Characterization of Long Covid Pain in Primary Care

Chronic Pain Clinical Trial

Official title:

Determination and Characterization of Persistent Musculoskeletal Pain in Covid-19 Patients in Primary Care.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894642
• Other study ID #: LGCOVIDCS
• Status: Recruiting
• Start date: May 15, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: June 2023
• Source: University of Valladolid
• Contact: Federico Montero Cuadrado
• Phone: +34651529993
• Email: montercua1981[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Justification: among the sequelae of Covid-19 in clinical practice we frequently find persistent neuromusculoskeletal pain. Prevalence data and the underlying mechanisms of such pain are very limited in the scientific literature. Therefore, with this research we will try to answer these questions.

Main objective: to determine and characterize persistent musculoskeletal pain in Covid-19 patients.

Method: two phases. First, a descriptive cross-sectional study will be carried out to estimate the prevalence of Long Covid Pain (LCP). Second phase, a case-control study will be carried out using the sample obtained in the first phase as the population. The sample will be divided into two groups: post-Covid-19 patients with LCP and post-Covid-19 patients without persistent pain (control group). The two groups will be matched according to sex, age and level of severity of the pathology.

An assessment and comparison between groups will be made of the following variables: central sensitization, healthy physical condition and blood test values, which will be evaluated by means of physical examination, questionnaires and laboratory tests.

Applicability of the results: this is a pioneering project at the national level, which would determine more reliably the prevalence of LCP in postcovid and could be a first step in the search for the best therapeutic strategies for these patients. This would help to improve the quality of life of these patients and to better manage the social and healthcare resources used in their treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who have had Covid-19, with a confirmatory PCR+ test or positive antigen test and recorded in their primary care medical record.

• Subjects between 18-70 years old.

• Musculoskeletal pain of more than 12 weeks of evolution since the beginning of the infection.

• Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

• History of chronic musculoskeletal pain of more than 12 weeks of evolution prior to Covid-19.

• History of diagnosed major depression.

• Having a diagnosis of fibromyalgia prior to Covid-19 infection.

• Pregnancy.

• Pain of oncologic origin.

• Fracture or surgical intervention on the spine in the last year.

• Bladder or bowel incontinence.

• Saddle anesthesia.

Related Conditions & MeSH terms

• Chronic Pain
• Long COVID
• Musculoskeletal Pain

Intervention

Behavioral:
• 0
It is a case-control study, cross-sectional, so there is no intervention possible.

Locations

Country	Name	City	State
Spain	Universidad de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
University of Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (QoL)	EQ-5D questionnaire (Qualitave of Life 5 Dimension): The EQ-5D-3L is a brief multi-attribute health status measure composed of five questions with Likert response options (descriptive system) and a visual analogue scale (EQ-VAS). The descriptive system covers five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with three levels of severity in each dimension (no problems, some problems, and extreme problems).	1 day
Secondary	Pain Intensity	Visual Analog Scale, VAS (0-100mm).	1 day
Secondary	Areas of pain	body chart, McGill questionnaire	1 day
Secondary	Quantitative sensory tests	temporal summation, pain detection to pressure and conditioned modulation test	1 day
Secondary	Handgrip Strength assessment	With a manual dynamometer.	1 day