Clinical trial NCT03127826: Validation of the STarT Back Screening Tool in the Military
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lumbago
Radiculopathy
Intervertebral Disc Disorder
Keywords: Low Back Pain
Risk-Stratified Care
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2017-04-25
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: 1 year
Secondary outcomes:
measure: Patient Acceptable Symptom Scale (PASS)
timeFrame: 1 year
measure: Credibility Expectancy Questionnaire (CEQ)
timeFrame: 1 year
measure: Patient Reported Outcomes Measurement Information System 57-Item Profile v 2.0 (PROMIS-57)
timeFrame: 1 year
measure: EuroQoL (EQ-5D)
timeFrame: 1 year
measure: Healthcare Utilization
timeFrame: 2 years
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Director of Clinical Outcomes Research, Center for the Intrepid
name: Daniel Rhon, DPT, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28.
citation: Beneciuk JM, Fritz JM, George SZ. The STarT Back Screening Tool for prediction of 6-month clinical outcomes: relevance of change patterns in outpatient physical therapy settings. J Orthop Sports Phys Ther. 2014 Sep;44(9):656-64. doi: 10.2519/jospt.2014.5178. Epub 2014 Aug 6.
citation: Main CJ, Sowden G, Hill JC, Watson PJ, Hay EM. Integrating physical and psychological approaches to treatment in low back pain: the development and content of the STarT Back trial's 'high-risk' intervention (StarT Back; ISRCTN 37113406). Physiotherapy. 2012 Jun;98(2):110-6. doi: 10.1016/j.physio.2011.03.003. Epub 2011 Jun 12.
citation: Beneciuk JM, George SZ. Pragmatic Implementation of a Stratified Primary Care Model for Low Back Pain Management in Outpatient Physical Therapy Settings: Two-Phase, Sequential Preliminary Study. Phys Ther. 2015 Aug;95(8):1120-34. doi: 10.2522/ptj.20140418. Epub 2015 Apr 9.
citation: Saunders B, Bartlam B, Foster NE, Hill JC, Cooper V, Protheroe J. General Practitioners' and patients' perceptions towards stratified care: a theory informed investigation. BMC Fam Pract. 2016 Aug 31;17(1):125. doi: 10.1186/s12875-016-0511-2.