Radiofrequency Intervention in Musculoskeletal Pathologies Post COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Joint range of motion was measured
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 multisystem damages that need to be diagnosed and treated. Among the most relevant, are those that can affect to levels musculoskeletal in patients without previous pathologies, 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 radiofrequency (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®). This study aims to assess the efficacy and safety of RFMCR in the treatment of 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 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 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 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18 and
- •Patients with a positive diagnosis of COVID-
- •Patients with post-COVID-19 sequelae with elbow musculoskeletal diseases.
- •Patients who signed the informed consent.
排除标准
- •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.
结局指标
主要结局
Joint range of motion was measured
时间窗: 3 months
Measurements were taken using a goniometer of at least two joint movement axes in each casMeasurements were taken using a goniometer of at least two joint movement axes in each case
A muscle assessment was performed.
时间窗: 3 months
Strength measurements were taken using a dynamometer. The peak torque during a 5-second concentric contraction was measured. This contraction was repeated a total of three times, with the average of the three measurements taken as the final result.
次要结局
- Visual Analogue Scale for pain (VAS)(3 months)
- Patient independence (Katz Index)(3 months)
- Upper Limb Functional Index questionnaire(3 months)
- Lower Extremity Functional Scale for the lower limb.(3 months)
研究者
GEMA LEÓN BRAVO
Investigador Principal
Clinica Gema Leon