The sequelae that occur in post-COVID-19 patients are multiple and, at a therapeuticlevel, these represent a new challenge within the general context of the pandemic thatthe world is suffering.The virus has managed to end thousands of lives today and many other cases are beingcharged as directly responsible for a multiplicity of multisystem damages that need to bediagnosed and treated. Among the most relevant, are those that can affect to respiratorylevels in patients without previous pahologies, and in patients at risk who already had apathology prior to infection.On the other hand, signs and symptoms have been observed characteristic in the organsystems described above in post-contagion patients, directly associated with sequelaeSARV-CoV2. The radiofrequency (RF) of electromagnetic waves represents a technology ofproven efficacy and safety in multiple fields of both human and veterinary medicine.These include neurological pathologies, respiratory disease and very especially thosethat affect the locomotor system. In therapeutics there are different RF modalitiesdepending on the modality, polarity, type of signal and frequency, which in turntranslate 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 ofrespiratory sequelae in patients presenting this type of pathologies that appear aftercontagion by COVID-19. Through this non-invasive technique, the investigators want toshow that RF can help the physical rehabilitation of these patients through metabolicstimulation, increased vascularization and oxygenation of directly affected tissues,effects of deep hyperthermia generated by the interaction of the current with the treatedbiological substrate, as well as the activationof tissue regeneration, the result ofsubthermal 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 thepost-COVID-19 patients.The hypothesis of this study is that current post-COVID-19 treatments can besignificantly improved in order to prevent complications and ensure the patients'well-being.
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:
1. To analyze the evolution of lung capacity using an espirometry in patients treated
with the combined protocol.
2. To evaluate the improvement in dysnea and tough 3. To determine the impact of
treatment on quality of life. 4. To examine the tolerance, safety and possible side
effects of the combined treatment in post-COVID-19 patients. REGULATIONS
1. This clinical study will be carried out in accordance with the protocol, the
principles established in the current revised version of the Declaration of Helsinki
(Fortaleza, 2013) and in accordance with the applicable regulatory requirements.
2. The researcher is aware, when signing the protocol, of the obligation to adhere to
the instructions and procedures described in it, and will ensure that the
established provisions are strictly adhered to.
3. The study will not begin until the approval of the Research Ethics Committee has
been obtained.
4. The principal investigator is responsible for ensuring that this protocol, the
informed consent document, and any other information that is presented or
facilitated to the possible subjects is reviewed and approved by the CEI. The
Researcher agrees to allow direct access to the REC to all relevant documents.
INFORMED CONSENT.
5. In this case, patients must give their consent prior to being included in the study.
The content and the procedure for obtaining it must be in accordance with all
applicable legal requirements.
6. The investigator is responsible for obtaining the written informed consent of each
patient participating in this study, after having explained in an understandable
way, the nature, objectives, methods, expected benefits and possible risks of the
study. The investigator must also explain to them that patients are completely free
to refuse to participate in the study or to withdraw from it at any time, for
whatever reason.
7. The study patients will give their consent, signing the corresponding model. For
this purpose, each informed consent must be signed by both the investigator and the
patient.
CONFIDENTIALITY.
8. All information related to the study is considered confidential in compliance with
the confidentiality and custody of the data collected, in accordance with the 3/2018
Law on the protection of personal data (LOPDGDD), (article 5). Article 5.1 .f) of
the RGPD states that personal data will be treated in such a way as to guarantee
confidentiality and integrity
9. In order to guarantee the confidentiality of the study data, only the main
researcher and her team of collaborators will have access to it, the CEI and the
pertinent health authorities.
FINANCING
1. The financing is assumed by the Gema León Physiotherapy and Rehabilitation Clinic.
There is no direct economic consideration for this, although there is a dedication
of time and work by the team of physiotherapists (social security, payroll, personal
income tax, etc.) that is not economically remunerated and is assumed or absorbed
this way. In addition, the RFMCR technology (equipment and accessories) will be
provided by the company INDIBA S.A., through a temporary assignment without any
financial compensation either from the Gema León Physiotherapy Clinic, or from any
patient. The treatment of these is completely free for them.
2. The patient must travel to the clinic facilities and it is the researcher who will
be responsible for the treatment in it.
3. No difficulties are foreseen in its performance since it will be carried out using a
schedule adapted to the patient that allows the study to be monitored.
It is intended to carry out a longitudinal study with the participation of 96 patients
with lung capacity alterations, who confirmed a positive test for COVID-19. The sample
size for our study is large enough to detect a clinically important difference in the
primary outcome (s). For this, the investigators reviewed references at the bibliographic
level, in which paired studies obtained a statistically significant value, being able to
support our study.
If the sample size was insufficient but statistically significant, the investigators
would resort to expanding the sample.
