Efficacy of Non-invasive Neuromodulation Treatments for COVID-19 Sequelae
NCT Number: NCT06544395
Acronym: COVID-19
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Covid-19 Recurrent
Interventions: DEVICE: Non invasive neuromodulation therapy|OTHER: Manual therapy|DEVICE: Placebo with non invasive neuromodulation
Sponsor: Clinica Gema Leon
Sex: ALL
Age: ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-10-30
Locations: Gema León Physiotherapy and Rehabilitation Clinic, Córdoba, Andalucía, 14011, Spain

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.

Primary Outcome Measures: ad hoc patient survey, survey of patients about conditions diagnosed during the illness and those they suffer from after infection that are directly related to abnormalities to be assessed., one month|sex, age, vaccination and number of months with symptoms, Nominal variables such as sex, age, vaccination and number of months with symptoms, one month|Number of participants with musculoskeletal, respiratory and neurological sequelae of taste and smell after COVID-19, three months
Secondary Outcome Measures: SDOQ-NS questionnaire for social impairments due to loss of smell, Assess the quality of life impairments of patients with olfactory dysfunction. In a scale of 0 to 3, with higher scores reflecting better olfactory-specific, two months|SF12 Quality of Life Questionnaire, Assesses the impact of health on an individual's everyday life. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health., two months|Brief Smell Identification Test: Assessment of smell., Assesses the ability to recognize familiar odors. A 12-item questionnaire. For each item, a microcapsule containing a familiar odor is scratched with a pencil and placed under the participant's nose.

The total score is the number of odors that are correctly recognized. Missing responses are assigned a partial score of 0.25. If more than 2 responses are missing, the entire test is treated as missing., two months|EuroQoL 5-D scale (validated translation into Spanish) for quality of life., Quality of life related to health.

Questionaire with two parts:

1. Descriptive system (5 items). Minimum value: 1 (absence of dificulties). Maximum value: 3 (plenty of difficulties). Optimal value: 1.
2. Visual analogical scale (EVA). Minimum value: 0 (worst imaginable state of health). Maximum value: 100 (best imaginable state of health). Optimal value: 100., two months|upper limb functional index, It is used to evaluate functional impairment in people with upper extremity musculoskeletal dysfunction. 25 questions assessing the level of difficulty in performing activities of daily living using your upper extremities, including household and work activities, hobbies, lifting a bag of food, washing your scalp, pushing on your hands, driving, etc. Patients respond to each item by circling the number that best describes their level of difficulty., two months|lower limb functional index, Valid patient-rated outcome measure to measure lower extremity function. The lower the score the greater the disability. The minimal detectable change is 9 scale points., two months|Visual analogue scale (VAS), for pain assessment, Intensity of pain. Minimum value: 0 (absence of pain). Maximum value: 10 (unbearable pain). Optimal value: 0., two months|Sensory assessment for pain and light touch, The sensory exam involves evaluation of pain and light touch. Test pain using a sharp object. At minimum, test the shoulders, arms and legs, comparing side to side and proximal to distal areas. In any area where the patient complains of sensory loss or hypersensitivity, more detailed testing may be required.

For light touch, uses your fingertips or a wisp of cotton, lightly stroke the skin and determine if the patient feels this symmetrically in all areas tested. At minimum, test the shoulders, arms and legs, comparing side to side and proximal to distal areas., two months|Sadoul's dyspnea rating scale., Respiratory evaluation. Minimum value: 0 (absence of dyspnea). Maximum value: 5 (dyspnea occurs with minimal efforts). Optimal value: 0., two months|measurement of lung function with spirometry and lung volume testing, measurement of lung function with spirometry and lung volume testing (measurement of maximum inspiratory and expiratory pressures (Pimax and Pemax, respectively), three months