Covid19Covid19-PainNCT04632355
Musculoskeletal Pain in Patients With Covid-19 Who Have Hospital Care
An observational study of Covid19, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Worldwide, the COVID-19 pandemic continues to grow. Although COVID-19 mainly affects the lungs and internal organs, musculoskeletal injury from this disease was reported with the presentation of marked elevation in creatine kinase and lactate dehydrogenase levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Interview
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 31 Jul 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who had been recovered from COVID-19 infection, that is, COVID-19 survivors after hospitalization in the abovementioned Hospitals of Italy.
Who may be able to join
- Recovered from COVID-19 infection.
- COVID-19 survivors after hospitalization.
- Musculoskeletal pain.
Who cannot join
- Participants will be excluded also if they score greater than 6 points on the Beck Depression Inventory (BDI) or more than 30 points in the State Trait Anxiety Inventory (STAI), dementia and not Italian speaking due to the high level of language skills required for questionnaires and quantitative sensory testing.
- Psychiatric or neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: After the First and Second Wave in Italy: What Effects of Musculoskeletal Pain Did the Covid-19 in Patients Who Have Hospital Care?
Worldwide, the COVID-19 pandemic continues to grow. Although COVID-19 mainly affects the lungs and internal organs, musculoskeletal injury from this disease was reported with the presentation of marked elevation in creatine kinase and lactate dehydrogenase levels. Patients with post-acute COVID-19 are considered patients with a post-intensive syndrome (PICS) that results in loss of functional independence.
In the physical and rehabilitation medical field, various modalities with therapeutic exercise can be used to manage pain by a physical therapist and psychiatrist.
Pain management is particularly important during the COVID-19 pandemic because of the reduced accessibility to hospitals and medical resources.
Read the detailed description
The COVID-19 survivors with pain symptoms will participated. In this phase, a face-to-face interview will be conducted to collecting all outcomes about pain.
- Conditions
- Covid19
- Being tested
- Interview
- Keywords
- Covid19, Pain, musculoskeletal
- Medical subject headings
- COVID-19, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Also called COVID-19 survivors
This interview will be conducted to collecting all outcomes about musculoskeletal pain in COVID-19 survivors
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Version of the Leeds Assessment of Neuropathic Symptoms and Signs
the characterization of the pain. Total of 24. > 11 neuropathic pain.
Measured: Baseline
PainDETEC
the characterization of the pain
Measured: Baseline
EuroQol-5D
To measure quality of life, grade ranging from 0 (the worst possible health status) to 100 (the best possible health status)
Measured: Baseline
The Hospital Anxiety and Depression Scale
To measure psychological status. 0-7 = Normal; 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Jorge H Villafañe, Principal investigator, Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632355
- Sponsor's protocol ID
- Covid19-Pain
- Acronym
- Covid19-Pain
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pedersini P, Corbellini C, Villafane JH. Italian Physical Therapists' Response to the Novel COVID-19 Emergency. Phys Ther. 2020 Jul 19;100(7):1049-1051. doi: 10.1093/ptj/pzaa060. No abstract available.
PubMed 32280973Pancera S, Galeri S, Porta R, Pietta I, Bianchi LNC, Carrozza MC, Villafane JH. Feasibility and Efficacy of the Pulmonary Rehabilitation Program in a Rehabilitation Center: CASE REPORT OF A YOUNG PATIENT DEVELOPING SEVERE COVID-19 ACUTE RESPIRATORY DISTRESS SYNDROME. J Cardiopulm Rehabil Prev. 2020 Jul;40(4):205-208. doi: 10.1097/HCR.0000000000000529.
PubMed 32609464
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- After the First and Second Wave in Italy: What Effects of Musculoskeletal Pain Did the Covid-19 in Patients Who Have Hospital Care?
- ClinicalTrials.gov ID
- NCT04632355
- Acronym / sponsor ID
- Covid19-Pain / Covid19-Pain
- Conditions
- Covid19
- Keywords
- Covid19, Pain, musculoskeletal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 17 Nov 2020 (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.
Worldwide, the COVID-19 pandemic continues to grow. Although COVID-19 mainly affects the lungs and internal organs, musculoskeletal injury from this disease was reported with the presentation of marked elevation in creatine kinase and lactate dehydrogenase levels. Patients with post-acute COVID-19 are considered patients with a post-intensive syndrome (PICS) that results in loss of functional independence.
In the physical and rehabilitation medical field, various modalities with therapeutic exercise can be used to manage pain by a physical therapist and psychiatrist.
Pain management is particularly important during the COVID-19 pandemic because of the reduced accessibility to hospitals and medical resources.
Detailed description
The COVID-19 survivors with pain symptoms will participated. In this phase, a face-to-face interview will be conducted to collecting all outcomes about pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had been recovered from COVID-19 infection, that is, COVID-19 survivors after hospitalization in the abovementioned Hospitals of Italy.
Key inclusion criteria (3 listed)
- Recovered from COVID-19 infection.
- COVID-19 survivors after hospitalization.
- Musculoskeletal pain.
Key exclusion criteria (2 listed)
- Participants will be excluded also if they score greater than 6 points on the Beck Depression Inventory (BDI) or more than 30 points in the State Trait Anxiety Inventory (STAI), dementia and not Italian speaking due to the high level of language skills required for questionnaires and quantitative sensory testing.
- Psychiatric or neurological disorders
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 |
|---|---|---|
| InterviewAlso: COVID-19 survivorsThis interview will be conducted to collecting all outcomes about musculoskeletal pain in COVID-19 survivors | Other | – |
Primary outcome
Self-reported Version of the Leeds Assessment of Neuropathic Symptoms and Signs
Time frame: Baseline
the characterization of the pain. Total of 24. > 11 neuropathic pain.
PainDETEC
Time frame: Baseline
the characterization of the pain
EuroQol-5D
Time frame: Baseline
To measure quality of life, grade ranging from 0 (the worst possible health status) to 100 (the best possible health status)
The Hospital Anxiety and Depression Scale
Time frame: Baseline
To measure psychological status. 0-7 = Normal; 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Background: PubMed 32280973Pedersini P, Corbellini C, Villafane JH. Italian Physical Therapists' Response to the Novel COVID-19 Emergency. Phys Ther. 2020 Jul 19;100(7):1049-1051. doi: 10.1093/ptj/pzaa060. No abstract available.
- Background: PubMed 32609464Pancera S, Galeri S, Porta R, Pietta I, Bianchi LNC, Carrozza MC, Villafane JH. Feasibility and Efficacy of the Pulmonary Rehabilitation Program in a Rehabilitation Center: CASE REPORT OF A YOUNG PATIENT DEVELOPING SEVERE COVID-19 ACUTE RESPIRATORY DISTRESS SYNDROME. J Cardiopulm Rehabil Prev. 2020 Jul;40(4):205-208. doi: 10.1097/HCR.0000000000000529.
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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.
Jorge H Villafañe principal investigator
Fondazione Don Carlo Gnocchi
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 Covid19, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 3 inclusion and 2 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 19 Nov 2020. 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 Italy. 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 Jorge H Villafañe, Ph.D (3395857563, mail@villafane.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Version of the Leeds Assessment of Neuropathic Symptoms and Signs (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632355, which also lists 2 linked publications.
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 19 Nov 2020.