Validation of the STarT Back Screening Tool in the Military

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 50 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03127826
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Brooke Army Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Daniel Rhon, DPT, DSc
Principal Investigator Affiliation	Director of Clinical Outcomes Research, Center for the Intrepid
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	U.S. Fed
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Low Back Pain, Lumbago, Radiculopathy, Intervertebral Disc Disorder

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brooke Army Medical Center, San Antonio, Texas

Status

Recruiting

Address

Brooke Army Medical Center

San Antonio, Texas, 78219

Site Contact

Rachel Mayhew, DPT

[email protected]

210-808-2575

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