COVID-19NCT06348186
Fascial Tissue Response to Manual Therapy: Implications in Long COVID-19
A study testing Guidebook and Guidebook and Myofascial Reorganization® (RMF). in people with COVID-19, run by University of the State of Santa Catarina at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Guidebook and Guidebook and Myofascial Reorganization® (RMF).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2024to 31 Aug 2025
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants diagnosed with long COVID, of both sexes, aged between 20 and 80 years, from the community, outpatient clinics and hospitals.
Who cannot join
- Participants with suspected deep vein thrombosis; Participants with neurological disorders.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Santa Catarina State University
Florianópolis, Santa Catarina, 88.035-001
Larissa Sinhorim
About this study
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Guidebook, Guidebook and Myofascial Reorganization® (RMF).
- Keywords
- Long COVID, Manual Therapy, Fascia, Rehabilitation
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuidebookOther
Folder that will be given to the participant to carry out 5 minutes of intervention daily
Guidebook and Myofascial Reorganization® (RMF).Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Guidebook | Other | Not described Receives: Other: Guidebook |
| Guidebook and Myofascial Reorganization® (RMF). | Experimental | Not described Receives: Other: Guidebook and Myofascial Reorganization® (RMF). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Biomechanical and tissue viscoelastic properties
Will be evaluated by MyotonPro (MytonPro, Myoton Ltd.s., Tartu, Estonia)
Measured: 6 weeks
Secondary outcomes (4)
Work capacity
Will be assessed by the "Work Limitations Questionnaire, WLQ-25" translated and validated for the Brazilian population by Soárez et al (2007).
Measured: 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.
Measured: 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).
Measured: 6 weeks
Balance
Will be assessed using the Neurocom Balance Platform (VRS Sport) and its NeuroCom®Balance Manager program (Neurocom International, Inc, Clackamas, OR).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Feb 2024
- Primary completion1 Apr 2024
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Participants are randomly assigned to one of two or groups, typically an intervention group (fascia-focused manual therapy) and a control group. Participants are randomly allocated. Participants and outcomes assessor are blinded.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa e Inovação do Estado de Santa Catarina
- Responsible party
- Principal investigator, Gilmar Moraes Santos, PT, University of the State of Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348186
- Sponsor's protocol ID
- Fascial Tissue Response
- Status last verified
- May 2024
- First submitted
- 3 Apr 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascial Tissue Response to Manual Therapy: Implications in Long COVID-19
- ClinicalTrials.gov ID
- NCT06348186
- Acronym / sponsor ID
- Fascial Tissue Response
- Conditions
- COVID-19
- Keywords
- Long COVID, Manual Therapy, Fascia, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa e Inovação do Estado de Santa Catarina
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 4 Apr 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two or groups, typically an intervention group (fascia-focused manual therapy) and a control group. Participants are randomly allocated. Participants and outcomes assessor are blinded.
| Arm | Type | Receives |
|---|---|---|
| Guidebook | Other | Other: Guidebook |
| Guidebook and Myofascial Reorganization® (RMF). | Experimental | Other: Guidebook and Myofascial Reorganization® (RMF). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants diagnosed with long COVID, of both sexes, aged between 20 and 80 years, from the community, outpatient clinics and hospitals.
Key exclusion criteria (1 listed)
- Participants with suspected deep vein thrombosis; Participants with neurological disorders.
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 |
|---|---|---|
| GuidebookFolder that will be given to the participant to carry out 5 minutes of intervention daily | Other | Guidebook |
| 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. | Other | Guidebook and Myofascial Reorganization® (RMF). |
Primary outcome
Functioning and disability
Time frame: 6 weeks
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).
Biomechanical and tissue viscoelastic properties
Time frame: 6 weeks
Will be evaluated by MyotonPro (MytonPro, Myoton Ltd.s., Tartu, Estonia)
4 secondary outcomes
Work capacity
Time frame: 6 weeks
Level of Quality of life
Time frame: 6 weeks
Upper limb dysfunctions
Time frame: 6 weeks
Balance
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guidebook and Guidebook and Myofascial Reorganization® (RMF). in people with COVID-19, run by University of the State of Santa Catarina 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 20 Nov 2024. 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 Larissa Sinhorim (47984057340, larissasinhorim@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functioning and disability (time frame: 6 weeks). 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?
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 20 Nov 2024.