Validation of the STarT Back Screening Tool in the Military

Brooke Army Medical Center

Status: Completed

Conditions: Radiculopathy; Intervertebral Disc Disorder; Lumbago; Low Back Pain

Treatments: Procedure: Risk Stratified Care; Procedure: Usual Care

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03127826

C.2016.047d

Details and patient eligibility

About

This is a trial to validate the use of the STarT Back Screening Tool (SBST) in the Military Health System for patients with low back pain presenting to primary care.

Full description

Subjects with low back pain presenting to primary care will be enrolled in a study that aims to evaluate the utility of the SBST for providing risk-stratified care. The concept of this approach revolves around matching treatment to patients based on their risk for developing chronic disability from back pain. Those at low risk receive less treatment, and those at high risk need more specialized treatment, that includes psychosocially-focused and cognitive considerations. This approach will be compared to usual care, where general practitioners carry out the course of action they think best for each patient, without any other guidance. Patients will be followed for 1 year.

Enrollment: 290 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females who are between the ages of 18-50 years old
2. Primary complaint of LBP for any duration, with or without associated radiculopathy
3. Can speak and understand English
4. Be willing and able to give full, informed written consent

Exclusion criteria

1. Red Flags: Any potentially serious or systemic disorders (e.g., cauda equina compression, inflammatory arthritis, compression fracture, malignancy, infection, severe neurological progression), serious illness or comorbidity
2. Spinal surgery in the past 24 months
3. Current pregnancy (or within the last 6 months)
4. Already receiving treatment (other than primary care) for this episode of LBP
5. Inability to attend regular treatment sessions
6. Pending litigation or a medical evaluation board

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

* "Managing Low Back Pain" pamphlet from DoD/VA * No specific guidance regarding physical therapy (PT) or other referrals, thus decision to refer or not will be made by the primary care manager (PCM) according to their preference

Treatment:

Procedure: Usual Care

Risk Stratified Care

Experimental group

Description:

* "Managing Low Back Pain" pamphlet from DoD/VA * Self-management education and tools * 2-item spinal manipulation screening/delivery if indicated Low Risk: * Home Exercise Program as indicated * No referral for ongoing physical therapy Medium Risk and High Risk * Referral to physical therapy for ongoing care at physical therapists discretion * Managed by a "psychologically informed physical therapy" trained physical therapist

Treatment:

Procedure: Risk Stratified Care