Study design

Each participant signed an informed consent document before data collection. At the first visit, they completed a demographic survey and the SF-12v2. The administration of the SF-12v2 followed all guidelines outlined in the user's manual.¹⁹ Salivary samples were collected immediately before the first treatment, after the first UCAT treatment at the CCJ after a 30-minute rest, and at the end of the 2-week period. The UCAT performed was Atlas Orthogonal, Blair, Knee Chest, National Upper Cervical Chiropractic Association (NUCCA), or Orthospinology, depending on which doctor the participant saw, because each doctor in the study practiced a different UCAT. Each UCAT has its own standardized protocol,¹⁴ which was strictly followed by each doctor. SIgA levels demonstrate circadian variation,^3,4 so each follow-up sample was collected within a 2-hour range centered on the time of the initial sample. For example, if the participant's initial sample was collected at 10 am, each follow-up sample was collected within 1 hour before or after 10 am. There were 5 visits for each participant within a 2-week period, including the initial visit. At each visit, the investigator examined the participant to ascertain whether or not an additional treatment was required, following the protocols designated by the respective UCAT. Each participant completed the SF-12v2 again at the end of the 2-week period.

All clinical data collected related to this project were stored on paper documents. These documents included the informed consent, inclusion/exclusion checklist, SF-12v2, and daily-visit checklists, which indicated the procedures performed at each visit. These were stored in a secure file until the completion of the project, at which time they were copied and sent to the statistician for processing. Each document was identifiable only by the same alphanumeric identifier that was associated with that participant's saliva sample, so that the statistician was blinded to the identity of any participant.