We have revised our study design according to IRB's comments. The protocol has recently been approved. It was listed in the ClinicalTrials.gov. We have just started patient recruitment and screening. The patient blood samples will be collected according to the following plan: A total of eight visits will be required for all participants enrolled in this study. At the Day 1 baseline visit, all participants will receive 30 minutes of quiet relaxation. Participants will lie down on the treatment bed in the room where acupuncture/sham treatment will be carried out for 30 minutes without any activity. At the Day 3 visit, all participants will receive 30 minutes of sham acupuncture treatment. Participants will go through the acupuncture treatment procedure without insertion or manipulation of needles. Previous study indicates that subjects in acupuncture studies generally cannot distinguish sham from real acupuncture treatment when points on the leg or back are used. Since all points that will be used in our treatment are on the back, we believe that the sham treatment will serve as a control to real acupuncture treatment. These two visits serve as environmental and sham acupuncture controls as previous studies have indicated placebo effects of the sham and non-point treatments. The total estimated time per study visit is one hour. After the first two visits, participants will receive six acupuncture treatments over a two week period. A licensed and experienced acupuncture specialist, will perform a standard acupuncture procedure for LBP. The BPI-SF and RMDQ will be answered by all participants before each study treatment. Blood will be collected before and after the quiet relaxation, before and after the sham acupuncture and before and after the acupuncture treatment on Day 1, Day 3 and Day 5, respectively. On Day 17, blood will be collected only after acupuncture treatment. For each blood collection, 45 mL of blood will be collected. Forty (40) mL of blood will be collected in four 10 mL heparinized blood collection tubes, and 5 mL of blood will be collected in one 8 mL Vacutainer SST tube according to the manufacturers recommended procedure (BD). On Days 1, 3 and 5, therefore, a total of 90 mL of blood will be collected over the course of the study visit. On Days 17, blood will not be collected before the treatment, but 45 mL of blood will be collected post-treatment.
|Wei, Lai; Chen, Ping; Lee, Joo Hyun et al. (2013) Genetic and Epigenetic Regulation in Age-related Macular Degeneration. Asia Pac J Ophthalmol (Phila) 2:269-274|