07/30/2023
Thoughts on Research, volume 1
After years of sharing information at conferences, in professional discussions with colleagues, and with people on social media, I’ve come to a somewhat distressing conclusion: very few of you understand how to conduct clinical research and how to critically read clinical research. I’m going to start a series of posts that will provide a basic framework for how to do a study on a specific topic that needs to be studied.
Study 1: evaluate the impact of bodywork (chiropractic, craniosacral therapy, and/or osteopathy) on the success of frenotomy.
Background information: Research has shown that mid-tongue elevation towards the palate is the key to obtaining a normal latch. While tongue tie can limit elevation, so can muscle tension. Additionally, clinical experience has demonstrated that wounds that are healing under adrenergic conditions (fight or flight stress hormones) heal worse than wounds who heal with less circulating stress hormone.
Objectives:
1. Determine if the addition of bodywork to frenotomy improves outcomes
2. Determine if bodywork improves breastfeeding quality even when frenotomy is not done.
How would you design such a study? First, assemble team members - lactation consultants, someone to do the procedure and bodyworker. One of the team members would be blinded to the presence or absence of bodywork. Then, you design the various arms of the study. All babies in the study should be tongue tied. Compare babies who had bodywork only vs babies who had frenotomy only vs babies who had bodywork and frenotomy.
Grade outcomes: Try to use validated measures. You could use a validated latch grading system. You could use validated patient questionnaires like the I-GERQ-R or GSQ-i (for reflux), the BSES-SF (maternal breastfeeding self-confidence), the VAS for ni**le pain, etc.
Other important steps - you’ll need to get IRB approval for the study. You’ll need a statistician. And you’ll need to build flexibility in your clinical schedule to allow the study patients to get in promptly. You’ll need to decide on when you’re going to grade the patients (pre/post intervention).
OK, now someone go do this study.
