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Table 2 Schedule of Research Assessments

From: The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain

Measure

Assessment Time Point

Pre-screening

Baseline

10 Weeks

6 Months

12 Months

Eligibility questions

 

X

   

Informed consent form

 

X

   

Baseline patient form

 

X

   

Baseline researcher form

 

X

   

Randomization

 

X

Xa

  

Follow-up researcher form

  

X

  

Oswestry Disability Index

Xb

Xb

X

X

X

Numerical Pain Rating Scale

Xb

Xb

X

X

X

STarT Back Screening Tool

 

X

X

X

X

PROMIS domain

     

 Anxiety

 

X

X

X

X

 Depression

 

X

X

X

X

 Pain interference

 

X

X

X

X

 Sleep disturbance

 

X

X

X

X

 Social roles and activities

 

X

X

X

X

Treatment forms

  

X

X

 

Adverse effects questionnaire

  

X

X

 

Healthcare and opioid use

 

X

X

X

X

  1. PROMIS, Patient Reported Outcome Measurement Information System
  2. aOnly if deemed “nonresponder” to phase-1 treatment
  3. bTo be administered at pre-screening assessment and repeated at baseline assessment only if > 14 days have passed since pre-screening