Characterization of Long Covid Pain in Primary Care

Sponsor

University of Valladolid (Other)

Overall Status

Recruiting

CT.gov ID

NCT05894642

Collaborator

(none)

300

Enrollment

Location

20.6

Anticipated Duration (Months)

14.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Long COVID Chronic Pain Musculoskeletal Pain	Behavioral: 0

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

May 15, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Long Covid Pain Patients	Behavioral: 0 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.

Arm

Intervention/Treatment

Long Covid Pain Patients

Behavioral: 0

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.

Outcome Measures

Primary Outcome Measures

Quality of life (QoL) [1 day]
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).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.