Validation of the STarT Back Screening Tool in the Military

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127826
• Other study ID #: C.2016.047d
• Status: Completed
• Phase: N/A
• Start date: April 7, 2017
• Est. completion date: July 1, 2021

Study information

• Verified date: May 2022
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: July 1, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Intervertebral Disc Disorder
• Low Back Pain
• Lumbago
• Radiculopathy

Intervention

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
• Usual Care
Usual care at the general practitioner's discretion

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland-Morris Disability Questionnaire (RMDQ)	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]	1 year
Secondary	Patient Acceptable Symptom Scale (PASS)	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."	1 year
Secondary	Credibility Expectancy Questionnaire (CEQ)	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.	1 year
Secondary	Patient Reported Outcomes Measurement Information System 57-Item Profile v 2.0 (PROMIS-57)	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.	1 year
Secondary	EuroQoL (EQ-5D)	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.	1 year
Secondary	Healthcare Utilization	Low back pain related healthcare costs	2 years