Optimizing Treatment Sequencing for Patients with Chronic, - - PowerPoint PPT Presentation

Optimizing Treatment Sequencing for Patients with Chronic, Nonspecific Low Back Pain

Julie Fritz, PhD, PT

Distinguished Professor, Department of Physical Therapy & Athletic Training, University of Utah September 19, 2019

@jfritzPT

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Julie Fritz

• Has nothing to disclose.

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Study Overview

PCORI Priority Research Question: What is the comparative effectiveness

• f optimized, multidisciplinary nonsurgical treatments involving combined or

sequenced interventions for patients with nonspecific chronic LBP?

OPTIMIZE LBP Study: Optimizing treatment sequencing for patients with chronic, non-specific low back pain

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Study Overview

• Collaboration among 3 Healthcare Systems
• Pragmatic Trial using sequential multiple assignment

randomization trial (SMART) design

• Recruiting 945 patients with chronic LBP seeking healthcare
• Age 18-64
• Moderate pain and disability
• Not currently receiving a study intervention for back pain
• No back surgery in past year

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Evidence Gaps Addressed by Study

• Multiple non-pharmacologic treatments are beneficial for chronic LBP

– BUT…

• Characterized by Small Treatment Effects
• Direct Comparisons Between Treatments often Equivocal
• Little Guidance on Which Treatments Work for Which Patients
• Prior Research has not Examined the Question of How to Sequence

Treatments and What to Advise When a Patient Fails to Respond

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Effects of nonpharmacological interventions for chronic LBP compared to usual care, placebo or control

AHRQ Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review

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Evidence Gaps Addressed by Study

• Patient Stakeholder Input –
• 9 individuals with chronic LBP
• Key themes:
• Frustration: “pain is a powerful overseer, you are willing to try anything that

might help… You just don’t know what to do.”

• Transition from expecting a “fix” towards managing symptoms: “Initially my

goal was to get rid of it, now I just want to be able to function.”

• Connected pain to mood/stress: It’s a loop, goes from stress causing pain to

pain causing stress and repeats”

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Evidence Gaps Addressed by Study

• There is no singular effective treatment for chronic LBP.
• Past studies have not examined the effect of how treatments are

sequenced.

• Past studies have examined a fixed treatment regimen, without

adaptation to an individual patient’s response.

• Past studies have not had enough participants to rigorously examine

which treatment works for what type of patient.

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Aims of the OPTIMIZE Study

• Goal: examine common non-pharmacologic treatments with

evidence of benefit:

• Cognitive Behavioral Therapy
• Physical Therapy
• Mindfulness-Oriented Recovery Enhancement (MORE)
• Primary Outcomes:
• Function
• Pain intensity

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Exploratory Aim 4 Test 4 Adaptive Treatment Regimens:

1) Start with PT, Switch to CBT if non- responder 2) Start with PT, Switch to Mindfulness if non-responder 3) Start with CBT, Switch to PT if non- responder 4) Start with CBT, Switch to Mindfulness if non-responder

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Methodologic Challenges and Lessons Learned

• Explaining the design to

potential participants.

• Acceptability to patients of

possibly changing providers after 8 weeks.

• Total treatment time

(particularly for Phase 1 non- responders)

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Potential Impact on Practice

• No prior trials compare CBT and PT for chronic LBP;
• with sufficient sample size to examine heterogeneity of effects.
• Patient and provider communication around changing treatment

strategies based on responsiveness.

• Pre-planning how to assess responsiveness and modify treatment

accordingly

• Opportunities to align payer financial incentives with evidence-

based, non-pharmacologic, treatment strategies.

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Learn More

• www.pcori.org
• info@pcori.org
• #PCORI2019
• Optimize Trial

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Questions?

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Thank You!

Julie Fritz

Distinguished Professor, Department of Physical Therapy & Athletic Training, University of Utah @jfritzPT September 19, 2019