Covid19NCT05012826
Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID
A study testing Osteopathic Manipulative Treatment in addition to Physiotherapy and Physiotherapy in people with Covid19 and SARS-CoV-2 Infection, run by Centro Universitário Augusto Motta at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19, SARS-CoV-2 Infection
- What is being tested?
- Osteopathic Manipulative Treatment in addition to Physiotherapy and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Sep 2021to 6 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Municipal de Reabilitação de Engenho de dentro
Rio de Janeiro, Rio de Janeiro, 22060-002
Ana Christina Ce Curi, MsC, 5521986095599, anaccuri@gmail.com
Ana Paula An Ferreira, PhD, 5521991134033, osteoferreira@gmail.com
About this study
Official title: Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID: Study Protocol for a Pragmatic Randomized Controlled SuperiorityTrial
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).
Read the detailed description
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.
- Conditions
- Covid19, SARS-CoV-2 Infection
- Being tested
- Osteopathic Manipulative Treatment in addition to Physiotherapy, Physiotherapy
- Keywords
- COVID-19, SARS-CoV-2, Physical Therapy Modalities, Osteopathic Manipulation, Rehabilitation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Treatment in addition to PhysiotherapyOther
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).
PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT)+ Physiotherapy (PT) Group | Experimental | Participants in this group will receive OMT in addition to the same interventions of PT group for the same 2- month period. 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). Receives: Other: Osteopathic Manipulative Treatment in addition to Physiotherapy; Other: Physiotherapy |
| Physiotherapy Group (PT) | Active comparator | 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 2 months. 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. the treatment provided will be registered on each participant's clinical notes and a summary of main interventions will be reported. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue Severity Scale: the scale consists of 9 items on how fatigue interferes with certain activities. Severity is classified according to a self-report scale. The scale consists of a 7-point score where 1 = strongly disagree and 7 = strongly agree. The minimum score is 9 and the maximum is 63. The higher the score is the greater the severity of fatigue (Krupp et al., 1989; Toledo et al., 2011). The Portuguese-Brazil version of FSS has high reliability (Cronbach's alpha = 0.93) and good construct validity with pain and fatigue instruments (Pearson correlation of 0.60 and 0.56, respectively)
Measured: 90 days
Functional status
The Post-COVID Functional State Scale : The scale has a score from 0 to 4 with 0 being no functional limitation and 4 severe functional limitation. In the present study, we will use the patient's flowchart and questionnaire with translation into Portuguese language (https://osf.io/qgpdv/) regarding his condition on the day of application (Klok et al., 2020).The Portuguese-Brazil version of PCFS has weak-to-strong construct validity (Pearson correlation in range 0.233 to 0.661) with health-related quality of life
Measured: 90 days
Secondary outcomes (1)
Global impression of recovery
The Perceived Change Scale (Patient Version): . It has 19 items, 18 of which assess the perceived changes related to: occupation and physical health, psychological dimension and sleep, relationships, and emotional stability, in addition to a last item that globally assesses the perceived change. Each item has 3-point Likert responses, where point 1 equates to worse than before, 2 to no change and 3 to better than before (Bandeira et al., 2011; Perreault et al., 2010).than before [43]. The Portuguese-Brazil version of EMP-patient has good internal consistency (Cronbach alpha = 0.85), test-retest temporal stability (Pearson correlation = 0.93) and convergent construct validity with a service satisfaction instrument (Pearson correlation = 0.37)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start20 Sep 2021
- Primary completion6 Jun 2023 (estimated)
- Study completion6 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, controlled, assessor-blinded, pragmatic randomized controlled superiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Brasileiro de Osteopatia
- Responsible party
- Sponsor
- Investigators
- Ana Christina Ce Curi, MsC, Principal investigator, Centro Universitário Augusto Motta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012826
- Sponsor's protocol ID
- 38342520.7.0000.5235
- Status last verified
- May 2023
- First submitted
- 16 Aug 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams J, Sibbritt D, Steel A, Peng W. A workforce survey of Australian osteopathy: analysis of a nationally-representative sample of osteopaths from the Osteopathy Research and Innovation Network (ORION) project. BMC Health Serv Res. 2018 May 10;18(1):352. doi: 10.1186/s12913-018-3158-y.
PubMed 29747647Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.
PubMed 11304107Alvarez G, Roura S, Cerritelli F, Esteves JE, Verbeeck J, van Dun PLS. The Spanish Osteopathic Practitioners Estimates and RAtes (OPERA) study: A cross-sectional survey. PLoS One. 2020 Jun 15;15(6):e0234713. doi: 10.1371/journal.pone.0234713. eCollection 2020.
PubMed 32542047Costa CS, Bandeira M, Cavalcanti RL, Scalon JD. [Perceptions by patients and families towards treatment outcomes in mental health services]. Cad Saude Publica. 2011 May;27(5):995-1007. doi: 10.1590/s0102-311x2011000500017. Portuguese.
