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Validation of the STarT Back Screening Tool in the Military

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03127826
Recruitment Status : Active, not recruiting
First Posted : April 25, 2017
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Dan Rhon, Brooke Army Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Lumbago Radiculopathy Intervertebral Disc Disorder Procedure: Risk Stratified Care Procedure: Usual Care Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: Primary care providers will be unaware of risk stratification scores.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 7, 2017
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: 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
Procedure: Usual Care
Usual care at the general practitioner's discretion

Experimental: 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
Procedure: 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





Primary Outcome Measures :
  1. Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: 1 year ]
    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]


Secondary Outcome Measures :
  1. Patient Acceptable Symptom Scale (PASS) [ Time Frame: 1 year ]
    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."

  2. Credibility Expectancy Questionnaire (CEQ) [ Time Frame: 1 year ]
    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.

  3. Patient Reported Outcomes Measurement Information System 57-Item Profile v 2.0 (PROMIS-57) [ Time Frame: 1 year ]
    The PROMIS 57 efficiently assesses several outcomes important to patients including pain intensity and interference, sleep disturbance, anxiety, depression, fatigue, and social role participation using items developed with rigorous methodology and patient input. This is a 57-item questionnaire with 8 questions per domain.

  4. EuroQoL (EQ-5D) [ Time Frame: 1 year ]
    The EQ-5D is a generic quality of life questionnaire that will assess 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. Each domain has 3 response categories: level 1, "no problems"; level 2, "some problems"; and level 3, "inability or extreme problems." Responses are combined to give a 5-digit descriptive health state classification (e.g., 11222). The EQ-5D yields a total of 243 possible health states. Valuations for each health state are available. The EQ-5D is commonly used in economic evaluation of interventions and cost-effectiveness analysis.

  5. Healthcare Utilization [ Time Frame: 2 years ]
    Low back pain related healthcare costs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127826


Locations
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United States, Texas
Brooke Army Medical Center
San Antonio, Texas, United States, 78219
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
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Principal Investigator: Daniel Rhon, DPT, DSc Director of Clinical Outcomes Research, Center for the Intrepid
Publications:
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Responsible Party: Dan Rhon, Director of Clinical Outcomes Research at the Center for the Intrepid, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT03127826    
Other Study ID Numbers: C.2016.047d
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing must go through a Data Sharing Agreement via the Defense Health Agency
Time Frame: Usually the Data Sharing Agreement with the Defense Health Agency is good for 1 year. But the terms are all unique and contract-specific.
Access Criteria: Through a proper Data Sharing Agreement Application (DSAA) with the US Defense Health Agency
URL: https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Submit-a-Data-Sharing-Application

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dan Rhon, Brooke Army Medical Center:
Low Back Pain
Risk-Stratified Care
Additional relevant MeSH terms:
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Radiculopathy
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases