Physiotherapy for Persistent Function by Superficial Neuromodulation

Study Overview
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Brief Summary
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Objectives: To evaluate pressure pain thresholds, fatigue scales, quality of life and sleep quality, in women with Persistent Covid (PC), pre- and post-treatment using electrotherapy and in a placebo group of PC patients. Relevance: This trial can be a tool for patients affected by CP who present pain and fatigue problems, insomnia or signs of imbalance of their Autonomic Nervous System. It aims to improve their rest and recovery for a better quality of life that allows them to recover their Activities of Daily Living. We have designed the study with a commitment to placebo group treatment after completion, if positive results are obtained. A 6-month and 1-year follow-up will be scheduled. Secondary objectives: To analyze the effects on quality of life, fatigue and sleep. To analyze the presence of cardiac variability and pre- and post-treatment cortisol values. Patients and Methods: 12 patients with CP will receive 15 sessions of electrotherapy. 12 will receive a placebo. Mechanical sensitivity pre-post, by means of an algometer, cardiac variability, cortisol levels, and other variables, will be measured by means of questionnaires. Mechanical sensitivity to pain will be measured using an algometer (Baseline 12-0300 MMT). Patients will be instructed to report when the sensation of pressure changes to pain. The pre-post electrotherapy treatment described above will be measured, the differences in mechanical sensitivity, pain threshold to pressure, the Pittsburg questionnaires, SF-36, MFIS and EQooL-5. Follow-up will be done at 6 months and at one year. The study design is a triple-blind randomized controlled clinical trial. Patients who sign the consent form will be evaluated by an internist who will perform a physical examination at the clinic of the Faculty of Nursing and Physiotherapy of the Pontifical University of Salamanca (UPSA). The sample will be randomized. 12 patients will receive treatment and 12 patients will receive a placebo. With a commitment to treat these patients in the event that positive results are obtained after the end of the study. A biphasic microcurrent will be applied with a frequency between 1.14 Hertz and 14.29 Hertz and intensities between 0.1 and 0.9 mA. Frequency: 2 times a week. A total of 15 sessions in 7.5 weeks. The session time with microcurrents will last 60 minutes. .

Official Title
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Physiotherapy for Persistent Function by Superficial Neuromodulation

Conditions
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Post-Acute COVID-19 Syndrome, Dysautonomia, Neuromodulation

Intervention / Treatment
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* Device: Neuromodulation NESA NXSIGNAL® device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who have had symptoms of PC for more than one year. Signs of central sensitization. Exclusion Criteria: Previous treatment with surgery. Previous spinal trauma. Whiplash. Pregnancy situation. Previous musculoskeletal disease (rheumatoid arthritis, sympathetic-reflex dystrophy, fibromyalgia). Pacemaker. Electric drug pump. Skin sensitivity alterations. Analgesic or anxiolytic drug treatment during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: triple-blind randomized controlled clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>A two-phase microcurrent with a frequency between 1.14 Hertz and 14.29 Hertz and currents between 0.1 and 0.9 mA will be applied. A total of 15 sessions in 7.5 weeks. Twice a week. The session time with microcurrents will last 60 minutes. | Device: Neuromodulation NESA NXSIGNAL® device<br>* Good positioning of the NXSIGNAL® device, as well as proper programming, is of vital importance for the achievement of the objective. General guidelines will be established, which should always be followed with the application of NESA microcurrents, and specific guidelines for this particular study, in order to obtain as homogeneous a sample as possible and to bring the device programming as close as possible to the objective to be pursued in the clinical trial. General guidelines for the application of XSIGNAL®. The skin should be clean, free of creams and grease, so it will be necessary to clean with alcohol or similar. The placement of the gloves and socks of the device should follow the established protocols, paying attention to the location of each semielectrode in its anatomical position. The device has a color system to determine the location of each wire. The directional electrode will be placed in the cervical area at the superficial level between C6 and C7.<br>|
| Placebo Comparator: Placebo group<br>Microcurrent machines shall be operated in such a way that they have a light signal but do not emit current. Neither the physical therapists who place them nor the subjects will be able to distinguish current-emitting machines from placebo machines. A total of 15 sessions in 7.5 weeks. Twice a week. The session time with placebo will last 60 minutes. | Device: Neuromodulation NESA NXSIGNAL® device<br>* Good positioning of the NXSIGNAL® device, as well as proper programming, is of vital importance for the achievement of the objective. General guidelines will be established, which should always be followed with the application of NESA microcurrents, and specific guidelines for this particular study, in order to obtain as homogeneous a sample as possible and to bring the device programming as close as possible to the objective to be pursued in the clinical trial. General guidelines for the application of XSIGNAL®. The skin should be clean, free of creams and grease, so it will be necessary to clean with alcohol or similar. The placement of the gloves and socks of the device should follow the established protocols, paying attention to the location of each semielectrode in its anatomical position. The device has a color system to determine the location of each wire. The directional electrode will be placed in the cervical area at the superficial level between C6 and C7.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Pressure Threshold | Central sensitization by assessment of the Pressure Pain Threshold (PPU) in kg: Baseline 12-0300 MMT algometer at cervical C5-C6, dorsal D5-D6 and anterior tibial muscle. | Change from Baseline Pain Pressure Threshold at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life RELATED TO HEALTH | SF-36 questionnaire | Change from baseline quality of life related to health at 1 year | 
| Quality of life RELATED TO HEALTH | EuroQool-5-D questionnaire | Change from baseline quality of life related to health at 1 year | 
| effects on fatigue | MFIS questionnaire (Modificated Fatigue Impact Scale) | Change from Baseline fatigue at 1 year | 
| Quality of sleep | Pittsburg questionnaire | Change from Baseline Quality of Sleep at 1 year | 
| cardiac variability | HRV (cardiac variability) in ms 2. SDNN (Standard deviation of all R-R intervals) in ms 3. rMSSD (Root mean square of the union of adjacent R-R intervals) in ms | Change from Baseline Cardiac variability at 1 year | 
| Cortisol levels | Soma OFCII cube device in nmol/L | Change from Baseline Cortisol level at 1 year |