PubMed 21655850Basile, F., Scionti, R., & Petracca, M. (2017). Diagnostic reliability of osteopathic tests: A systematic review. International Journal of Osteopathic Medicine, 25, 21-29. https://doi.org/10.1016/j.ijosm.2017.03.004
Bordoni B, Zanier E. Understanding Fibroblasts in Order to Comprehend the Osteopathic Treatment of the Fascia. Evid Based Complement Alternat Med. 2015;2015:860934. doi: 10.1155/2015/860934. Epub 2015 Aug 19.
PubMed 26357524Cerritelli F, Carinci F, Pizzolorusso G, Turi P, Renzetti C, Pizzolorusso F, Orlando F, Cozzolino V, Barlafante G. Osteopathic manipulation as a complementary treatment for the prevention of cardiac complications: 12-Months follow-up of intima media and blood pressure on a cohort affected by hypertension. J Bodyw Mov Ther. 2011 Jan;15(1):68-74. doi: 10.1016/j.jbmt.2010.03.005. Epub 2010 May 8.
PubMed 21147421Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884Dal Farra F, Risio RG, Vismara L, Bergna A. Effectiveness of osteopathic interventions in chronic non-specific low back pain: A systematic review and meta-analysis. Complement Ther Med. 2021 Jan;56:102616. doi: 10.1016/j.ctim.2020.102616. Epub 2020 Nov 13.
PubMed 33197571de Zoete A, de Boer MR, Rubinstein SM, van Tulder MW, Underwood M, Hayden JA, Buffart LM, Ostelo R; International IPD-SMT group. Moderators of the Effect of Spinal Manipulative Therapy on Pain Relief and Function in Patients with Chronic Low Back Pain: An Individual Participant Data Meta-analysis. Spine (Phila Pa 1976). 2021 Apr 15;46(8):E505-E517. doi: 10.1097/BRS.0000000000003814.
PubMed 33186277van Dun P.L.S., Kouwenberg T. (red.), 2012, The Scope of Osteopathic Practice in Europe, Brussels, European Federation of Osteopaths (EFO) & Forum for Osteopathic Regulation in Europe (FORE)van Dun P.L.S., Kouwenberg T. (red.), 2012, The Scope of Osteopathic Practice in Europe, Brussels, European Federation of Osteopaths (EFO) & Forum for Osteopathic Regulation in Europe (FORE)
Giusti, R. (2017). glossary OF OSTEOPATHIC TERMINOLOGY Third Edition.
Goodwin VA, Allan L, Bethel A, Cowley A, Cross JL, Day J, Drummond A, Hall AJ, Howard M, Morley N, Thompson Coon J, Lamb SE. Rehabilitation to enable recovery from COVID-19: a rapid systematic review. Physiotherapy. 2021 Jun;111:4-22. doi: 10.1016/j.physio.2021.01.007. Epub 2021 Feb 24.
PubMed 33637294Health, W. H. O., Programme, E., Panel, E. A., Preparedness, I. P. C., Guidance, I. P. C., Group, D., Gdg, I. P. C., Preparedness, S., & Plan, R. (2020). Transmission of SARS-CoV-2 : implications for infection prevention precautions. July, 1-10.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687.
PubMed 24609605
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID: Study Protocol for a Pragmatic Randomized Controlled SuperiorityTrial
- ClinicalTrials.gov ID
- NCT05012826
- Acronym / sponsor ID
- 38342520.7.0000.5235
- Conditions
- Covid19, SARS-CoV-2 Infection
- Keywords
- COVID-19, SARS-CoV-2, Physical Therapy Modalities, Osteopathic Manipulation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Collaborators
- Instituto Brasileiro de Osteopatia
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 6 Jun 2023 (estimated)
- Study completion
- 6 Jul 2023 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, controlled, assessor-blinded, pragmatic randomized controlled superiority trial
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT)+ Physiotherapy (PT) Group | Experimental | Other: Osteopathic Manipulative Treatment in addition to Physiotherapy, Other: PhysiotherapyParticipants in this group will receive OMT in addition to the same interventions of PT group for the same 2- month period. 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). |
| Physiotherapy Group (PT) | Active comparator | Other: PhysiotherapyParticipants 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 2 months. 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. the treatment provided will be registered on each participant's clinical notes and a summary of main interventions will be reported. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative Treatment in addition to PhysiotherapyParticipants 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 | Osteopathic Manipulative Treatment (OMT)+ Physiotherapy (PT) Group |
| PhysiotherapyParticipants 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. | Other | Osteopathic Manipulative Treatment (OMT)+ Physiotherapy (PT) Group, Physiotherapy Group (PT) |
Primary outcome
Fatigue
Time frame: 90 days
Fatigue Severity Scale: the scale consists of 9 items on how fatigue interferes with certain activities. Severity is classified according to a self-report scale. The scale consists of a 7-point score where 1 = strongly disagree and 7 = strongly agree. The minimum score is 9 and the maximum is 63. The higher the score is the greater the severity of fatigue (Krupp et al., 1989; Toledo et al., 2011). The Portuguese-Brazil version of FSS has high reliability (Cronbach's alpha = 0.93) and good construct validity with pain and fatigue instruments (Pearson correlation of 0.60 and 0.56, respectively)
Functional status
Time frame: 90 days
The Post-COVID Functional State Scale : The scale has a score from 0 to 4 with 0 being no functional limitation and 4 severe functional limitation. In the present study, we will use the patient's flowchart and questionnaire with translation into Portuguese language (https://osf.io/qgpdv/) regarding his condition on the day of application (Klok et al., 2020).The Portuguese-Brazil version of PCFS has weak-to-strong construct validity (Pearson correlation in range 0.233 to 0.661) with health-related quality of life
1 secondary outcome
Global impression of recovery
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 29747647Adams J, Sibbritt D, Steel A, Peng W. A workforce survey of Australian osteopathy: analysis of a nationally-representative sample of osteopaths from the Osteopathy Research and Innovation Network (ORION) project. BMC Health Serv Res. 2018 May 10;18(1):352. doi: 10.1186/s12913-018-3158-y.
