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

Covid19 Clinical Trial

— Covid19-Pain  

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?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04632355
• Other study ID #: Covid19-Pain
• Status: Not yet recruiting
• Start date: December 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: November 2020
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Jorge H Villafañe, Ph.D
• Phone: 3395857563
• Email: mail[@]villafane.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Musculoskeletal Pain

Intervention

Other:
• Interview
This interview will be conducted to collecting all outcomes about musculoskeletal pain in COVID-19 survivors

Locations

Country	Name	City	State
Italy	Jorge Hugo Villafañe	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Pancera S, Galeri S, Porta R, Pietta I, Bianchi LNC, Carrozza MC, Villafañe 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. Review. — View Citation

Pedersini P, Corbellini C, Villafañe 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported Version of the Leeds Assessment of Neuropathic Symptoms and Signs	the characterization of the pain. Total of 24. > 11 neuropathic pain.	Baseline
Primary	PainDETEC	the characterization of the pain	Baseline
Primary	EuroQol-5D	To measure quality of life, grade ranging from 0 (the worst possible health status) to 100 (the best possible health status)	Baseline
Primary	The Hospital Anxiety and Depression Scale	To measure psychological status. 0-7 = Normal; 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case)	Baseline