Validation of the STarT Back Screening Tool in the Military
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|ClinicalTrials.gov Identifier: NCT03127826|
Recruitment Status : Active, not recruiting
First Posted : April 25, 2017
Last Update Posted : July 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Lumbago Radiculopathy Intervertebral Disc Disorder||Procedure: Risk Stratified Care Procedure: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||290 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Masking Description:||Primary care providers will be unaware of risk stratification scores.|
|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|
|Actual Study Start Date :||April 7, 2017|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||July 1, 2021|
Active Comparator: Usual Care
Procedure: Usual Care
Usual care at the general practitioner's discretion
Experimental: Risk Stratified Care
Medium Risk and High Risk
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).
- Reassurance will be provided to address specific concerns related to their LBP and implications on work
- 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
- Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: 1 year ]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]
- Patient Acceptable Symptom Scale (PASS) [ Time Frame: 1 year ]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."
- Credibility Expectancy Questionnaire (CEQ) [ Time Frame: 1 year ]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.
- Patient Reported Outcomes Measurement Information System 57-Item Profile v 2.0 (PROMIS-57) [ Time Frame: 1 year ]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.
- EuroQoL (EQ-5D) [ Time Frame: 1 year ]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.
- Healthcare Utilization [ Time Frame: 2 years ]Low back pain related healthcare costs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127826
|United States, Texas|
|Brooke Army Medical Center|
|San Antonio, Texas, United States, 78219|
|Principal Investigator:||Daniel Rhon, DPT, DSc||Director of Clinical Outcomes Research, Center for the Intrepid|