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Patient Perception of Clinical Trials With and Without Osteopathic Manipulative Treatment During the COVID-19 Pandemic
Nikakis, J. [7]
Singh Arora, U. [1]
Wang, L. [2]
Abramowitz, C. [1]
Malkov, D. [7]
Cohen, T. J. [9]

Journal: Journal of Osteopathic Medicine Date: 2021/12, 121(12):Pages: A50-A52. doi: Subito , type of study: cross sectional study

Full text    (https://www.degruyter.com/document/doi/10.1515/jom-2021-2000/html)

Keywords:

covid-19 [139]
cross sectional study [881]
OMT [3855]
osteopathic manipulative treatment [3876]
patients [161]
research [469]
research participation [1]
USA [1736]

Abstract:

Context: During the COVID-19 pandemic, many medical facilities that were providing hands-on therapy, such as Osteopathic Manipulative Therapy (OMT), had to discontinue or limit operations for safety purposes. Not much is known about whether the resumption of hands-on treatment has been met with enthusiasm, reluctance, or indifference by patients, and if these dispositions are influenced by vaccination or infection status. Objective: To test the hypothesis that patients are more hesitant to participate in clinical trials with and without OMT during a pandemic as opposed to before the pandemic. In addition, this study will test the hypothesis that perceived immunity (through prior COVID-19 infection or vaccination) will enhance agreement to participate in clinical trials with or without OMT. Methods: Clinical trials are an important tool used to understand the effects OMT has on human physiology. Following the COVID-19 pandemic, patients may have increased reluctance to receive OMT. To study this potential effect, 35 surveys were handed out to patients at the Long Island Heart Rhythm Center (LIHRC) at NYIT College of Osteopathic Medicine between June and July of 2021. The surveys were used as a screening tool for the ongoing IRB-approved study Effects of Osteopathic Manipulative Therapy on Arrhythmias (BHS-1464). In our survey study, cardiology patients answered five questions: (1) Have you ever tested positive for COVID-19? (2) Have you received at least one dose of a COVID-19 vaccine? (3) Are you willing to participate in a clinical trial? (4) Are you willing to participate in a clinical trial with Osteopathic Manipulative Therapy from a physician? (5) If you answered “No” or “Maybe” to question #4, would you have participated in a clinical trial with hands-on treatment from a physician before the onset of the COVID-19 pandemic? The answer choices for questions 1 and 2 were “Yes” or “No,” and for questions 3-5 the answer choices were “Yes,” “No,” or “Maybe.” Additionally, under questions 3-5 there was a section to leave comments if the patient chose “Maybe.” A quantitative analysis was performed on the data to make conclusions about patient outlook on clinical and OMT trials. Results: Out of the 35 patients surveyed, 29 patients received at least one dose of a COVID-19 vaccine, 6 patients previously contracted COVID-19, 3 patients did not have a COVID-19 vaccination or previous infection, and 2 patients received a COVID-19 vaccination and previously contracted COVID-19. 20 patients were willing to participate in a clinical trial, 21 were willing to participate in a clinical trial with OMT, and 29 would have participated in a clinical trial with OMT before the pandemic. Previously Infected (n=6): 5 patients were willing to participate in a clinical trial, and 4 were willing to participate in a trial with OMT. 2 patients would not participate currently or prior to the pandemic. Not Previously Infected (n=29): 15 patients were willing to participate in a clinical trial, and 17 were willing to participate in a trial with OMT. Out of the 12 patients who were unsure or would not currently participate, 8 reported that they would have participated in an OMT trial prior to the pandemic. Vaccinated (n=28, includes patients who have also tested positive for COVID-19): 15 patients were willing to participate in a clinical trial, and 17 were willing to participate in a trial with OMT. Out of the 13 patients who were unsure or would not currently participate, 7 reported that they would have participated in an OMT trial prior to the pandemic. Not vaccinated (n=7): 5 patients were willing to participate in a clinical trial, and 4 were willing to participate in a trial with OMT. Out of the 3 patients who were unsure or would not currently participate, 1 reported that they would have participated in an OMT trial prior to the pandemic. Conclusion: This study demonstrates that more than half of the cardiology clinic patients surveyed were willing to participate in clinical trials with and without OMT. More than 20 percent of the participants that would not currently participate would have participated in a clinical trial with OMT before the pandemic. Preliminary results appear to indicate that there is no difference between patients’ willingness to participate in clinical trials with and without OMT, regardless of vaccination and previous COVID-19 infection status. Two patients indicated concern over clinical trials involving new medications and dangerous procedures, however, they were willing to participate in an OMT clinical trial. 74 percent of patients in our survey were vaccinated and did not have a previous COVID-19 infection. The sample size of patients without vaccinations and/or prior COVID-19 infection was too small for a statistical comparison. Additional patient recruitment is needed in order to truly determine whether there is a difference in participation in clinical trials between those with perceived immunity and those without. Further recruitment is also necessary to assess the effect of the COVID-19 pandemic on patients’ dispositions towards participating in both clinical and OMT trials.

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