Primary Outcome Variable The primary outcome variable was patient-reported pain on the pain VAS. The pain VAS was designed to permit a thorough and understandable subjective assessment of pain. The pain VAS consists of a 10-cm horizontal line, with marks at both ends to define the limits of the pain experience as “no pain” (0) and “maximum pain experienced” (10), with higher scores indicating greater pain. Patients were asked to evaluate the overall pain experienced that caused them to seek treatment. The psychometric usefulness of the VAS for pain measurement has been widely demonstrated. Clinically important improvement on the pain VAS is considered to be 1.5 points.