Characterization of Long Covid Pain in Primary Care

NCT05894642 | Unknown

• 1 other identifier: LGCOVIDCS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long COVID; Chronic Pain; Musculoskeletal Pain

Keywords

Long COVID; Chronic Pain; Musculoskeletal pain; Primary health care; Psychological factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain Intensity

  1 day

• Areas of pain

  1 day

• Quantitative sensory tests

  1 day

• Handgrip Strength assessment

  1 day

Study Arms (2)

Long Covid Pain Patients

Behavioral: 0

Control Group, healthy people

Patients that had had Covid-19 but did not developed chronic pain or other chronic symptoms.

Interventions

0 BEHAVIORAL

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

Long Covid Pain Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Long Covid Pain Patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valladolid: lead

Study Sites (1)

Universidad de Valladolid

Valladolid, 47005, Spain

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Central Study Contacts

Federico Montero Cuadrado

CONTACT

+34651529993; montercua1981@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Candidate

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 8, 2023
• Study Start: May 15, 2022
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

ES (1)