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

Clinica Gema Leon

Status: Not yet enrolling

Conditions: Covid-19 Recurrent

Treatments: Other: Manual therapy; Device: Non invasive neuromodulation therapy; Device: Placebo with non invasive neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06544395

NO INVASIV NEUROMOD COVID-19

NO INVASIVE NEUROM-COVID-19 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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104 participants in 3 patient groups, including a placebo group

Patients receiving non invasive neuromodulation treatment.

Experimental group

Description:

Patients without previous pathology of any kind who have passed the Covid19 and have respiratory, neurological or musculoskeletal sequelae; who will receive non invasive neuromodulation treatment.

Treatment:

Device: Non invasive neuromodulation therapy

Patients receiving traditional treatment.

Active Comparator group

Description:

Patients receiving only traditional therapy. Patients without previous pathology of any kind who have passed the Covid19 and have respiratory, neurological or musculoskeletal sequelae; who will receive treatment of traditional therapy.

Treatment:

Other: Manual therapy

Patients receiving placebo treatment.

Placebo Comparator group

Description:

Patients receiving placebo. Patients without previous pathology of any kind who have passed the Covid19 and have respiratory, neurological or musculoskeletal sequelae; to those who will be administered placebo (device off, without emitting).

Treatment:

Device: Placebo with non invasive neuromodulation