Physiotherapy for Persistent Function by Superficial Neuromodulation
NCT ID: NCT05681455
Last Updated: 2023-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2023-06-15
2023-07-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental group
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.
Neuromodulation NESA NXSIGNAL® device
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.
Placebo group
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.
Neuromodulation NESA NXSIGNAL® device
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.
Interventions
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Neuromodulation NESA NXSIGNAL® device
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.
Eligibility Criteria
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Inclusion Criteria
* Signs of central sensitization.
Exclusion Criteria
* 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.
18 Years
60 Years
FEMALE
No
Sponsors
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Universidad Rey Juan Carlos
OTHER
Responsible Party
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Josue Fernandez Carnero
Physiotherapy for Persistent Function by Superficial Neuromodulation
Locations
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Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine. Faculty of Health Sciences. Rey Juan Carlos University
Alcorcón, Madrid, Spain
Countries
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Facility Contacts
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References
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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.
Burgess 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 Links
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Other Identifiers
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22/32
Identifier Type: -
Identifier Source: org_study_id
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