Skip to main content
. 2023 May 25;24:415. doi: 10.1186/s12891-023-06549-w

Table 3.

Schedule of Enrollment, Intervention and Assessments

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

*Participants can also report adverse events to the PI’s or study staff at any point during the trial

** 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)