Covid19-Pain: Musculoskeletal Pain in Patients With Covid-19 Who Have Hospital Care

Sponsor

Fondazione Don Carlo Gnocchi Onlus (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04632355

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Other: Interview

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

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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?

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Jul 31, 2021

Outcome Measures

Primary Outcome Measures

Self-reported Version of the Leeds Assessment of Neuropathic Symptoms and Signs [Baseline]
the characterization of the pain. Total of 24. > 11 neuropathic pain.
PainDETEC [Baseline]
the characterization of the pain
EuroQol-5D [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 [Baseline]
To measure psychological status. 0-7 = Normal; 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Recovered from COVID-19 infection.
COVID-19 survivors after hospitalization.
Musculoskeletal pain.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jorge Hugo Villafañe	Milan		Italy	20121

Sponsors and Collaborators

Fondazione Don Carlo Gnocchi Onlus

Investigators

Principal Investigator: Jorge H Villafañe, Fondazione Don Carlo Gnocchi

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Jorge Hugo Villafañe, PhD, Researcher, Fondazione Don Carlo Gnocchi Onlus

ClinicalTrials.gov Identifier:

NCT04632355

Other Study ID Numbers:

Covid19-Pain

First Posted:

Nov 17, 2020

Last Update Posted:

Nov 19, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jorge Hugo Villafañe, PhD, Researcher, Fondazione Don Carlo Gnocchi Onlus

Covid19

Pain

musculoskeletal

Additional relevant MeSH terms:

COVID-19

Musculoskeletal Pain

Study Results

No Results Posted as of Nov 19, 2020