Noninvasive Neuromodulation in the Management of Post-COVID Musculoskeletal Pain

NCT ID: NCT06723821

Last Updated: 2025-06-03

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-11-15

Brief Summary

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Brief Summary:

The post-Covid syndrome is a problem that affects a significant number of people in the world. Among the most common symptoms is pain, and although there is no specific data on neuropathic pain and Covid, due to under-diagnosis, they may be closely related.

Non-invasive neuromodulation acts on the Central Nervous System through the bioelectrical stimulation of nervous tissue and modulation of the system nervous, and can be useful in acute, chronic and musculosqueletal pain, and in symptoms such as stress, anxiety and sleep disturbances.

The objective of this clinical trial is to assess the efficacy of non-invasive neuromodulation in the treatment of post-Covid musculoskeletal pain. Subjects will be randomly divided into two groups: an experimental group in which non-invasive neuromodulation will be applied and a sham group to which it will be applied off. The variables to be studied before, during and after treatment will be neuropathic pain with the DN4 questionnaire, pain intensity with the EVA scale, sleep quality with the Pittsburgh Sleep Quality Index, level of stress and anxiety with the HADS questionnaire and quality of life with the SF12.

Detailed Description

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Conditions

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COVID-19 Musculoskeletal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Neuromodulation experimental group

The total number of sessions to be carried out on each patient will be 12 sessions, spread over 4 weeks.

The frequency will be 3 times a week. Each session with NESA microcurrents will last 60 minutes.

Group Type EXPERIMENTAL

Neuromodulation group

Intervention Type OTHER

During the 12 sessions of which the treatment consists in applying 60 minutes of microcurrent in low intensity.

Neuromodulation sham group

The total number of sessions to be carried out on each patient will be 12 sessions, spread over 4 weeks.

The frequency will be 3 times a week. Each session with NESA microcurrents will last 60 minutes.The treatment will be applied with a placebo device that does not emit microcurrent but that has the same function

Group Type SHAM_COMPARATOR

Neuromodulation sham group

Intervention Type OTHER

During the 12 sessions of which the treatment consists in applying 60 minutes of sham microcurrent in low intensity.

Interventions

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Neuromodulation group

During the 12 sessions of which the treatment consists in applying 60 minutes of microcurrent in low intensity.

Intervention Type OTHER

Neuromodulation sham group

During the 12 sessions of which the treatment consists in applying 60 minutes of sham microcurrent in low intensity.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Positive result in PCR or antigen test for detecting COVID-19 in the last 3 months.
* Present musculoskeletal pain in the last 3 months.
* Age between 18 to 65 years old.
* Score equal or superior to 4 in DN4 scale.

Exclusion Criteria

* Present musculoskeletal pain of traumatic origin or known cause
* Present musculoskeletal pain with more than 3 months of evolution.
* Pregnant women
* Present of vascular alterations, malignancy, thrombophlebitis or fever.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Daniel Pecos Martín

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Pecos-Martin, PhD

Role: STUDY_DIRECTOR

Alcala University

Locations

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Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Patricia M Merinero, PhD

Role: CONTACT

661637862

Facility Contacts

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Patricia Martinez-Merinero, PhD

Role: primary

683378391

Laura Cabellos

Role: backup

683378391

Other Identifiers

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CEIM/2022/6/121

Identifier Type: -

Identifier Source: org_study_id

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