Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID

NCT05012826 | Unknown

• 1 other identifier: 38342520.7.0000.5235
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Covid19; SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2; Physical Therapy Modalities; Osteopathic Manipulation; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  90 days

Secondary Outcomes (1)

• Global impression of recovery

  90 days

Study Arms (2)

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).

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.

Other: Physiotherapy

Interventions

Osteopathic Manipulative Treatment in addition to Physiotherapy OTHER

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).

Osteopathic Manipulative Treatment (OMT)+ Physiotherapy (PT) Group

Physiotherapy OTHER

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.

Osteopathic Manipulative Treatment (OMT)+ Physiotherapy (PT) Group; Physiotherapy Group (PT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead
• Instituto Brasileiro de Osteopatia: collaborator

Study Sites (1)

Hospital Municipal de Reabilitação de Engenho de dentro

Rio de Janeiro, Rio de Janeiro, 22060-002, Brazil

RECRUITING

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MeSH Terms

Conditions

COVID-19

Interventions

Manipulation, Osteopathic; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Rehabilitation

Study Officials

• Ana Christina Ce Curi, MsC

  Centro Universitário Augusto Motta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur Sá Ferreira, PhD

CONTACT

5521999151800; arthur_sf@icloud.com

Ana Paula An Ferreira, PhD

CONTACT

5521991134044; osteoferreira@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure the expectation of treatment is equally balanced between the groups the participants will not be aware of the study hypothesis regarding the between-group comparisons. It is not possible to blind the clinicians regarding the groups and the participants regarding their treatment. The outcome assessor and statistician will be blind to the allocations of groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, controlled, assessor-blinded, pragmatic randomized controlled superiority trial

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 19, 2021
• Study Start: September 20, 2021
• Primary Completion: June 6, 2023
• Study Completion: July 6, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)