| 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 | Â | Â | Â | Â | Â | Â | Â | Â |
Demographics | x | x | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history & medications | Â | x | Â | Â | Â | Â | Â | Â | Â | Â |
Physical exam including objective outcomes | Â | x | Â | Â | Â | Â | Â | x | Â | Â |
Inclusion/Exclusion criteria | x | x | Â | Â | Â | Â | Â | Â | Â | Â |
Technology assessment** | Â | x | Â | Â | Â | Â | Â | Â | Â | Â |
Intervention administered all 4 arms (booster sessions allowable in month 3–12) |  |  | x |  |  |  |  |  |  |  |
COVID − 19 impact |  | x |  |  |  |  |  | x | x | x |
TUQ** | Â | x | Â | Â | Â | Â | x | x | Â | Â |
STarT Back screening tool status | x | Â | Â | Â | Â | Â | Â | x | x | x |
Chronic LBP status (NIH research task force definition) | x | x | Â | Â | Â | Â | Â | Â | x | x |
Chronic interference with daily activities | x | x | Â | Â | Â | Â | Â | Â | x | x |
Low back pain intensity | x | x | Â | x | Â | Â | Â | Â | Â | Â |
Low back pain frequency | Â | x | Â | x | Â | Â | Â | Â | Â | Â |
Pain trajectory | Â | x | Â | Â | Â | Â | Â | Â | Â | x |
Implementation measures | x | x | Â | Â | Â | Â | Â | x | x | x |
Allocation/Randomization | Â | x | Â | Â | Â | Â | Â | Â | Â | Â |
Intervention uptake | Â | Â | Â | Â | Â | Â | Â | x | x | x |
Disability, PROMIS-29, healthcare and medication use, and productivity loss | Â | x | Â | Â | Â | x | Â | Â | Â | Â |
Adverse events* | Â | x | x | Â | Â | x | Â | Â | Â | Â |
Satisfaction and global improvement | Â | Â | Â | Â | Â | Â | Â | x | x | x |
Healing Encounters and Attitudes List (HEAL) non-specific factors | Â | x | Â | Â | x | Â | x | x | x | x |
Psychosocial mediators (self-efficacy, coping, kinesiophobia, and pain catastrophizing) | Â | x | Â | Â | Â | Â | Â | x | x | x |
Participant close out | Â | Â | Â | Â | Â | Â | Â | Â | Â | x |