Fascial Tissue Response to Manual Therapy: Implications in Long COVID-19

According to the World Health Organization (WHO), as of mid-September 2022, more than 21 million Brazilians have recovered from COVID-19. However, post-infection symptoms continue to appear months after the end of the acute infection, a syndrome called long COVID. Therefore, the aim of this study is to investigate the responses of fascia-focused manual therapy in participants with long COVID.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Guidebook; Other: Guidebook and Myofascial Reorganization® (RMF).

Detailed Description

Participants reported to have long COVID, of both sexes, aged between 20 and 80 years, from the community, outpatient clinics and hospitals will be evaluated. The treatment of participants will be carried out at the CEFID-UDESC Physiotherapy School Clinic, where they will undergo assessment of the biomechanical and viscoelastic properties of tissues, postural control, pain and quality of life. For normality analysis, the Shapiro-Wilk test will be applied, and according to the distribution of the data, parametric or non-parametric tests will be used. Pre- and post-assessment and treatment data will be compared using descriptive statistics and Student's t-test with a significance level of p=0.05 for parametric data or Wilcoxon for non-parametric data.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larissa Sinhorim; Phone Number: 47984057340; Email: larissasinhorim@hotmail.com

Study Locations

• Brazil
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil, 88.035-001
      • Recruiting
      • Santa Catarina State University
      • Contact: Larissa Sinhorim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants diagnosed with long COVID, of both sexes, aged between 20 and 80 years, from the community, outpatient clinics and hospitals.

Exclusion Criteria:

• Participants with suspected deep vein thrombosis; Participants with neurological disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Guidebook	Other: Guidebook; Folder that will be given to the participant to carry out 5 minutes of intervention daily
Experimental: Guidebook and Myofascial Reorganization® (RMF).	Other: Guidebook and Myofascial Reorganization® (RMF).; The intervention will be carried out once a week for 30 minutes for 6 weeks. It will include passive, active-assisted moments (with and without load). In addition to a folder that will be given to the participant to carry out 5 minutes of intervention daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functioning and disability	Will be assessed using the "World Health Organization Disability Assessment" questionnaire (WHO-DAS 2.0), translated and validated for the Brazilian population by Silveira et al. (2013).	6 weeks
Biomechanical and tissue viscoelastic properties	Will be evaluated by MyotonPro (MytonPro, Myoton Ltd.s., Tartu, Estonia)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work capacity	Will be assessed by the "Work Limitations Questionnaire, WLQ-25" translated and validated for the Brazilian population by Soárez et al (2007).	6 weeks
Upper limb dysfunctions	Will be assessed using the Arm, Shoulder and Hand Dysfunctions questionnaire (DASH), translated and validated for the Brazilian population by Orfale et al (2005).	6 weeks
Balance	Will be assessed using the Neurocom Balance Platform (VRS Sport) and its NeuroCom®Balance Manager program (Neurocom International, Inc, Clackamas, OR).	6 weeks
Level of Quality of life	Will be assessed by the "World Health Organization Questionnaire" in its short version, validated in the Brazilian population and by the "Medical Outcomes Study 36-Item Short Form Health" questionnaire Survey" validated for Brazilian-Portuguese.	6 weeks

Collaborators and Investigators

• Sponsor: University of the State of Santa Catarina
• Collaborators: Fundação de Amparo à Pesquisa e Inovação do Estado de Santa Catarina

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): April 1, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Fascia; Long COVID; Manual Therapy
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: Fascial Tissue Response

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No