- Background: PubMed 11304107Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.
- Background: PubMed 32542047Alvarez G, Roura S, Cerritelli F, Esteves JE, Verbeeck J, van Dun PLS. The Spanish Osteopathic Practitioners Estimates and RAtes (OPERA) study: A cross-sectional survey. PLoS One. 2020 Jun 15;15(6):e0234713. doi: 10.1371/journal.pone.0234713. eCollection 2020.
- Background: PubMed 21655850Costa CS, Bandeira M, Cavalcanti RL, Scalon JD. [Perceptions by patients and families towards treatment outcomes in mental health services]. Cad Saude Publica. 2011 May;27(5):995-1007. doi: 10.1590/s0102-311x2011000500017. Portuguese.
- BackgroundBasile, F., Scionti, R., & Petracca, M. (2017). Diagnostic reliability of osteopathic tests: A systematic review. International Journal of Osteopathic Medicine, 25, 21-29. https://doi.org/10.1016/j.ijosm.2017.03.004
- Background: PubMed 26357524Bordoni B, Zanier E. Understanding Fibroblasts in Order to Comprehend the Osteopathic Treatment of the Fascia. Evid Based Complement Alternat Med. 2015;2015:860934. doi: 10.1155/2015/860934. Epub 2015 Aug 19.
- Background: PubMed 21147421Cerritelli F, Carinci F, Pizzolorusso G, Turi P, Renzetti C, Pizzolorusso F, Orlando F, Cozzolino V, Barlafante G. Osteopathic manipulation as a complementary treatment for the prevention of cardiac complications: 12-Months follow-up of intima media and blood pressure on a cohort affected by hypertension. J Bodyw Mov Ther. 2011 Jan;15(1):68-74. doi: 10.1016/j.jbmt.2010.03.005. Epub 2010 May 8.
- Background: PubMed 23303884Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
- Background: PubMed 33197571Dal Farra F, Risio RG, Vismara L, Bergna A. Effectiveness of osteopathic interventions in chronic non-specific low back pain: A systematic review and meta-analysis. Complement Ther Med. 2021 Jan;56:102616. doi: 10.1016/j.ctim.2020.102616. Epub 2020 Nov 13.
- Background: PubMed 33186277de Zoete A, de Boer MR, Rubinstein SM, van Tulder MW, Underwood M, Hayden JA, Buffart LM, Ostelo R; International IPD-SMT group. Moderators of the Effect of Spinal Manipulative Therapy on Pain Relief and Function in Patients with Chronic Low Back Pain: An Individual Participant Data Meta-analysis. Spine (Phila Pa 1976). 2021 Apr 15;46(8):E505-E517. doi: 10.1097/BRS.0000000000003814.
- Backgroundvan Dun P.L.S., Kouwenberg T. (red.), 2012, The Scope of Osteopathic Practice in Europe, Brussels, European Federation of Osteopaths (EFO) & Forum for Osteopathic Regulation in Europe (FORE)van Dun P.L.S., Kouwenberg T. (red.), 2012, The Scope of Osteopathic Practice in Europe, Brussels, European Federation of Osteopaths (EFO) & Forum for Osteopathic Regulation in Europe (FORE)
- BackgroundGiusti, R. (2017). glossary OF OSTEOPATHIC TERMINOLOGY Third Edition.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Christina Ce Curi, MsC principal investigator
Centro Universitário Augusto Motta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in addition to Physiotherapy and Physiotherapy in people with Covid19 and SARS-CoV-2 Infection, run by Centro Universitário Augusto Motta at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arthur Sá Ferreira, PhD (5521999151800, arthur_sf@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05012826, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.