Table 2.
Summary of clinical activities in the visit-by-visit basis
| Visit | Activities | |
|---|---|---|
| Screening | Phone screen | Computer‒assisted telephone interview |
| Baseline visit 1 | Informed consent document | |
| Study flow chart | ||
| Study procedure video | ||
| HIPAA | ||
| Patient-centered outcomes | ||
| Past medical history | ||
| Medication checklist | ||
| Demographics & Vital signs | ||
| Examination | ||
| X-ray & Urinalysis, if indicated | ||
| Case review | ||
| Baseline visit 2 | Report of findings, enroll | |
| Treatment | Treatment visit 1 | Pre-treatment Pain in VAS |
| Physiological assessments | ||
| Treatment-full kinetics | ||
| Physiological assessments | ||
| Post-treatment pain in VAS | ||
| Treatment visit 2 | Pre-treatment pain in VAS | |
| Treatment | ||
| Post-treatment pain in VAS | ||
| Treatment visit 3 | Pre-treatment pain in VAS | |
| Treatment-simple kinetics | ||
| Post-treatment pain in VAS | ||
| Treatment visit 4 | Same as treatment visit 2 | |
| Treatment visit 5 | Same as treatment visit 1 | |
| Treatment visit 6 | Patient-centered outcomes | |
| Pre-treatment pain in VAS | ||
| Treatment | ||
| Post-treatment pain in VAS | ||
| Treatment visits 7-8 | Same as treatment visit 2 | |
| Treatment visit 9 | Same as treatment visit 3 | |
| Treatment visits 10-11 | Same as treatment visit 2 | |
| Treatment visit 12 | Same as treatment visit 1 | |
| Exit interview | Treatment visit 13 (Final) | Patient-centered outcomes |
| Satisfaction questionnaire | ||
| Exit interview |
HIPAA: Health Insurance Portability and Accountability Act; VAS: visual analog scale.