Post-Acute COVID-19 SyndromeNCT05681455
Physiotherapy for Persistent Function by Superficial Neuromodulation
A study testing Neuromodulation NESA NXSIGNAL® device in people with Post-Acute COVID-19 Syndrome and Dysautonomia, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Post-Acute COVID-19 Syndrome, Dysautonomia, Neuromodulation
- What is being tested?
- Neuromodulation NESA NXSIGNAL® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2023to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who have had symptoms of PC for more than one year.
- Signs of central sensitization.
Who cannot join
- Previous treatment with surgery.
- Previous spinal trauma.
- Whiplash.
- Pregnancy situation.
- Previous musculoskeletal disease (rheumatoid arthritis, sympathetic-reflex dystrophy, fibromyalgia).
- Pacemaker.
Show all 9Show fewer
- Electric drug pump.
- Skin sensitivity alterations.
- Analgesic or anxiolytic drug treatment during the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine. Faculty of Health Sciences. Rey Juan Carlos University
Alcorcón, Madrid
Sofía Laguarta-Val, PhD, 00344888662, sofia.laguarta@urjc.es
Sofía Laguarta-Val, PT,MsC,PhD
About this study
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.
Read more
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.
.
- Conditions
- Post-Acute COVID-19 Syndrome, Dysautonomia, Neuromodulation
- Being tested
- Neuromodulation NESA NXSIGNAL® device
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromodulation NESA NXSIGNAL® deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Device: Neuromodulation NESA NXSIGNAL® device |
| Placebo group | Placebo comparator | 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. Receives: Device: Neuromodulation NESA NXSIGNAL® device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Pain Pressure Threshold at 1 year
Secondary outcomes (6)
Quality of life RELATED TO HEALTH
SF-36 questionnaire
Measured: Change from baseline quality of life related to health at 1 year
Quality of life RELATED TO HEALTH
EuroQool-5-D questionnaire
Measured: Change from baseline quality of life related to health at 1 year
effects on fatigue
MFIS questionnaire (Modificated Fatigue Impact Scale)
Measured: Change from Baseline fatigue at 1 year
Quality of sleep
Pittsburg questionnaire
Measured: 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
Measured: Change from Baseline Cardiac variability at 1 year
Cortisol levels
Soma OFCII cube device in nmol/L
Measured: Change from Baseline Cortisol level at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start15 Jun 2023 (estimated)
- Primary completion15 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- triple-blind randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681455
- Sponsor's protocol ID
- 22/32
- Status last verified
- Jun 2023
- First submitted
- 5 Dec 2022
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaber TAK, Ashish A, Unsworth A. Persistent post-covid symptoms in healthcare workers. Occup Med (Lond). 2021 Jun 16;71(3):144-146. doi: 10.1093/occmed/kqab043.
PubMed 33830208Burgess LC, Venugopalan L, Badger J, Street T, Alon G, Jarvis JC, Wainwright TW, Everington T, Taylor P, Swain ID. Effect of neuromuscular electrical stimulation on the recovery of people with COVID-19 admitted to the intensive care unit: A narrative review. J Rehabil Med. 2021 Mar 18;53(3):jrm00164. doi: 10.2340/16501977-2805.
PubMed 33634830
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy for Persistent Function by Superficial Neuromodulation
- ClinicalTrials.gov ID
- NCT05681455
- Acronym / sponsor ID
- 22/32
- Conditions
- Post-Acute COVID-19 Syndrome, Dysautonomia, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- triple-blind randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Neuromodulation NESA NXSIGNAL® deviceA 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. |
| Placebo group | Placebo comparator | Device: Neuromodulation NESA NXSIGNAL® deviceMicrocurrent 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women who have had symptoms of PC for more than one year.
- Signs of central sensitization.
Key exclusion criteria (9 listed)
- Previous treatment with surgery.
- Previous spinal trauma.
- Whiplash.
- Pregnancy situation.
- Previous musculoskeletal disease (rheumatoid arthritis, sympathetic-reflex dystrophy, fibromyalgia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromodulation NESA NXSIGNAL® deviceGood 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. | Device | Experimental group, Placebo group |
Primary outcome
Pain Pressure Threshold
Time frame: Change from Baseline Pain Pressure Threshold at 1 year
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.
6 secondary outcomes
Quality of life RELATED TO HEALTH
Time frame: Change from baseline quality of life related to health at 1 year
Quality of life RELATED TO HEALTH
Time frame: Change from baseline quality of life related to health at 1 year
effects on fatigue
Time frame: Change from Baseline fatigue at 1 year
Quality of sleep
Time frame: Change from Baseline Quality of Sleep at 1 year
cardiac variability
Time frame: Change from Baseline Cardiac variability at 1 year
Cortisol levels
Time frame: Change from Baseline Cortisol level at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Background: PubMed 33830208Gaber TAK, Ashish A, Unsworth A. Persistent post-covid symptoms in healthcare workers. Occup Med (Lond). 2021 Jun 16;71(3):144-146. doi: 10.1093/occmed/kqab043.
- Results publication: PubMed 33634830Burgess LC, Venugopalan L, Badger J, Street T, Alon G, Jarvis JC, Wainwright TW, Everington T, Taylor P, Swain ID. Effect of neuromuscular electrical stimulation on the recovery of people with COVID-19 admitted to the intensive care unit: A narrative review. J Rehabil Med. 2021 Mar 18;53(3):jrm00164. doi: 10.2340/16501977-2805.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine. Faculty of Health Sciences. Rey Juan Carlos University
Alcorcón, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromodulation NESA NXSIGNAL® device in people with Post-Acute COVID-19 Syndrome and Dysautonomia, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Pressure Threshold (time frame: Change from Baseline Pain Pressure Threshold at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05681455, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.