The participants were divided into three groups:
- Group 1 or Placebo: the radiofrequency is turn off during the treatment
- Group 2 or conventional: Respiratory manual tecniques are carried out during the
treatments to improve lung capacity
- Group 3 or experimental: Radiofrequency 448kz and manual tecniques are applied. They
will be evaluated at the beginning, a second evaluation after 3 weeks and a third
final control after 12 sessions. A fourth evaluation will be carried out after the
last and final evaluation, 6 weeks after finishing the treatment.
Each of the participants will be informed of the study, the objective, its possible
benefits and the side effects that could arise. A) Therefore, each patient must give
their free and confirmed consent through signature. Among the items in the methodology,
the following stand out:
Primary outcome: Spirometry was performed at the beginning of the first, sixth, and
twelfth sessions, and one and a half months after completing treatment. All 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 outcome: The Sadoul Dyspnea Scale is internationally validated to evaluate the
feeling of the patient´sdyspnea and has a 6-grade classification: Grade 0 (No dyspnea),
Grade 1 (Dyspnea after significant exertion or climbing two flights of stairs), Grade 2
(Dyspnea when climbing one flight of stairs or with brisk walking on a slight incline),
Grade 3 (Dyspnea during brisk walking on level ground), Grade 4 (Dyspnea occurs with slow
walking), Grade 5 (Dyspnea with minimal exertion)
Tertiary outcome: Chest measuremnets. All chest measurements, were taken at the first and
last measurement sessions, following the same protocol. These measurements were taken
with the subject standing in a neutral position and at three different levels, using the
following reference points at each level: the axillary line, the tip of the xiphoid bone,
and the level of the tenth rib. In addition, three measurements were taken at each level
at maximum inspiration, maximum expiration, and neutral.
The therapeutic protocol will be executed in the facilities of the Gema León
Physiotherapy and Rehabilitation Clinic (Cordoba, Spain). Depending on the group of
treatments the protocol will consist in:
- Group 1 or Placebo: the radiofrequency is turn off during the treatment
- Group 2 or conventional: Respiratory manual tecniques are carried out during the
treatments to improve lung capacity,
- Group 3 or experimental: the same manual tecniques of the group 2 are applied while
we use the radiofrequency. We divide the treatment in 3 phases:
PHASE 1: With the patient in the supine position, treatment was performed along the
diaphragm for 10 minutes, of which 5 minutes were spent with the capacitive electrode and
the other 5 minutes with the resistive electrode. The plate was placed on the back at the
level of the diaphragm.
PHASE 2: The patient was placed in the lateral decubitus position on their right side and
3 minutes were spent with the capacitive electrode and 7 minutes with the resistive
electrode. The patient was asked to breathe costal-diaphragmatically throughout the
entire duration of the resistive electrode. The plate was placed on the right side, at
lung level.
PHASE 3: The same procedure was performed as in the second phase, only this time on the
contralateral side.
Such RF therapeutic protocol will be implemented by application with an INDIBA® Activ
device, whose function is to reduce inflammation, stimulate immunity and promote tissue
regeneration. This will consist of a 45-minute treatment. A total of 12 sessions will be
scheduled (two per week), and all processes will be documented from the beginning of
therapy (the resources used will be provided by INDIBA and the Gema León Physiotherapy
and Rehabilitation Clinic, whose supervision will be carried out by the direction of
both).
Another variables which they are gonna be take into account are sex, age, weight, height,
smoker, vaccination, number of days with symptoms and type of symptom.
The statistical analysis is based on variables of nominal type mostly, which are suitable
for the Chi square test with a significance value of 95% for the results (p <0.05).
However, if there are numerical data that must be compared between groups, the analysis
will be used for ANOVA test with the same significance value for the comparison between
results.
Other: Radiofrequency and manual tecniques
We apply manual tecniques while we use the radiofrequency, the treatment is divided into
3 phases:
- PHASE 1: With the patient in the supine position, treatment was performed along the
diaphragm for 10 minutes, of which 5 minutes were spent with the capacitive
electrode and the other 5 minutes with the resistive electrode. The plate was placed
on the back at the level of the diaphragm.
- PHASE 2: The patient was placed in the lateral decubitus position on their right
side and 3 minutes were spent with the capacitive electrode and 7 minutes with the
resistive electrode. The patient was asked to breathe costal-diaphragmatically
throughout the entire duration of the resistive electrode. The plate was placed on
the right side, at lung level.
- PHASE 3: The same procedure was performed as in the second phase, only this time on
the contralateral side, i.e., on the left side.
Other: Manual tecniques
Manual techniques are used to increase inspiratory capacity, working on the diaphragm and
rib cage to increase their mobility along with breathing exercises.
Other: Placebo
The radiofrequency is turn off
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
Clinica de Fisioterapia Gema Leon
Córdoba 2519240, Cordoba, Spain
Gema León Bravo, Fisioterapia, Principal Investigator
Gema León Physiotherapy and Rehabilitation Clinic