Long COVIDNCT05894642
Characterization of Long Covid Pain in Primary Care
An observational study of Long COVID and Chronic Pain, run by University of Valladolid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Long COVID, Chronic Pain, Musculoskeletal Pain
- What is being tested?
- 0
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2022to 1 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Long Covid Pain Patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Valladolid
Valladolid, 47005
Laura Barrero Santiago, +34605123288, laura.barrero@uva.es
About this study
Official title: 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.
Read more
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
- Being tested
- 0
- Keywords
- Long COVID, Chronic Pain, Musculoskeletal pain, Primary health care, Psychological factors
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0Behavioural
It is a case-control study, cross-sectional, so there is no intervention possible.
| Study group | Role | What they receive |
|---|---|---|
| Long Covid Pain Patients | Not described Receives: Behavioral: 0 | |
| Control Group, healthy people | Patients that had had Covid-19 but did not developed chronic pain or other chronic symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (4)
Pain Intensity
Visual Analog Scale, VAS (0-100mm).
Measured: 1 day
Areas of pain
body chart, McGill questionnaire
Measured: 1 day
Quantitative sensory tests
temporal summation, pain detection to pressure and conditioned modulation test
Measured: 1 day
Handgrip Strength assessment
With a manual dynamometer.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start15 May 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Barrero Santiago, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894642
- Sponsor's protocol ID
- LGCOVIDCS
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination and Characterization of Persistent Musculoskeletal Pain in Covid-19 Patients in Primary Care.
- ClinicalTrials.gov ID
- NCT05894642
- Acronym / sponsor ID
- LGCOVIDCS
- Conditions
- Long COVID, Chronic Pain, Musculoskeletal Pain
- Keywords
- Long COVID, Chronic Pain, Musculoskeletal pain, Primary health care, Psychological factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Long Covid Pain Patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0It is a case-control study, cross-sectional, so there is no intervention possible. | Behavioural | Long Covid Pain Patients |
Primary outcome
Quality of life (QoL)
Time frame: 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).
4 secondary outcomes
Pain Intensity
Time frame: 1 day
Areas of pain
Time frame: 1 day
Quantitative sensory tests
Time frame: 1 day
Handgrip Strength assessment
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID and Chronic Pain, run by University of Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Montero Cuadrado (+34651529993, montercua1981@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QoL) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.