Effectiveness of Manual Therapy Combined With INDIBA Radiofrequency in the Recovery of Persistent Olfactory and Gustatory Alterations Post-COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Brief Smell Identification Test
研究概览
简要总结
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.
详细描述
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 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 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 persistent anosmia and ageusia 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have passed the covid-19 disease without any previos pathology.
- •Have olfactory and gustatory disorders one month later of COVID-19
排除标准
- •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
结局指标
主要结局
Brief Smell Identification Test
时间窗: 3 months
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
Validated Taste assesment from Luigi Angelo Vaira y cols.
时间窗: 3 months
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
次要结局
- Questionnaire of olfactory disturbances (sQOD-NS)(3 months)
研究者
GEMA LEÓN BRAVO
Investigador principal
Clinica Gema Leon
