Validation of the STarT Back Screening Tool in the Military

Brooke Army Medical Center290 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

290

Conditions

Low Back Pain Lumbago Radiculopathy Intervertebral Disc Disorder

Interventions

Risk Stratified CarePROCEDURE

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 CarePROCEDURE

Usual care at the general practitioner's discretion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Brooke Army Medical Center

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Roland-Morris Disability Questionnaire (RMDQ)

The focus of the interventions is directed towards the secondary prevention of disabling back pain. The RMDQ will be used to assess physical disability. The RMDQ is a recommended disability measure that it is widely used in LBP studies in primary care and was the primary outcome used in the STarT Back trial by Hill et al. (2011). The form provides 24 statements and prompts the participant by stating "When your back hurts, you may find it difficult to do some of the things you normally do." Then it states, "Mark only the sentences that describe you today." Examples include "I avoid heavy jobs around the house because of my back" and "I find it difficult to turn over in bed because of my back". Scores are calculated by percent improvement from baseline to post-intervention \[(points of improvement made/total items checked at baseline) x 100\]

Time frame: 1 year

Secondary Outcomes

Patient Acceptable Symptom Scale (PASS)

Often defined as "the highest level of symptoms beyond which patients consider themselves well." This outcome measure has been used in previous studies looking at the effects of cervical thoracic thrust manipulation on shoulder pain. The question that will be asked to assess this level is, "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" Individuals who respond "yes" will be categorized as a success."

Time frame: 1 year

Credibility Expectancy Questionnaire (CEQ)

The CEQ is a 6-item self-report measure evaluating treatment credibility and expectations for improvement. This will be assessed at baseline after treatment group assignment is revealed to provide descriptive information about participants' perceptions of their treatment assignment and optimism for improvement. The CEQ may be used as a covariate if perceptions differ meaningfully between groups as participants' initial perceptions of treatment credibility can impact outcomes.

Time frame: 1 year

Data from ClinicalTrials.gov

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