Clinical trial NCT05894642: Characterization of Long Covid Pain in Primary Care
Official title: Determination and Characterization of Persistent Musculoskeletal Pain in Covid-19 Patients in Primary Care.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long COVID
Chronic Pain
Musculoskeletal Pain
Keywords: Long COVID
Chronic Pain
Musculoskeletal pain
Primary health care
Psychological factors
Lead sponsor: University of Valladolid
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long Covid Pain Patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life (QoL)
timeFrame: 1 day
Secondary outcomes:
measure: Pain Intensity
timeFrame: 1 day
measure: Areas of pain
timeFrame: 1 day
measure: Quantitative sensory tests
timeFrame: 1 day
measure: Handgrip Strength assessment
timeFrame: 1 day
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Universidad de Valladolid
Study officials:
References: