Characterization of Long Covid Pain in Primary Care

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

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.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Pain; Chronic Pain; Long COVID
• Intervention / Treatment: Behavioral

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Federico Montero Cuadrado; Phone Number: +34651529993; Email: montercua1981@hotmail.com

Study Locations

• Spain
  • Valladolid, Spain, 47005
    • Recruiting
    • Universidad de Valladolid
    • Contact: Laura Barrero Santiago; Phone Number: +34605123288; Email: laura.barrero@uva.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Long Covid Pain Patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Long Covid Pain Patients	It is a case-control study, cross-sectional, so there is no intervention possible.
Control Group, healthy people; Patients that had had Covid-19 but did not developed chronic pain or other chronic symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Visual Analog Scale, VAS (0-100mm).	1 day
Areas of pain	body chart, McGill questionnaire	1 day
Quantitative sensory tests	temporal summation, pain detection to pressure and conditioned modulation test	1 day
Handgrip Strength assessment	With a manual dynamometer.	1 day

Collaborators and Investigators

• Sponsor: University of Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Pain; Primary health care; Long COVID; Musculoskeletal pain; Psychological factors
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Pain; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Chronic Disease; Post-Infectious Disorders; COVID-19; Chronic Pain; Musculoskeletal Pain; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: LGCOVIDCS