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Completed

NCT Number: NCT06723821

Noninvasive Neuromodulation in the Management of Post-COVID Musculoskeletal Pain

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Nidovirales Infections Pain Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28805, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuromodulation group

Other

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

Neuromodulation sham group

Other

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

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: Change from Baseline at one month.

    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)

Secondary outcomes

  1. DN4 scale

    Time frame: Change from Baseline at one month.

    It is a clinician-administered questionnaire consisting of 10 items.Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient. These components refer to how the pain feels to the patient Three items are based on the clinical examination. The clinician assesses whether there is reduced sensation (hyposthesia) to touch or pinprick and whether light brushing increases or causes pain (allodynia).The 7 symptoms items are scored by interviewing the patient, and the 3 remaining items are scored by means of clinical examination. The scores are added and a score of 4 or more out of 10 is suggestive of neuropathic pain.

  2. Pittsburg Sleep Quality Index score

    Time frame: Change from Baseline at one month.

    IThe Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality.The scores range from 0 to 21 and the authors suggest that a score >5 be considered as a significant sleep disturbance.

  3. Hospital Anxiety and Depression Scale (HAND)

    Time frame: Change from Baseline at one month

    The HADS is a questionnaire widely used to evaluate anxiety and depression. A 14-item questionnaire to rate patient´s depression and anxiety. Each item has a 0-3 score indicating worse results with higher score

  4. Quality of life SF12

    Time frame: Change from Baseline at one month.

    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. A higher score is better outcome.

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

Effectiveness of Noninvasive Neuromodulation in Post-COVID Musculoskeletal Pain in the Short Term: Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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