Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920890
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2021-05-26
Brief Title:
Radiofrequency Intervention in Post COVID-19 Patients
Sponsor:
Clinica Gema Leon
Organization:
Clinica Gema Leon
Study Overview
Official Title:
Radiofrequency Intervention in Neurological Pneumological and Musculoskeletal Pathologies Post COVID-19
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 respiratory and musculoskeletal 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 and pneumological 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 respiratory and musculoskeletal 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
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 respiratory and musculoskeletal 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 and pneumological 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 respiratory and musculoskeletal 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
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 neurological respiratory and 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 pulmonology and the musculoskeletal 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
In 1992 Martínez Rubio and Bordas described how from the first treatment session 60 of asthmatic patients treated n 52 improved significantly both in terms of bronchospasm and dyspnea In general 5 to 10 sessions were necessary to improve symptoms in more than 75 of patients In 2020 Bito et al published how the use of this technology significantly increases chest wall motility in older women 746 54 years on average n 28 These symptomatic effects can be correlated with the findings of Tashiro et al which proved that 15 minutes of treatment at the epigastric level significantly increased p 0016 the levels of total hemoglobin Hb and oxy-Hb and how this significant increase was maintained at least up to 30 minutes after the end of the treatment at which time measurement was interrupted These findings reinforce those described by Bito et al and those of Yokata et al
No less important are the proven effects of hyperthermia in strengthening the immune system both in healthy patients prevention and in patients with infectious diseases
The aim of this study is to assess the potential benefits of RFMCR in patients with neurological respiratory andor 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
1 To demonstrate the efficacy of RFMCR as a therapy in neurological respiratory and musculoskeletal pathologies derived from the sequelae of COVID-19
2 To evidence and document the effects generated by the treatment with RFMCR in such systems
3 To estimate the level of benefit from RF in each of the different systems treated and define the benefitrisk ratio
4 To present and validate the therapy for the injuries under study that show significant improvements
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 32018 Law on the protection of personal data LOPDGDD article 5 Article 51 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 SA 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 98 patients for each type of pathology neurological respiratory and musculoskeletal who confirmed a positive test for COVID-19 Thus the entire population was 294 patients 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 TTHREE GROUPS Group A or placebo of 33 participants for each pathology modality evaluated and administered false treatment with the machine turned offThis group will be divided into 3 subgroups Placebo with neurological A1 respiratory A2 andor musculoskeletal pathologies A3 acquired after COVID-19 group B or group of treatment with RF and manual therapy This group will be divided into 3 subgroups of 34 participants each Group B1 Neurological Pathologies after COVID-19 and positive in COVID-19 with RF treatment y manual therapy Group B2 Respiratory Pathologies after COVID-19 and positive in COVID-19 with RF treatment and manual therapy and Group B3 Musculoskeletal Pathologies after COVID-19 and positive in COVID-19 with RF treatment and manual therapy Finally Group C of 31 participants each Group C1 Neurological Pathologies after COVID-19 and positive in COVID-19 with manual therapy Group C2 Respiratory Pathologies after COVID-19 and positive in COVID-19 with manual therapy and Group C3 Musculoskeletal Pathologies after COVID-19 and positive in COVID-19 with manual therapy
Thus we compare the therapies of groups A1 B1 and C1 of Neurological Pathologies Then we compare the therapies of groups A2 B2 and C2 of Respiratory Pathologies
And Finally we compare the therapies of groups A3 B3 and C3 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 98 participants each 294 in total
Group A Control without pathologies neurological respiratory andor musculoskeletal previous and positive confirmed in test carried out without protocol of RF wave treatment or Placebo with Neurological Pathologies after COVID-19 or A1 Respiratory Pathologies after COVID-19 or A2 and Musculoskeletal Pathologies after COVID-19 or A3 acquired after COVID-19
Group B or group of treatment with RF and manual therapy Group B1 Neurological Pathologies after COVID-19 Group B2 Respiratory Pathologies after COVID-19 Group B3 Musculoskeletal Pathologies after COVID-19 these last three subgroups being group B of treatment with RFMCR INDIBA Activ and manual therapy
Group C or group of treatment with manual therapy only Group C1 Neurological Pathologies after COVID-19 and positive in COVID-19 with manual therapy Group C2 Respiratory Pathologies after COVID-19 and positive in COVID-19 with manual therapy and Group C3 Musculoskeletal Pathologies after COVID-19 and positive in COVID-19 with manual therapy
