Adjunctive osteopathic therapy for hospitalized COVID-19 patients: A feasibility-oriented chart review study with matched controls

Participants

• Numbers: 179 people (92 women and 87 men)
• Criteria of inclusion: adults (age ≥18 years), Sars-Cov-2 infection (by laboratory test or based on manifested symptoms), respiratory distress status (increased respiratory fatigue, increased respiratory rate, need for oxygen), hospitalization between May 5, 2020 and June 7, 2020.
• Groups of study: 2 groups obtained by randomization
  • Group 1: OMT in addition to standard care, 27 people (16 women and 11 men, mean age 61.8 years)
  • Group 2: standard of care, 152 people (76 women and 76 men, mean age 62.3 years)

Interventions and evaluations

• Assessment of demographic data through medical records: age, sex, ethnicity, presence or absence of comorbidities (type 2 diabetes, cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease, obesity, sickle cell anemia, or immunocompromised states), temperature at admission, fever (≥38°C), oxygen saturation at admission, presence of pneumonia revealed by X-ray, testing for SARS-CoV-2, and, if available, laboratory tests (D-Dimer, alanine aminotransferase or ALT, aspartate aminotransferase or AST, C-reactive protein or CRP, ferritin, and procalcitonin) in the first 24 hours of admission.
• Assessment of OMT acceptance rate, patients’ perceived satisfaction using a 5-point Likert scale from -2 (very dissatisfied) to +2 (very satisfied), side effects and adverse events.
• Assessment of change in clinical status post-therapy by patient report obtained with the Clinical Global Improvement Item of the Clinical Global Impression Scale (7-point Likert scale from -3, i.e., much worse, to +3, i.e., much better), number of days of hospitalization, need for high-flow oxygen or CPAP/BiPAP during hospitalization (yes/no), admission to intensive care unit (yes/no), need for supplemental oxygen at discharge (yes/no), and type of discharge (home, rehabilitation facility, or death).
• Collection of physicians’ comments in relation to patients’ experience with OMT.
• If a patient was followed by an attending physician experienced in osteopathy, then OMT was offered on the first day of admission and during all subsequent days.
• OMT: 5-minute treatment developed by consensus-panel due to limited resources available
  • techniques used (considered most likely to achieve benefits): rib raising, abdominal diaphragm doming, thoracic pump and pedal pump.
• Standard of care: treatment administered according to the guidelines for the management of Covid-19.
• OMT performed by physicians trained in osteopathy in compliance with the protective protocols against Covid-19.

Results

Primary outcomes: a total of 52 OMT sessions were conducted, with 2 out of 27 people refusing to receive further treatment after the first session and 2 people going so far as to receive 5 OMT sessions. Overall, out of all sessions conducted, OMT was received as satisfactory (4.33 out of 5) and as helpful in improving patients’ health status (5.13 out of 7).
As side effects, 3 cases of self-limiting pain related to some osteopathic techniques were noted (2 cases after diaphragm treatment and 1 case after thoracic lymphatic pump techniques).
No adverse effects were noted.

Secondary outcomes: baseline, people who received OMT appear to have been hospitalized for less time than those who received only standard care (6.93 days vs. 8.63 days, with a p-value of 0.053 and an effect size — the magnitude of the treatment effect — small).
Further analysis showed that as comorbidities increased, receiving OMT tended to favor fewer inpatient days.
No differences emerged in relation to ICU admissions, oxygen need or discharge type.

Further analyses: the OMT group showed lower levels of AST and ferritin than the control group.
Regarding the physicians’ comments, it was found that OMT was well tolerated and, probably, patients agreed to receive it considering the deficiency of available therapies. Patients who experienced some side effects also viewed OMT as helpful. In addition, patients saw OMT as a “truce” from the isolating and frightening environment of the rest of the hospital. Finally, physicians reported that they were able to provide treatments with ease, and the Hospital itself expressed satisfaction for having been able to offer OMT.

Discussion

OMT was shown to be well accepted by patients and able to bring them relief, particularly in improving respiratory function. In addition, OMT appears to have promoted a reduction in the number of days of hospitalization, although more in-depth analysis is needed.

Obviously, given the small sample, the retrospective nature of the analysis and thus the inability to control for a number of confounding factors, these results should be taken with caution, although they encourage future studies.

However, the results are in line with previous studies that have shown the efficacy of OMT in reducing the days of hospitalization, with a consequent decrease in associated costs. Taking into account the expenses incurred during the pandemic period, even 1 or 2 days less per person could result in huge savings.

Moreover, the decrease in hospitalization days achieved with OMT is in line with, and in some cases even better than, the decrease induced by other therapies, including tocilizumab, anticoagulants, dexamethasone, and steroids. Only convalescent plasma (3.3 days) and remdesivir (5 days) showed convincingly better results.

Given the lack of adverse effects and its low cost, OMT may therefore prove particularly useful in resource-poor settings, particularly with patients with many comorbidities.

At the physiological level, OMT may have been found to be useful because of the effectiveness of the techniques used in improving breathing, stimulating the immune system, and promoting lymphatic drainage and, thus, the disposal and reduction of inflammatory cytokines.