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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator |
|
|
| Risk Stratified Care | Experimental |
Low Risk:
Medium Risk and High Risk
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Roland-Morris Disability Questionnaire (RMDQ) | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes Measurement Information System - Pain Interference | 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 | 1 year |
| EuroQoL (EQ-5D) |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Utilization - LBP Costs | Low back pain-related costs in the one year after enrollment | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Rhon, DPT, DSc | Director of Clinical Outcomes Research, Center for the Intrepid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | San Antonio | Texas | 78219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21963002 | Background | 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. | |
| 25098194 |
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Data sharing must go through a Data Sharing Agreement via the Defense Health Agency
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Usually the Data Sharing Agreement with the Defense Health Agency is good for 1 year. But the terms are all unique and contract-specific.
Through a proper Data Sharing Agreement Application with the United States Defense Health Agency
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care |
|
| FG001 | Risk Stratified Care |
Low Risk:
Medium Risk and High Risk
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care |
|
| BG001 | Risk Stratified Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Roland-Morris Disability Questionnaire (RMDQ) | 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 | The primary analysis included individuals with a baseline score AND at least 1 additional time point. This explains the discrepancy between the total that completed the study (N-290) and the number analyzed here (N=270). There were 11 in the usual care group and 9 in the risk-stratified care group that did not have additional scores other than baseline. | Posted | Least Squares Mean | 95% Confidence Interval | points on a scale | 1 year |
|
up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care |
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER visit for any reason | General disorders | Systematic Assessment | ER visits were determined from the EMR and claims data at the end of the year |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Rhon | Brooke Army Medical Center | 210-916-1599 | daniel.rhon2.ctr@health.cmil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2020 | Apr 22, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 7, 2021 | Apr 22, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D011843 | Radiculopathy |
| C535531 | Intervertebral disc disease |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Primary care providers will be unaware of risk stratification scores.
|
| Usual Care | Procedure | Usual care at the general practitioner's discretion |
|
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. |
| 1 year |
| Background |
| 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. |
| 22507360 | Background | 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. |
| 25858972 | Background | 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. |
| 27582134 | Background | 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. |
| 37410465 | Derived | Rhon DI, Greenlee TA, Poehlein E, Beneciuk JM, Green CL, Hando BR, Childs JD, George SZ. Effect of Risk-Stratified Care on Disability Among Adults With Low Back Pain Treated in the Military Health System: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2321929. doi: 10.1001/jamanetworkopen.2023.21929. |
Low Risk:
Medium Risk and High Risk
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Active Duty Service Member | Individuals on active duty in the military versus others (retired service members or dependents) | Count of Participants | Participants |
|
| OG001 | Risk Stratified Care |
Low Risk:
Medium Risk and High Risk
|
|
|
| Secondary | Patient Reported Outcomes Measurement Information System - Pain Interference | 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 | The primary analysis included individuals with a baseline score AND at least 1 additional time point. This explains the discrepancy between the total that completed the study (N-290) and the number analyzed here (N=270). There were 11 in the usual care group and 9 in the risk-stratified care group that did not have additional scores other than baseline. | Posted | Least Squares Mean | 95% Confidence Interval | T-Score | 1 year |
|
|
|
| Secondary | EuroQoL (EQ-5D) | 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. | The primary analysis included individuals with a baseline score AND at least 1 additional time point. This explains the discrepancy between the total that completed the study (N-290) and the number analyzed here (N=270). There were 11 in the usual care group and 9 in the risk-stratified care group that did not have additional scores other than baseline. | Posted | Least Squares Mean | 95% Confidence Interval | Utility Score on a scale from 0 to 1 | 1 year |
|
|
|
| Other Pre-specified | Healthcare Utilization - LBP Costs | Low back pain-related costs in the one year after enrollment | Posted | Mean | Standard Deviation | Dollars | 12 months |
|
|
|
| 0 |
| 145 |
| 0 |
| 145 |
| 59 |
| 145 |
| EG001 | Risk Stratified Care |
Low Risk:
Medium Risk and High Risk
| 0 | 145 | 0 | 145 | 73 | 145 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |