Validation of the STarT Back Screening Tool in the Military

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-07

Study Completion Date

2021-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Low Back Pain Lumbago Radiculopathy Intervertebral Disc Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Primary care providers will be unaware of risk stratification scores.

Study Groups

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Usual Care

* "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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type PROCEDURE

Usual care at the general practitioner's discretion

Risk Stratified Care

* "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

Group Type EXPERIMENTAL

Risk Stratified Care

Intervention Type PROCEDURE

Physical therapists providing care will all have attended live training in PIPT principles and be involved in monthly continuing education on these principles. The use of specific principles is guided by the patient's risk stratification (as determined by the STarT Back Tool).

Medium Risk:

\- Reassurance will be provided to address specific concerns related to their LBP and implications on work

High Risk:

\- Physical therapy will be psychologically augmented with the assessment of biopsychosocial risk factors and the adoption of cognitive behavioral principles that explore patient concerns and address unhelpful beliefs and behaviors, including tailored education (e.g., stress management and pain neuroscience), graded exercise, \& graded exposure

Interventions

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Risk Stratified Care

Physical therapists providing care will all have attended live training in PIPT principles and be involved in monthly continuing education on these principles. The use of specific principles is guided by the patient's risk stratification (as determined by the STarT Back Tool).

Medium Risk:

\- Reassurance will be provided to address specific concerns related to their LBP and implications on work

High Risk:

\- Physical therapy will be psychologically augmented with the assessment of biopsychosocial risk factors and the adoption of cognitive behavioral principles that explore patient concerns and address unhelpful beliefs and behaviors, including tailored education (e.g., stress management and pain neuroscience), graded exercise, \& graded exposure

Intervention Type PROCEDURE

Usual Care

Usual care at the general practitioner's discretion

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No