Characterization of Long Covid Pain in Primary Care

NCT ID: NCT05894642

Last Updated: 2023-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-15

Study Completion Date

2024-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Long COVID Chronic Pain Musculoskeletal Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Long Covid Pain Patients

0

Intervention Type BEHAVIORAL

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.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

0

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Valladolid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Laura Barrero Santiago

Phd Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidad de Valladolid

Valladolid, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Federico Montero Cuadrado

Role: CONTACT

+34651529993

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Laura Barrero Santiago

Role: primary

+34605123288

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LGCOVIDCS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

3h of PNE on BDNF and Pain Levels
NCT05736172 RECRUITING NA
Education on BDNF on Pain Levels
NCT05623579 RECRUITING NA