Validation of the STarT Back Screening Tool in the Military

NCT03127826 | Completed

• 1 other identifier: C.2016.047d
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Lumbago; Radiculopathy; Intervertebral Disc Disorder

Keywords

Low Back Pain; Risk-Stratified Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient Acceptable Symptom Scale (PASS)

  1 year

• Credibility Expectancy Questionnaire (CEQ)

  1 year

• Patient Reported Outcomes Measurement Information System 57-Item Profile v 2.0 (PROMIS-57)

  1 year

• EuroQoL (EQ-5D)

  1 year

• Healthcare Utilization

  2 years

Study Arms (2)

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

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

Procedure: Risk Stratified Care

Interventions

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

Risk Stratified Care

Usual Care PROCEDURE

Usual care at the general practitioner's discretion

Usual Care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

Location

Related Publications (6)

• 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.

  PMID: 21963002 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.

  PMID: 25098194 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.

  PMID: 22507360 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.

  PMID: 25858972 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.

  PMID: 27582134 BACKGROUND

• 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.

  PMID: 37410465 DERIVED

MeSH Terms

Conditions

Low Back Pain; Radiculopathy; Intervertebral disc disease

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Daniel Rhon, DPT, DSc

  Director of Clinical Outcomes Research, Center for the Intrepid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Primary care providers will be unaware of risk stratification scores.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Outcomes Research at the Center for the Intrepid

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 25, 2017
• Study Start: April 7, 2017
• Primary Completion: February 26, 2021
• Study Completion: July 1, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Usually the Data Sharing Agreement with the Defense Health Agency is good for 1 year. But the terms are all unique and contract-specific.
• Access Criteria: Through a proper Data Sharing Agreement Application (DSAA) with the US Defense Health Agency

Locations

US (1)