pain education Receives: Other: Alternative Website Control |
| Usual care control group | No intervention | No contact; Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in responses to the Modified Oswestry Low Back Pain Disability Questionnaire
Back pain history: intensity, frequency, duration
Measured: Baseline, 2 months, 4 months
Secondary outcomes (1)
Change in responses to psycho-social measures (attitudes, knowledge, self efficacy, intentions); self treatment measures
Internally developed rating scales
Measured: baseline, 2 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Center for Applied Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, A. Blair Irvine, Oregon Center for Applied Science, Inc.
- Investigators
- Blair Irvine, PhD, Principal investigator, ORCAS Research Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950091
- Sponsor's protocol ID
- Back Pain II Study
- Other IDs
- R44AR054652
- Acronym
- BackPain2
- Status last verified
- Oct 2013
- First submitted
- 11 Sep 2013
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25565416
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Internet App to Self-Manage Occasional Low Back Pain
- ClinicalTrials.gov ID
- NCT01950091
- Acronym / sponsor ID
- BackPain2 / Back Pain II Study
- Conditions
- Low Back Pain
- Keywords
- low back pain, internet, app, prevention, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Oregon Center for Applied Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FitBack on-line intervention | Experimental | Behavioral: FitBack on-line interventionOn-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence |
| Alternative website control | Active comparator | Other: Alternative Website ControlIntervention is a Menu of links to 4 popular Websites offering back pain education |
| Usual care control group | No intervention | –No contact; Control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suffered low back pain in previous 3 months
- employed or family of employee
Key exclusion criteria (2 listed)
- on-going medical care for low back pain
- positive response to questions about symptoms which medically disqualify potential participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitBack on-line interventionAlso: Fitback appOn-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence | Behavioural | FitBack on-line intervention |
| Alternative Website ControlIntervention is a Menu of links to 4 popular Websites offering back pain education | Other | Alternative website control |
Primary outcome
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
1 secondary outcome
Change in responses to psycho-social measures (attitudes, knowledge, self efficacy, intentions); self treatment measures
Time frame: baseline, 2 and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
- Derived from this study: PubMed 25565416Irvine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blair Irvine, PhD principal investigator
ORCAS Research Scientist
Questions about this trial
What is this clinical trial studying?
A study testing FitBack on-line intervention in people with Low Back Pain, run by Oregon Center for Applied Science, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in responses to the Modified Oswestry Low Back Pain Disability Questionnaire (time frame: Baseline, 2 months, 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01950091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2013.