Efficacy of Non-invasive Neuromodulation Treatments for COVID-19 Sequelae
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non invasive neuromodulation therapy, Manual therapy, Placebo with non invasive neuromodulation.
- Who it may be relevant to
- Registry conditions: Covid-19 Recurrent. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Device 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. - Other Manual therapy
Common manual therapy administered for said pathology by traditional physiotherapy and therapeutic exercise. - Device 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.
Primary outcome measures
- ad hoc patient survey [Time frame: one month]
- sex, age, vaccination and number of months with symptoms [Time frame: one month]
- Number of participants with musculoskeletal, respiratory and neurological sequelae of taste and smell after COVID-19 [Time frame: three months]
Secondary outcome measures (10)
- SDOQ-NS questionnaire for social impairments due to loss of smell [Time frame: two months]
- SF12 Quality of Life Questionnaire [Time frame: two months]
- Brief Smell Identification Test: Assessment of smell. [Time frame: two months]
- EuroQoL 5-D scale (validated translation into Spanish) for quality of life. [Time frame: two months]
- upper limb functional index [Time frame: two months]
- lower limb functional index [Time frame: two months]
- Visual analogue scale (VAS), for pain assessment [Time frame: two months]
- Sensory assessment for pain and light touch [Time frame: two months]
- Sadoul's dyspnea rating scale. [Time frame: two months]
- measurement of lung function with spirometry and lung volume testing [Time frame: three months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Gema León Physiotherapy and Rehabilitation Clinic — Córdoba
Identifiers
NCT: NCT06544395 · NO INVASIV NEUROMOD COVID-19 · NO INVASIVE NEUROM-COVID-19