Clinical trial NCT04632355: Musculoskeletal Pain in Patients With Covid-19 Who Have Hospital Care
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?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Covid19
Pain
musculoskeletal
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had been recovered from COVID-19 infection, that is, COVID-19 survivors after hospitalization in the abovementioned Hospitals of Italy.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported Version of the Leeds Assessment of Neuropathic Symptoms and Signs
timeFrame: Baseline
measure: PainDETEC
timeFrame: Baseline
measure: EuroQol-5D
timeFrame: Baseline
measure: The Hospital Anxiety and Depression Scale
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Jorge Hugo Villafañe
Study officials:
affiliation: Fondazione Don Carlo Gnocchi
name: Jorge H Villafañe
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Pancera 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.