Background: Fatigue is among the most common symptoms of the long-term effects of coronavirus (long COVID). This study aims to compare the effectiveness of osteopathic manipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PT alone on fatigue and functional limitations after two months post randomization in adults with long COVID. Methods: This is a study protocol for a two-arm, assessor-blinded, pragmatic randomized controlled superiority trial. Seventy-six participants will be randomly allocated to OMT+PT or PT. The PT includes usual care interventions including motor and respiratory exercises targeting cardiorespiratory and skeletal muscle functions. The OMT entails direct, indirect, visceral, and cranial techniques. Patients will be evaluated before and after a 2-month intervention program, and at 3-month follow-up session. Primary objectives comprise fatigue and functional limitations at 2-month post randomization as assessed by the fatigue severity scale and the Post-COVID Functional State scale. Secondary objectives comprise fatigue and functional limitations at 3 months, and the perceived change post-treatment as assessed by the Perceived Change Scale (PCS-patient).
The coronavirus disease caused by the severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2)-COVID-19-is causing a substantial increase in hospitalizations leading to
overloads in global health systems. Long-term effects of coronavirus-long COVID-comprise of
the effects of COVID-19 that lasts for weeks or even months beyond the acute infection. Long
COVID includes a wide spectrum of respiratory, neurologic, cardiovascular, gastrointestinal,
and musculoskeletal symptoms, and an increased risk of death. There are more than 50 known
possible sequelae in long COVID, such as chronic fatigue, and the clinical manifestations may
persist for weeks after the acute infection [6], leading to a decrease in quality of life.
This condition reinforces the demand for healthcare and the need for a comprehensive approach
for patients with long COVID.
Physiotherapy interventions may be required for patients with long COVID aiming to manage
symptoms, prevent and restore the patients' functional status and enabling them to perform
activities of daily living. The physiotherapy approach for patients with long COVID includes
motor and respiratory rehabilitation aiming at maintaining and/or improving joint mobility,
muscle strength, and functional capacity. A systematic review highlighted that to improve the
rehabilitation in patients, especially in older adults with a severe respiratory illness on
admission and after post ICU, some exercise regimens and habits can bring hope, confidence,
and functional independence. The authors suggest this may be generalized to those treated for
COVID-19, but maybe with personalized care. However, there is a lack of consensus on outcomes
measures.
Osteopathy is a healthcare system that aims to promote the balance of physiological function,
support homeostasis and encourage wellbeing. In 1918, during the Spanish flu in the United
States, osteopathy presented itself as one of the health resources made available to help
fight the epidemic. In 2007, OMT once again presented itself as a possibility to help restore
health to individuals affected by the H5N1 avian flu. It is worth noticing though these
studies are of the lowest evidence, often collections of research that is not directly
relevant to the condition and with no indication of clinical relevance; also, most of them
comprise hypothetical opinions on this matter. Studies on the OMT combined with standard
medical care show that OMT can collaborate in the recovery of health in various clinical
conditions, including shortening the length of stay and in-hospital mortality rates in the
elderly with more severe pneumonia. Altogether, the interest in the field but absence of
reliable data justified an effort to assess the effects of OMT on fatigue in people with long
COVID. If found effective, OMT may be recommended as an adjunct to other interventions for
this population.
Fatigue is one of the most common and persistent sequelae in long COVID. Fatigue is often a
disabling symptom related to several clinical conditions related to systemic inflammatory
processes. Pain and fatigue, for example, may overlap, suggesting that biological mechanisms,
which include peripheral and central components, and identifiable neuronal networks, are
present in both conditions. In a systematic review of the effects of OMT on chronic
inflammatory diseases, the data proved inconsistent but safe, suggesting more robust trials
are warranted. Hence, the primary aim of this trial is to test whether OMT combined with PT
(OMT+PT) is superior to PT alone on fatigue and functional limitations two months post
randomization in adults with long COVID. Secondarily, this trial will investigate the
effectiveness of OMT+PT and PT alone on fatigue, functional status, and perceived change
post-treatment 3 months post-randomization in this population.
Other: Osteopathic Manipulative Treatment in addition to Physiotherapy
Participants in this group will receive OMT in addition to the same interventions of PT group. The frequency of treatment will be decided based on the clinical judgment of the osteopath who is accompanying each case, not exceeding 7 consultations in total. At each visit, the participants will receive a full-body osteopathic examination which include clinical exams, observation, screening tests, palpation, and motion testing. The OMT entail direct (high-velocity low-amplitude; muscle energy; and myofascial release), indirect (functional techniques and balanced ligamentous tension), visceral, and cranial techniques(Giusti, 2017). Selection of specific OMT will follow the 'TART' criteria-Tissue texture changes, Asymmetry, Restriction of motion, Tenderness (Basile et al., 2017; Cerritelli et al., 2011; Giusti R., 2017; Pizzolorusso et al., 2011; Seffinger M.A, 2018).
Other: Physiotherapy
Participants in this group will receive physiotherapy sessions with a maximum frequency of 2 weekly sessions, as defined by the physiotherapist, according to personalized therapeutic plans for a period of 8 weeks. The physiotherapy approach for patients with long COVID includes motor and respiratory rehabilitation aiming at maintaining and/or improving joint mobility, muscle strength, and functional exercise capacity (Thomas et al., 2020). At each visit, the participants respond by self-report about their general condition. Depending on the case, the physiotherapist will perform a reevaluation with specific tests. The PT group will receive physiotherapy treatment offered by five physiotherapists, with more than 5 years of experience each, duly registered with their class council.
Inclusion Criteria: comprise age equal to or above 18 years; essential and clinical
criteria for long COVID at baseline assessment (confirmed preceding infection with
SARS-CoV-2, individuals referred for rehabilitation reporting fatigue as major symptom
[35]; and ability to understand Portuguese well enough to be able to fill in the
questionnaires
Exclusion Criteria: comprise conditions in which fatigue is also a major complain such as
suspected or diagnosed chronic and/or neurological diseases (e.g., Parkinson's disease,
amyotrophic lateral sclerosis, Alzheimer's disease); pre-existing, chronic diseases
affecting the musculoskeletal system (e.g., fibromyalgia).
Hospital Municipal de Reabilitação de Engenho de dentro
Rio de Janeiro, RJ, Brazil
Investigator: Ana Christina Ce Curi, MsC
Contact: 5521986095599
anaccuri@gmail.com
Arthur Sá Ferreira, PhD
5521999151800
arthur_sf@icloud.com
Ana Paula An Ferreira, PhD
5521991134044
osteoferreira@gmail.com
Ana Christina Ce Curi, MsC, Principal Investigator
Centro Universitário Augusto Motta