MOBile Instruction for Low Back Pain (MOBIL)

Brooke Army Medical Center

Status: Completed

Conditions: Low Back Pain

Treatments: Behavioral: Educational Video App

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02777983

C.2015.029

Details and patient eligibility

About

The purpose of this project is to measure the impact of a short educational session on outcomes for patients consulting in primary care for low back pain. Subjects will be patients consulting to their primary care provider for a primary complaint and new episode of low back pain. Subjects will be randomized to receiving the educational tool versus usual care (information only without an educational component) in the clinic immediately prior to seeing their PCP. Patients will be followed for a 6-month period, and outcome measures will be collected and compared across both groups.

Full description

Patients that arrive for an initial evaluation for low back pain will be randomized to either receive the video education via an application (app) on a tablet computer, or usual care (which consists of information in the form of a handout but no further education prior to seeing the Primary Care Provider - PCP). To control for exposure to the tablet computer, subjects in both groups will use the tablet computer to fill out the self-reported outcome measures.

This will all take place while the patient is waiting to see their PCP, who will be blinded to the educational intervention that the patient received. After enrollment and completion of baseline outcome measures and surveys, the subject will be randomized to one of the 2 arms, receive the intervention, and then proceed to have their appointment with their PCP. The appointment with the PCP will proceed per usual care standards, with no additional research interventions. The subjects will be contacted for a follow-up at 1 and 6 months for assessment of self-reported outcomes measuring pain, function, and disability. The investigators will also abstract healthcare utilization from claims data and compare variables of healthcare use between both groups over the 6-month period following enrollment (radiographs, MRIs, prescription opioids, and specialty referrals).

Enrollment: 220 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A Tricare beneficiary with a primary complaint of low back pain consulting in a primary care clinic
2. Between the age of 18 - 50 years
3. Read and speak English well enough to interact with the mobile education technology, provide informed consent and follow study instructions

Exclusion criteria

1. History of prior surgery to the lumbosacral spine
2. Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease
3. Known current pregnancy or history of pregnancy in the last 6 months
4. Already seen in primary care for an episode of low back pain within the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

Education Group

Experimental group

Description:

This will consist of a 6-minute educational video app created and delivered within an application (mobile app) that will be interactive in nature, asking multiple-choice questions at the end to help reinforce key points of the video message. It will include self-management guidance based on evidence related to activity, exercise, and other behavioral components known to influence the prognosis of low back pain. Subjects will also receive the 1-page general conditioning handout that the usual care group will receive.

Treatment:

Behavioral: Educational Video App

Usual Care Group

No Intervention group

Description:

Subjects randomized to usual care will receive a 1-page generic informational handout on general conditioning recommended for low back pain, in addition to whatever education the subject's PCP decides to provide.