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Completed

NCT Number: NCT03127826

Validation of the STarT Back Screening Tool in the Military

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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Key information

Conditions

Low Back Pain Back Pain Intervertebral Disc Disorder Intervertebral disc disease Lumbago Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Spinal surgery in the past 24 months
  • Current pregnancy (or within the last 6 months)
  • Already receiving treatment (other than primary care) for this episode of LBP
  • Inability to attend regular treatment sessions
  • Pending litigation or a medical evaluation board

Treatment and study plan

Risk Stratified Care

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

usual care

Procedure

Usual care at the general practitioner's discretion

Primary outcomes

  1. Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: 1 year

    The RMDQ measures low back pain related disability by prompting the participant using 24 statements. The score ranges from 0 to 24 with higher scores indicating greater disability

Secondary outcomes

  1. Patient Reported Outcomes Measurement Information System - Pain Interference

    Time frame: 1 year

    The PROMIS Pain Interference domain provides a T-score based on the population mean of 50 (standard deviation of 10), with higher scores indicating higher pain interference

  2. EuroQoL (EQ-5D)

    Time frame: 1 year

    The EQ-5D is a generic quality of life questionnaire lhat assesses quality of life on a scale that can be referenced to other disease conditions. The EQ-5D covers 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The tool provides a quality of life scores, which is measured by a utility score with 1 representing perfect health and 0 representing a state considered as bad as being dead.

Other outcomes

  1. Healthcare Utilization - LBP Costs

    Time frame: 12 months

    Low back pain-related costs in the one year after enrollment

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study title

Validation of the STarT Back Screening Tool in the Primary Care Management of Low Back Pain in the Military Health System: A Randomized Trial of Risk-stratified vs. Usual Care

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 25, 2017
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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