Clinical trial NCT06544395: Efficacy of Non-invasive Neuromodulation Treatments for COVID-19 Sequelae
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Covid-19 Recurrent
Keywords: Covid-19
Non Invasive Neuromodulation
Smell
Lead sponsor: Clinica Gema Leon
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: ad hoc patient survey
timeFrame: one month
measure: sex, age, vaccination and number of months with symptoms
timeFrame: one month
measure: Number of participants with musculoskeletal, respiratory and neurological sequelae of taste and smell after COVID-19
timeFrame: three months
Secondary outcomes:
measure: SDOQ-NS questionnaire for social impairments due to loss of smell
timeFrame: two months
measure: SF12 Quality of Life Questionnaire
timeFrame: two months
measure: Brief Smell Identification Test: Assessment of smell.
timeFrame: two months
measure: EuroQoL 5-D scale (validated translation into Spanish) for quality of life.
timeFrame: two months
measure: upper limb functional index
timeFrame: two months
measure: lower limb functional index
timeFrame: two months
measure: Visual analogue scale (VAS), for pain assessment
timeFrame: two months
measure: Sensory assessment for pain and light touch
timeFrame: two months
measure: Sadoul's dyspnea rating scale.
timeFrame: two months
measure: measurement of lung function with spirometry and lung volume testing
timeFrame: three months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Gema León Physiotherapy and Rehabilitation Clinic
state: Andalucía
Study officials:
affiliation: Departamento de Enfermería, Farmacología y Fisioterapia de la Universidad de Córdoba
name: GEMA LEÓN BRAVO
role: PRINCIPAL_INVESTIGATOR
References: