Official Title
Radiofrequency Intervention in Musculoskeletal Pathologies Post COVID-19
Brief Summary

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 levelsmusculoskeletal in patients without previous pathologies, and in patients at risk whoalready had a pathology 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 and pneumological pathologies, and very especially those thataffect the locomotor system. In therapeutics there are different RF modalities dependingon the modality, polarity, type of signal and frequency, which in turn translate intodifferent 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 Radio Frequency at 448 kHz (INDIBA®).This study aims to assess the efficacy and safety of RFMCR in the treatment ofmusculoskeletal sequelae in patients presenting this type of pathologies that appearafter contagion by COVID-19. Through this non-invasive technique, the investigators wantto show 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 activation of tissue regeneration, the result ofsubthermal action. It is thus intended to improve signs such as global muscle capacity,which is essential for the recovery of the post-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.

Detailed Description

The new post-pandemic era has left sequelae in patients who presented the signs and
symptoms of SARV-CoV2 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 musculoskeletal complications and injuries that
have been documented throughout all scientific research since the beginning of massive
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 RF could improve has been
referenced.

The aim of this study is to assess the potential benefits of RF in patients with
musculoskeletal problems which started after SARV-CoV-2 infection. 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:

To demonstrate the efficacy of RF as a therapy in musculoskeletal pathologies derived
from the sequelae of COVID-19.

To evidence and document the effects generated by the treatment with RF in the
musculoskeletal system.

To estimate the level of benefit from RF in the musculoskeletal system treated and define
the benefit/risk ratio.

To present and validate the therapy for the injuries under study that show significant
improvements.

REGULATIONS

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.

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.

The study will not begin until the approval of the Research Ethics Committee has been
obtained.

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.

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.

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.

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.

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 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

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 RF 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.

The patient must travel to the clinic facilities and it is the researcher who will be
responsible for the treatment in it.

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 99 patients
with elbow musculoskeletal pathology, 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 division of the
sample is carried out at random within the established groups.

The patients will be divided into three groups: Group A or Placebo Group, which received
the treatment with the machine turned off. Radiofrequency 448 Hz was administered to the
affected area in two phases, depending on the electrode applied: 10 minutes of capacitive
electrode and 35 minutes of resistive electrode, both with the machine turned off. Group
B or Mixed Group, treatment with manual therapy and radiofrequency. Radiofrequency 448 Hz
was administered to the affected area in two phases, depending on the electrode applied:
5 minutes of capacitive electrode and 25 minutes of resistive electrode. In addition, a
specific joint physical therapy manual therapy treatment was also performed, in which
pumping techniques were performed after the radiofrequency treatment.Group C or Manual
Group, to which conventional manual therapy was applied for each case. Articulatory
pumping techniques were applied towards the painful position with the aim of reducing it.

Thus we compare the therapies of groups A, B and C, of Musculoskeletal Pathologies.

All groups 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 data parameters: A series of questions will be asked to each of the patients
about the conditions diagnosed during the disease and those suffered after the infection
that are directly related to abnormalities to be assessed.

Secondary Data Parameters: The therapeutic protocol will be executed in the facilities of
the Gema León Physiotherapy and Rehabilitation Clinic (Cordoba, Spain). 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 30-minute treatment, composed by 5 minutes of
treatment with the capacitive electrode and 25 minutes of the resistive electrode. 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).

Dependent Variables: variables of nominal type such as sex, age, vaccination, number of
days with symptoms, type of symptom will be created. The patients will be grouped into 3
groups of 33 participants each (99 in total):

Group A or Placebo Group, which received the treatment with the machine turned off.
Radiofrequency 448 Hz was administered to the affected area in two phases, depending on
the electrode applied: 10 minutes of capacitive electrode and 35 minutes of resistive
electrode, both with the machine turned off.

Group B or Mixed Group, treatment with manual therapy and radiofrequency. Radiofrequency
448 Hz was administered to the affected area in two phases, depending on the electrode
applied: 5 minutes of capacitive electrode and 25 minutes of resistive electrode. In
addition, a specific joint physical therapy manual therapy treatment was also performed,
in which pumping techniques were performed after the radiofrequency treatment.

Group C or Manual Group, to which conventional manual therapy was applied for each case.
Articulatory pumping techniques were applied towards the painful position with the aim of
reducing it.

Independent Variables: In order to compare the variables between groups, different
methods of pain threshold and function of the mentioned systems will be used, such as:
Global Functionality Scale (GAF), Katz Index for Independence, Lawton and Brody Scale of
Basic Activities, Barthel index for disability, European Quality of Life 5-D
Questionnaire (EURO- QoL 5-D) for quality of life, Tinetti test for gait and balance,
joint amplitude scale measured with the goniometer (goniometry), strength muscle
dynamometer (Dynamometry), pain index (Visual Analogue Scale (VAS), reflectivity
measurement with the Wartenberg Scale for bone tendon reflexes (ROTs), examination of
sensitivity from evaluation of dermatomes. 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.

Completed
COVID19
Musculoskeletal Injury

Other: Radiofrequency 448khz with manual therapy

The intervention in consisted of a total of 12 sessions (twice a week) of treatment. The
set duration for each session was 45 minutes, except for those sessions where variable
measurements were required, which lasted 60 minutes. Radiofrequency 448 Hz was
administered to the affected area in two phases, depending on the electrode applied: 5
minutes of capacitive electrode and 25 minutes of resistive electrode. In addition, a
specific joint physical therapy manual therapy treatment was also performed, in which
pumping techniques were performed after the radiofrequency treatment.

Other: Turn off radiofrequency 448khz

Radiofrequency 448 Hz was administered to the affected area in two phases, depending on
the electrode applied: 10 minutes of capacitive electrode and 35 minutes of resistive
electrode, both with the machine turned off.

Other: Manual therapy

Articulatory pumping techniques were applied towards the painful position with the aim of
reducing it.

Eligibility Criteria

Inclusion Criteria:

- Patients between the ages of 18 and 60.

- Patients with a positive diagnosis of COVID-19.

- Patients with post-COVID-19 sequelae with elbow musculoskeletal diseases.

- Patients who signed the informed consent.

Exclusion Criteria:

- Patients aged before 18 years and after 60 years.

- Healthy people with no history of elbow musculoskeletal diseases

- Patients with secondary diseases that could directly affect the systems to be
evaluated who were not diagnosed positive for COVID-19.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
Spain
Locations

Gema León Physiotherapy and Rehabilitation Clinic
Córdoba, Andalucía, Spain

Gema Leon Bravo, Principal Investigator
Departamento de Enfermería, Farmacología y Fisioterapia de la Universidad de Córdoba

Clinica Gema Leon
NCT Number
Keywords
Covid-19
MeSH Terms
COVID-19