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 |