Efficacy of Non-invasive Neuromodulation Treatments for COVID-19 Sequelae

Официальное название

Efficacy of Non-invasive Neuromodulation Treatments for Post-COVID-19 Sequelae in Patients With Musculoskeletal, Respiratory and Neurological Conditions Due to Impaired Taste and Smell.

Обзор

The goal of this clinical trial is to demonstrate the effectiveness of non-invasive Neuromodulation as a therapy in neurological, respiratory and musculoskeletal pathologies derived from the consequences of Covid-19. It will also estimate the impact of non-invasive neuromodulation treatment on the functionality and quality of life of patients with COVID-19 sequelae.The main question it aim to answer is: \- Is non-invasive neuromodulation effective as a therapy in neurological, respiratory and musculoskeletal pathologies derived from the consequences of Covid-19. Researchers will compare non-invasive neuromodulation to a placebo (treatment with the machine turned off). Participants will: * Be evaluated before starting treatment. * Be evaluated 3 weeks after. * Be evaluated at 5 weeks, or 15 sessions or completion of treatment. * Be evaluated 6 weeks after finishing the treatment or 11 weeks after starting treatment.

Подробное описание

The waves of Sars-Cov-2 disease continue to be continuous and we are increasingly aware of the consequences it causes both in the respiratory system, musculoskeletal system and in the central and peripheral nervous system.

Likewise, non-invasive neuromodulation acts with a pump of ions, generating endogenous stimuli that modulate the central nervous system.

The aim of this clinical trial is to demonstrate the effectiveness of non-invasive Neuromodulation as a therapy in neurological, respiratory and musculoskeletal pathologies derived from the consequences of Covid-19.

To carry out this study, pain was measured with the visual analogue scale. It was also measured the joint amplitude, a muscle assessment with the help of a strength dynamometer, the patient's independence with the Katz index and the functionality of the lower or upper limbs, depending on the affected joint.

Вмешательства

• Устройство Non invasive neuromodulation therapy
  In the 4 studies, the intervention consisted of 15 sessions spread over 5 weeks. Each intervention lasted 60 minutes. The intensity will be programmed in all sessions at Low, following the Arndt-Schulz law. The treatment was distributed in 3 phases: phase 1 of preparation, phase 2 to reduce fatigue and phase 3 to enhance autonomic improvement.
• Другое Manual therapy
  Common manual therapy administered for said pathology by traditional physiotherapy and therapeutic exercise.
• Устройство Placebo with non invasive neuromodulation
  In the 4 studies, the intervention consisted of 15 sessions spread over 5 weeks. Each intervention lasted 60 minutes. The treatment was carried out with the machine turned off.

Первичные конечные точки

• ad hoc patient survey [Срок оценки: one month]
• sex, age, vaccination and number of months with symptoms [Срок оценки: one month]
• Number of participants with musculoskeletal, respiratory and neurological sequelae of taste and smell after COVID-19 [Срок оценки: three months]

Вторичные конечные точки (10)

• SDOQ-NS questionnaire for social impairments due to loss of smell [Срок оценки: two months]
• SF12 Quality of Life Questionnaire [Срок оценки: two months]
• Brief Smell Identification Test: Assessment of smell. [Срок оценки: two months]
• EuroQoL 5-D scale (validated translation into Spanish) for quality of life. [Срок оценки: two months]
• upper limb functional index [Срок оценки: two months]
• lower limb functional index [Срок оценки: two months]
• Visual analogue scale (VAS), for pain assessment [Срок оценки: two months]
• Sensory assessment for pain and light touch [Срок оценки: two months]
• Sadoul's dyspnea rating scale. [Срок оценки: two months]
• measurement of lung function with spirometry and lung volume testing [Срок оценки: three months]

Критерии участия

Критерии включения

• Patients between the ages of 18 and 60.
• Patients with a positive diagnosis of COVID-19.
• Patients with post-COVID-19 sequelae with musculoskeletal, respiratory or neurological symptoms due to taste or smell lasting at least 30 days, with no history of respiratory and/or neurological and/or musculoskeletal diseases.
• Patients who signed the informed consent.

Критерии исключения

• Patients aged before 18 years and after 60 years.
• Healthy people with no history of neurological, neurological and/or respiratory and/or musculoskeletal diseases
• Patients with secondary diseases that could directly affect the systems to be evaluated who were not diagnosed positive for COVID-19.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Gema León Physiotherapy and Rehabilitation Clinic — Córdoba

Идентификаторы

NCT: NCT06544395 · NO INVASIV NEUROMOD COVID-19 · NO INVASIVE NEUROM-COVID-19

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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