Noninvasive Neuromodulation in the Management of Post-COVID Musculoskeletal Pain

Not Applicable

Recruiting

• Conditions: COVID-19; Musculoskeletal Pain

• Registration Number: NCT06723821
• Lead Sponsor: University of Alcala

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-06
• Study First Posted: 2024-12-09
• Study Start: 2024-12-15
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-03-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	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 Outcome Measures

Name	Time	Method
DN4 scale	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.
Pittsburg Sleep Quality Index score	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.
Hospital Anxiety and Depression Scale (HAND)	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
Quality of life SF12	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.

Trial Locations

Locations (1)

Centro Investigación Fisioterapia y Dolor; 🇪🇸 Alcalá De Henares, Madrid, Spain