Low Back PainNCT03127826

Validation of the STarT Back Screening Tool in the Military

A study testing Risk Stratified Care in people with Low Back Pain and Lumbago, run by Brooke Army Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Low Back Pain, Lumbago, Radiculopathy
What is being tested?: Risk Stratified Care
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 290 participants
Where: 1 siteUnited States
Study dates: 7 Apr 2017to 1 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Males and females who are between the ages of 18-50 years old
Primary complaint of LBP for any duration, with or without associated radiculopathy
Can speak and understand English
Be willing and able to give full, informed written consent

Who cannot join

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
Spinal surgery in the past 24 months
Current pregnancy (or within the last 6 months)
Already receiving treatment (other than primary care) for this episode of LBP
Inability to attend regular treatment sessions
Pending litigation or a medical evaluation board

Trial locations and contacts

1 site in 1 country.

United States1 site

Brooke Army Medical Center
San Antonio, Texas, 78219

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Low Back Pain, Lumbago, Radiculopathy, Intervertebral Disc Disorder
Being tested: Risk Stratified Care, Usual Care
Keywords: Low Back Pain, Risk-Stratified Care
Medical subject headings: Low Back Pain, Radiculopathy, Intervertebral disc disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Risk Stratified CareProcedure or surgery
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 or surgery
Usual care at the general practitioner's discretion

Study groups in NCT03127826
Study group	Role	What they receive
Usual Care	Active comparator	* "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 Receives: Procedure: Usual Care
Risk Stratified Care	Experimental	* "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 Receives: Procedure: Risk Stratified Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 1 year

Secondary outcomes (2)

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
Measured: 1 year
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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Apr 20171 Jul 2021

First posted25 Apr 2017
Study start7 Apr 2017
Primary completion26 Feb 2021
Study completion1 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03127826
Sponsor's protocol ID: C.2016.047d
Status last verified: May 2026
First submitted: 14 Apr 2017
Last updated: 24 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data sharing must go through a Data Sharing Agreement via the Defense Health Agency

Publications

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.
PubMed 21963002
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.
PubMed 25098194
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.
PubMed 22507360
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.
PubMed 25858972
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.
PubMed 27582134
Greenlee TA, George SZ, Pickens B, Rhon DI. Risk-stratified Care Improves Pain-related Knowledge and Reduces Psychological Distress for Low Back Pain: A Secondary Analysis of a Randomized Trial. Clin Orthop Relat Res. 2025 Apr 1;483(4):607-620. doi: 10.1097/CORR.0000000000003351. Epub 2025 Jan 21.
PubMed 39842027
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.
PubMed 37410465

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03127826
Acronym / sponsor ID: C.2016.047d
Conditions: Low Back Pain, Lumbago, Radiculopathy, Intervertebral Disc Disorder
Keywords: Low Back Pain, Risk-Stratified Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: Brooke Army Medical CenterUS federal agency
Study start: 7 Apr 2017 (actual)
Primary completion: 26 Feb 2021 (actual)
Study completion: 1 Jul 2021 (actual)
First posted: 25 Apr 2017 (actual)
Results: Posted 24 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Usual Care	Active comparator	Procedure: 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
Risk Stratified Care	Experimental	Procedure: 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

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Males and females who are between the ages of 18-50 years old
Primary complaint of LBP for any duration, with or without associated radiculopathy
Can speak and understand English
Be willing and able to give full, informed written consent

Key exclusion criteria (6 listed)

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
Spinal surgery in the past 24 months
Current pregnancy (or within the last 6 months)
Already receiving treatment (other than primary care) for this episode of LBP
Inability to attend regular treatment sessions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Risk Stratified CarePhysical 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	Procedure or surgery	Risk Stratified Care
Usual CareUsual care at the general practitioner's discretion	Procedure or surgery	Usual Care

Primary outcome

Roland-Morris Disability Questionnaire (RMDQ)
Time frame: 1 year
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

2 secondary outcomes

Patient Reported Outcomes Measurement Information System - Pain Interference
Time frame: 1 year
EuroQoL (EQ-5D)
Time frame: 1 year

Results and safety

Results posted to the registry on 24 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	145	145
Risk Stratified Care	145	145

Primary outcome: Roland-Morris Disability Questionnaire (RMDQ)

Time frame: 1 year. Least squares mean (95% Confidence Interval). Unit: points on a scale

Measure	Usual Care n = 134	Risk Stratified Care n = 136
Value	5.16 (4.37 to 6.09)	5.14 (4.36 to 6.07)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 145 (0%)	59 of 145 (40.7%)	0 of 145
Risk Stratified Care	0 of 145 (0%)	73 of 145 (50.3%)	0 of 145

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21963002Hill 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.
Background: PubMed 25098194Beneciuk 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.
Background: PubMed 22507360Main 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.
Background: PubMed 25858972Beneciuk 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.
Background: PubMed 27582134Saunders 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.
Derived from this study: PubMed 39842027Greenlee TA, George SZ, Pickens B, Rhon DI. Risk-stratified Care Improves Pain-related Knowledge and Reduces Psychological Distress for Low Back Pain: A Secondary Analysis of a Randomized Trial. Clin Orthop Relat Res. 2025 Apr 1;483(4):607-620. doi: 10.1097/CORR.0000000000003351. Epub 2025 Jan 21.
Derived from this study: PubMed 37410465Rhon 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.
Individual participant dataSharing planned: Yes. Data sharing must go through a Data Sharing Agreement via the Defense Health Agency

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel Rhon, DPT, DSc principal investigator

Director of Clinical Outcomes Research, Center for the Intrepid

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Risk Stratified Care in people with Low Back Pain and Lumbago, run by Brooke Army Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Roland-Morris Disability Questionnaire (RMDQ) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03127826, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.