Background: Fatigue is among the most common symptoms of the long-term effects ofcoronavirus (long COVID). This study aims to compare the effectiveness of osteopathicmanipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PTalone on fatigue and functional limitations after two months post randomization in adultswith long COVID.Methods: This is a study protocol for a two-arm, assessor-blinded, pragmatic randomizedcontrolled superiority trial. Seventy-six participants will be randomly allocated toOMT+PT or PT. The PT includes usual care interventions including motor and respiratoryexercises targeting cardiorespiratory and skeletal muscle functions. The OMT entailsdirect, indirect, visceral, and cranial techniques. Patients will be evaluated before andafter a 2-month intervention program, and at 3-month follow-up session. Primaryobjectives comprise fatigue and functional limitations at 2-month post randomization asassessed by the fatigue severity scale and the Post-COVID Functional State scale.Secondary objectives comprise fatigue and functional limitations at 3 months, and theperceived 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