Physiotherapy for Persistent Function by Superficial Neuromodulation

Universidad Rey Juan Carlos

Status: Enrolling

Conditions: Post-Acute COVID-19 Syndrome; Dysautonomia; Neuromodulation

Treatments: Device: Neuromodulation NESA NXSIGNAL® device

Study type: Interventional

Funder types: Other

Identifiers

NCT05681455

22/32

Details and patient eligibility

About

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.

.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

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.

Treatment:

Device: Neuromodulation NESA NXSIGNAL® device

Placebo group

Placebo Comparator group

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.

Treatment:

Device: Neuromodulation NESA NXSIGNAL® device