Noninvasive Neuromodulation in the Management of Post-COVID Musculoskeletal Pain

NCT06723821 | Completed

• 1 other identifier: CEIM/2022/6/121
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health), orientated from the left (worst) to the right (best)

  Change from Baseline at one month.

Secondary Outcomes (4)

• DN4 scale

  Change from Baseline at one month.

• Pittsburg Sleep Quality Index score

  Change from Baseline at one month.

• Hospital Anxiety and Depression Scale (HAND)

  Change from Baseline at one month

• Quality of life SF12

  Change from Baseline at one month.

Study Arms (2)

Neuromodulation experimental group

EXPERIMENTAL

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.

Other: Neuromodulation group

Neuromodulation sham group

SHAM COMPARATOR

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

Other: Neuromodulation sham group

Interventions

Neuromodulation group OTHER

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

Neuromodulation experimental group

Neuromodulation sham group OTHER

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

Neuromodulation sham group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

COVID-19; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Pecos-Martin, PhD

  Alcala University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 15, 2024
• Primary Completion: October 15, 2025
• Study Completion: April 15, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

ES (1)