Noninvasive Neuromodulation in the Management of Post-COVID Musculoskeletal Pain

University of Alcala

Status: Enrolling

Conditions: Musculoskeletal Pain; COVID-19

Treatments: Other: Neuromodulation group; Other: Neuromodulation sham group

Study type: Interventional

Funder types: Other

Identifiers

NCT06723821

CEIM/2022/6/121

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Neuromodulation experimental group

Experimental group

Description:

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.

Treatment:

Other: Neuromodulation group

Neuromodulation sham group

Sham Comparator group

Description:

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

Treatment:

Other: Neuromodulation sham group