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Table 3 Schedule of Enrollment, Intervention and Assessments

From: Effectiveness of spinal manipulation and biopsychosocial self-management compared to medical care for low back pain: a randomized trial study protocol

 

STUDY PERIOD

 

Eligibility

Enrollment & Allocation

Post-allocation

Timepoint

Initial Screen

Baseline/

Enrollment

(Day 0)

Inter-vention phase

(Months 0–2)

Weekly

Follow-Up

(Weeks 1–52)

Follow-Up

(Week 2)

Monthly

Follow-Up

(Months 1–12)

Follow-Up

(Month 1)

Follow-Up

(Month 2)

Follow-Up

(Month 6)

Follow-Up

(Month 12)

Informed consent

x

x

        

Demographics

x

x

        

Medical history & medications

 

x

        

Physical exam including objective outcomes

 

x

     

x

  

Inclusion/Exclusion criteria

x

x

        

Technology assessment**

 

x

        

Intervention administered all 4 arms (booster sessions allowable in month 3–12)

  

x

       

COVID − 19 impact

 

x

     

x

x

x

TUQ**

 

x

    

x

x

  

STarT Back screening tool status

x

      

x

x

x

Chronic LBP status (NIH research task force definition)

x

x

      

x

x

Chronic interference with daily activities

x

x

      

x

x

Low back pain intensity

x

x

 

x

      

Low back pain frequency

 

x

 

x

      

Pain trajectory

 

x

       

x

Implementation measures

x

x

     

x

x

x

Allocation/Randomization

 

x

        

Intervention uptake

       

x

x

x

Disability, PROMIS-29, healthcare and medication use, and productivity loss

 

x

   

x

    

Adverse events*

 

x

x

  

x

    

Satisfaction and global improvement

       

x

x

x

Healing Encounters and Attitudes List (HEAL) non-specific factors

 

x

  

x

 

x

x

x

x

Psychosocial mediators

(self-efficacy, coping, kinesiophobia, and pain catastrophizing)

 

x

     

x

x

x

Participant close out

         

x

  1. *Participants can also report adverse events to the PI’s or study staff at any point during the trial
  2. ** Technology Assessment and the Telehealth Usability Questionnaire (TUQ) will be administered to participants who are enrolled in the 2-arm study only. Tech Assessment may be administered to participants in the 4-arm study if applicable (e.g., preparing for a virtual SSM session)