Table 3.
Schedule of assessments
| Measures | Enrollment | Baseline | 6 weeks | 12 weeks | 24 weeks |
|---|---|---|---|---|---|
| Screening and enrollment | |||||
| Eligibility screening | ✓ | ||||
| Informed consent | ✓ | ||||
| Baseline information | |||||
| Sociodemographics* | ✓ | ||||
| Expectations and preference | ✓ | ||||
| Back pain history and comorbidities | ✓ | ||||
| Primary outcomes | |||||
| Low back pain intensity (DVPRS) | ✓ | ✓ | ✓ | ✓ | |
| Back-related function (RMDQ) | ✓ | ✓ | ✓ | ✓ | |
| Secondary outcomes | |||||
| Pain medication use | ✓ | ✓ | ✓ | ✓ | |
| PTSD CheckList—Civilian version (PCL-C) | ✓ | ✓ | ✓ | ✓ | |
| Health-related quality of life (SF-12) | ✓ | ✓ | ✓ | ✓ | |
| Satisfaction with treatment | ✓ | ✓ | ✓ | ✓ | |
| Global improvement | ✓ | ✓ | ✓ | ||
| Cost-effectiveness outcomes | |||||
| Work productivity | ✓ | ✓ | ✓ | ✓ | |
| Medical utilization and cost | ✓ | ✓ | ✓ | ✓ | |
| Exploratory outcomes | |||||
| PROMIS-29 and pain interference | ✓ | ✓ | ✓ | ✓ | |
| Depression (PHQ-9) and anxiety (GAD-7) | ✓ | ✓ | ✓ | ✓ | |
| Relationship satisfaction (DAS) | ✓ | ✓ | ✓ | ||
| Pain self-efficacy (PSEQ) | ✓ | ✓ | ✓ | ||
| Sleep quality (PSQI) | ✓ | ✓ | ✓ | ||
| Coping strategies (CSQ) | ✓ | ✓ | ✓ | ||
| Post-concussive symptoms (NSI) | ✓ | ✓ | ✓ | ||
| Possible covariates and confounders | |||||
| Exercise history | ✓ | ✓ | ✓ | ✓ | |
| Low back pain treatments | ✓ | ✓ | ✓ | ✓ | |
| Alcohol, drugs, and smoking | ✓ | ✓ | ✓ | ||
*Sociodemographic information includes gender, age, relationship status, ethnicity, race, income, housing, education level, and military service history
DVPRS = Defense and Veterans Pain Rating Scale; RMDQ = Roland Morris Disability Questionnaire; PROMIS = Patient Reported Outcome Measurement Information System; SF-12 = Short Form 12-item Health Survey; PHQ-9 = 9-item Patient Health Questionnaire; GAD-7 = 7-item General Anxiety Disorder survey; DAS = Dyadic Adjustment Scale; PSQI = Pittsburgh Sleep Quality Index; NSI = Neurobehavioral Symptom Inventory