Radiofrequency 448khz in Patients Post Covid 19 With Respiratory Sequelae.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Spirometry
Study Overview
Brief Summary
The sequelae that occur in post-COVID-19 patients are multiple and, at a therapeutic level, these represent a new challenge within the general context of the pandemic that the world is suffering.
The virus has managed to end thousands of lives today and many other cases are being charged as directly responsible for a multiplicity of multisystem damages that need to be diagnosed and treated. Among the most relevant, are those that can affect to respiratory levels in patients without previous pahologies, and in patients at risk who already had a pathology prior to infection.
On the other hand, signs and symptoms have been observed characteristic in the organ systems described above in post-contagion patients, directly associated with sequelae SARV-CoV2. The radiofrequency (RF) of electromagnetic waves represents a technology of proven efficacy and safety in multiple fields of both human and veterinary medicine.
These include neurological pathologies, respiratory disease and very especially those that affect the locomotor system. In therapeutics there are different RF modalities depending on the modality, polarity, type of signal and frequency, which in turn translate into different therapeutic profiles, clinical indications, efficacy and safety.
Among the RF technologies most used today and that have a greater scientific background, is the one known as Resistive Capacitive Monopolar RadioFrequency at 448 kHz (INDIBA®) (RFMCR). This study aims to assess the efficacy and safety of RFMCR in the treatment of respiratory sequelae in patients presenting this type of pathologies that appear after contagion by COVID-19. Through this non-invasive technique, the investigators want to show that RF can help the physical rehabilitation of these patients through metabolic stimulation, increased vascularization and oxygenation of directly affected tissues, effects of deep hyperthermia generated by the interaction of the current with the treated biological substrate, as well as the activationof tissue regeneration, the result of subthermal action. It is thus intended to improve signs such as lung capacity, dyspnea, neuropathies and global muscle capacity, which are essential for the recovery of the post-COVID-19 patients.
The hypothesis of this study is that current post-COVID-19 treatments can be significantly improved in order to prevent complications and ensure the patients' well-being.
Detailed Description
The new post-pandemic era has left sequelae in patients who presented the signs and symptoms of SARS-CoV-2 and subsequently faced a positive for COVID-19. Such sequelae will be evident at various systemic levels of the affected patienta in the short, medium and long term future. One of these levels is respiratory complications and injuries that have been documented throughout all scientific research since the beginning of passive infections worldwide.
SARS-CoV-2 is transmitted by penetrating the respiratory route (mostly), by fluid contact, and to a lesser extent, through the ocular pathway. In the field of neurology system, different forms of RF, nerve infiltrations, lymph node injuries, plantar fasciitis, spinal (peripheral) nerve disorders, etc. have been documented.
If the investigators focus on one of the most prevalent symptoms (those that affect the respiratory system), the bibliography that endorses that the RFMCR could improve has been referenced.
The aim of this study is to evaluate the efficacy of combined manual therapy and 448 kHz radiofrequency treatment in the recovery of lung capacity in patients with post-COVID-19 sequelae. The work proposed here aims to demonstrate the advantages of establishing RF as an excellent treatment for post-COVID-19 sequelae, due to its ability to reinforce immune action, modulate the inflammatory response and activate cellular and tissue regeneration.
The specific objectives of this research work are:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •have passed covid 19
- •have respiratory sequelae after covid 19 during more than a month
- •have dyspnea, cough or fatigue
Exclusion Criteria
- •be pregnant
- •have pacemaker
- •have or had passes thrombosis
- •have a respiratory disease before covid
Arms & Interventions
Placebo group
The radiofrequency is turn off during the treatment
Intervention: Placebo (Other)
Conventional Group
Manual tecniques are applied to improve lung capacity
Intervention: Manual tecniques (Other)
Experimental Group
Manual tecniques and radiofrequency are applied to improve lung capacity
Intervention: Radiofrequency and manual tecniques (Other)
Outcomes
Primary Outcomes
Spirometry
Time Frame: 3 months
spirometry tests were performed in the same manner: the patient was seated with their feet flat on the floor and a nose clip was placed on the patient and they were asked to take two normal breaths, and on the third, to take a maximum inhalation and a maximum exhalation. We obteined the following parameters: FVC (Forced Vital Capacity), FEV1 (Forced Expiratory Volume in 1 Second), FVC/FEV1 (Ratio of FVC to volume expired in 1 second), PEF (Peak Expiratory Flow), PEFT (Peak Expiratory Flow Time), FEF50% (Forced expiratory flow at 50% of expiration), FEF25% - FEF75% (Forced expiratory flow between 25% and 75% of expiration), FEF50%/FIF50 (Ratio of forced expiratory flow at 50% of expiration to forced inspiratory flow at 50% of inspiration) and FEV1/FEV0.5 (Ratio of forced expiratory volume in 1 second to forced expiratory volume in the first 0.5 s
Secondary Outcomes
- Sadoul Dyspnea Scale(3 months)
- Leiscester Test(3 months)
- Chest measurements(3 months)
Investigators
GEMA LEÓN BRAVO
Gema León Bravo
Clinica Gema Leon