search
Back to results

Physiotherapy for Persistent Function by Superficial Neuromodulation

Primary Purpose

Post-Acute COVID-19 Syndrome, Dysautonomia, Neuromodulation

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neuromodulation NESA NXSIGNAL® device
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Acute COVID-19 Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine. Faculty of Health Sciences. Rey Juan Carlos UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of life RELATED TO HEALTH
SF-36 questionnaire
Quality of life RELATED TO HEALTH
EuroQool-5-D questionnaire
effects on fatigue
MFIS questionnaire (Modificated Fatigue Impact Scale)
Quality of sleep
Pittsburg questionnaire
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
Cortisol levels
Soma OFCII cube device in nmol/L

Full Information

First Posted
December 5, 2022
Last Updated
June 5, 2023
Sponsor
Universidad Rey Juan Carlos
search

1. Study Identification

Unique Protocol Identification Number
NCT05681455
Brief Title
Physiotherapy for Persistent Function by Superficial Neuromodulation
Official Title
Physiotherapy for Persistent Function by Superficial Neuromodulation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Acute COVID-19 Syndrome, Dysautonomia, Neuromodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
triple-blind randomized controlled clinical trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Neuromodulation NESA NXSIGNAL® device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Pressure Threshold
Description
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.
Time Frame
Change from Baseline Pain Pressure Threshold at 1 year
Secondary Outcome Measure Information:
Title
Quality of life RELATED TO HEALTH
Description
SF-36 questionnaire
Time Frame
Change from baseline quality of life related to health at 1 year
Title
Quality of life RELATED TO HEALTH
Description
EuroQool-5-D questionnaire
Time Frame
Change from baseline quality of life related to health at 1 year
Title
effects on fatigue
Description
MFIS questionnaire (Modificated Fatigue Impact Scale)
Time Frame
Change from Baseline fatigue at 1 year
Title
Quality of sleep
Description
Pittsburg questionnaire
Time Frame
Change from Baseline Quality of Sleep at 1 year
Title
cardiac variability
Description
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
Time Frame
Change from Baseline Cardiac variability at 1 year
Title
Cortisol levels
Description
Soma OFCII cube device in nmol/L
Time Frame
Change from Baseline Cortisol level at 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine. Faculty of Health Sciences. Rey Juan Carlos University
City
Alcorcón
State/Province
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofía Laguarta-Val, PhD
Phone
00344888662
Email
sofia.laguarta@urjc.es
First Name & Middle Initial & Last Name & Degree
Sofía Laguarta-Val, PT,MsC,PhD
First Name & Middle Initial & Last Name & Degree
Alberto Melián-Ortiz, PT,MsC,PhD
First Name & Middle Initial & Last Name & Degree
Josué Fernández-Carnero, PT,MsC,PhD
First Name & Middle Initial & Last Name & Degree
Carmen Jiménez-Antona, PT,MsC,PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33830208
Citation
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.
Results Reference
background
PubMed Identifier
33634830
Citation
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.
Results Reference
result
Links:
URL
https://www.semg.es/index.php/consensos-guias-y-protocolos/363-guia-clinica-para-la-atencion-al-paciente-long-covid-covid-persistente
Description
Related Info

Learn more about this trial

Physiotherapy for Persistent Function by Superficial Neuromodulation

We'll reach out to this number within 24 hrs