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 Ashworth Scale modified for spasticity reflectivity measurement with the Wartenberg Scale for bone tendon reflexes ROTs examination of sensitivity from evaluation of dermatomes measurement of lung function with spirometry tests for respiratory muscle function measurement of inspiratory and expiratory pressures maximum Pimax and Pemax respectively and Sadoul scale for dyspnea and measurement of costal excursion 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 005 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
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 pulmonology and the musculoskeletal 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
In 1992 Martínez Rubio and Bordas described how from the first treatment session 60 of asthmatic patients treated n 52 improved significantly both in terms of bronchospasm and dyspnea In general 5 to 10 sessions were necessary to improve symptoms in more than 75 of patients In 2020 Bito et al published how the use of this technology significantly increases chest wall motility in older women 746 54 years on average n 28 These symptomatic effects can be correlated with the findings of Tashiro et al which proved that 15 minutes of treatment at the epigastric level significantly increased p 0016 the levels of total hemoglobin Hb and oxy-Hb and how this significant increase was maintained at least up to 30 minutes after the end of the treatment at which time measurement was interrupted These findings reinforce those described by Bito et al and those of Yokata et al
No less important are the proven effects of hyperthermia in strengthening the immune system both in healthy patients prevention and in patients with infectious diseases
The aim of this study is to assess the potential benefits of RFMCR in patients with neurological respiratory andor 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
1 To demonstrate the efficacy of RFMCR as a therapy in neurological respiratory and musculoskeletal pathologies derived from the sequelae of COVID-19
2 To evidence and document the effects generated by the treatment with RFMCR in such systems
3 To estimate the level of benefit from RF in each of the different systems treated and define the benefitrisk ratio
4 To present and validate the therapy for the injuries under study that show significant improvements
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 32018 Law on the protection of personal data LOPDGDD article 5 Article 51 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 SA 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 98 patients for each type of pathology neurological respiratory and musculoskeletal who confirmed a positive test for COVID-19 Thus the entire population was 294 patients 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 TTHREE GROUPS Group A or placebo of 33 participants for each pathology modality evaluated and administered false treatment with the machine turned offThis group will be divided into 3 subgroups Placebo with neurological A1 respiratory A2 andor musculoskeletal pathologies A3 acquired after COVID-19 group B or group of treatment with RF and manual therapy This group will be divided into 3 subgroups of 34 participants each Group B1 Neurological Pathologies after COVID-19 and positive in COVID-19 with RF treatment y manual therapy Group B2 Respiratory Pathologies after COVID-19 and positive in COVID-19 with RF treatment and manual therapy and Group B3 Musculoskeletal Pathologies after COVID-19 and positive in COVID-19 with RF treatment and manual therapy Finally Group C of 31 participants each Group C1 Neurological Pathologies after COVID-19 and positive in COVID-19 with manual therapy Group C2 Respiratory Pathologies after COVID-19 and positive in COVID-19 with manual therapy and Group C3 Musculoskeletal Pathologies after COVID-19 and positive in COVID-19 with manual therapy
Thus we compare the therapies of groups A1 B1 and C1 of Neurological Pathologies Then we compare the therapies of groups A2 B2 and C2 of Respiratory Pathologies
And Finally we compare the therapies of groups A3 B3 and C3 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 98 participants each 294 in total
Group A Control without pathologies neurological respiratory andor musculoskeletal previous and positive confirmed in test carried out without protocol of RF wave treatment or Placebo with Neurological Pathologies after COVID-19 or A1 Respiratory Pathologies after COVID-19 or A2 and Musculoskeletal Pathologies after COVID-19 or A3 acquired after COVID-19
Group B or group of treatment with RF and manual therapy Group B1 Neurological Pathologies after COVID-19 Group B2 Respiratory Pathologies after COVID-19 Group B3 Musculoskeletal Pathologies after COVID-19 these last three subgroups being group B of treatment with RFMCR INDIBA Activ and manual therapy
Group C or group of treatment with manual therapy only Group C1 Neurological Pathologies after COVID-19 and positive in COVID-19 with manual therapy Group C2 Respiratory Pathologies after COVID-19 and positive in COVID-19 with manual therapy and Group C3 Musculoskeletal Pathologies after COVID-19 and positive in COVID-19 with manual therapy
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 Ashworth Scale modified for spasticity reflectivity measurement with the Wartenberg Scale for bone tendon reflexes ROTs examination of sensitivity from evaluation of dermatomes measurement of lung function with spirometry tests for respiratory muscle function measurement of inspiratory and expiratory pressures maximum Pimax and Pemax respectively and Sadoul scale for dyspnea and measurement of costal excursion 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None