Clinical Research Oriented Workshop (CROW) Meeting: Apr 9, 2020

Present:   Claudia Abbiati, Levi Bonnell, Justine Dee, Nancy Gell, Juvena Hitt, Ben Littenberg, Jen Oshita, Gail Rose, Connie van Eeghen, Adam Sprouse-Blum, Marian Wingood

1.                   Warm Up: Strategies for Zooming in and not getting frozen to a chair all day

2.                   Justine: Recruitment Change on IRB Protocol

a.       Switch to telehealth has made the protocol different, plus need to increase recruitment

                                                   i.      Completed 7 subjects out of 84 needed for power calculation (recruitment target is 100)

                                                 ii.      Opening population to any individual who has experienced physical or emotional trauma and has pain

1.       Determined by “Life events” checklist

2.       There is no defined threshold on the checklist; any item identified is a positive

                                               iii.      Pain: any pain?

1.       Not diabetic peripheral neuropathy, or dental pain, or IBS

2.       Yes: chronic musculoskeletal pain

                                               iv.      Recruit through public forums and provider referrals

                                                 v.      There is sufficient chronic pain in the population to yield enough participants for the study

                                               vi.      Outcome is physical function, not pain; trauma status will show up in this stratification

b.       Part of the protocol includes physical manipulation; could be self-application of cold or heat at home

                                                   i.      This works as an attention control; it is not the intervention

                                                 ii.      Doxy.me as the virtual platform of choice (not Zoom) – don’t restrict to one; does need video component

                                               iii.      What if participants don’t have access to heat/ice

                                               iv.      Consider “self-mobilization” or 15 minutes of stretching

                                                 v.      Might not be “usual care” but “bio-medical-based care” or “bio-psycho-social care”

                                               vi.      Remember to update ClinicalTrials.gov

                                              vii.      How might this change the research question?

1.       Is this a temporary move to telehealth?

2.       When physical restrictions on our society are lifted, will you go back to the original method?

3.                   4/16: Bring a piece of “home art” to share

a.       Future topics TBD