Radiofrequency Intervention in Neurological Pathologies Post COVID-19

NCT04920890 | Completed

• 1 other identifier: ART-GLB-RF-COVID
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 multi-system damages that need to be diagnosed and treated. Among the most relevant, are those that can affect to neurological 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 radio frequency (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, 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 Radio Frequency at 448 kHz (INDIBA®) (RFMCR). This study aims to assess the efficacy and safety of RFMCR in the treatment of neurological 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 activation of 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.

Conditions

Covid19; Neurological Injury; Olfactory Disorder; Gustatory Agnosia

Keywords

COVID-19; Multisystemic damage; Olfactory disorder; Gustatory agnosia; Radiofrequency Therapy

Outcome Measures

Primary Outcomes (2)

• Brief Smell Identification Test

  A score of 0 is given (does not identify) or 1 (identifies odor but not the same as before) or 2 (identifies). Optimun value: 24

  3 months

• Validated Taste assesment from Luigi Angelo Vaira y cols.

  Taste scores ranged from 0 to 4, allowing patients to be classified into four categories: normal (score 4), mild hypogeusia (score 3), moderate hypogeusia (score 2), severe hypogeusia (score 1), and ageusia (score 0). Optimal value: 16

  3 months

Secondary Outcomes (1)

• Questionnaire of olfactory disturbances (sQOD-NS)

  3 months

Study Arms (1)

Patients receiving radiofrequency treatment with manual therapy.

EXPERIMENTAL

Patients without previous pathology of any kind who have passed the Covid19 and have olfactory and gustatory sequelae; who will receive radiofrequency treatment with manual therapy.

Device: Radiofrequency therapy with manual therapy

Interventions

Radiofrequency therapy with manual therapy DEVICE

Monopolar Capacitive Resistive Radio Frequency at 448 kHz (INDIBA®) (RFMCR) with manual therapy.

Also known as: INDIBA

Patients receiving radiofrequency treatment with manual therapy.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have passed the covid-19 disease without any previos pathology.
• Have olfactory and gustatory disorders one month later of COVID-19

You may not qualify if:

• Have passed the covid-19 disease with previous pathology, or not having passed the covid-19 disease.
• Have contraindications for the application of Indiba, such as pregnancy, pacemaker or thrombophlebitis

Sponsors & Collaborators

• Clinica Gema Leon: lead

Study Sites (1)

Gema León Physiotherapy and Rehabilitation Clinic

Córdoba, Andalusia, 14011, Spain

Location

MeSH Terms

Conditions

COVID-19; Trauma, Nervous System; Agnosia

Interventions

Radiofrequency Therapy; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Nervous System Diseases; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gema León Bravo, Fisioterapia

  Gema León Physiotherapy and Rehabilitation Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador principal

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 10, 2021
• Study Start: June 16, 2021
• Primary Completion: June 21, 2022
• Study Completion: July 20, 2022
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)