NCT04632355

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

November 13, 2020

Last Update Submit

November 17, 2020

Conditions

Covid19

Keywords

Covid19Painmusculoskeletal

Outcome Measures

Primary Outcomes (4)

  • Self-reported Version of the Leeds Assessment of Neuropathic Symptoms and Signs

    the characterization of the pain. Total of 24. \> 11 neuropathic pain.

    Baseline

  • PainDETEC

    the characterization of the pain

    Baseline

  • EuroQol-5D

    To measure quality of life, grade ranging from 0 (the worst possible health status) to 100 (the best possible health status)

    Baseline

  • The Hospital Anxiety and Depression Scale

    To measure psychological status. 0-7 = Normal; 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case)

    Baseline

Interventions

InterviewOTHER

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

Also known as: COVID-19 survivors

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jorge Hugo Villafañe

Milan, 20121, Italy

Location

Related Publications (2)

  • 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.

    PMID: 32280973BACKGROUND

  • 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.

    PMID: 32609464BACKGROUND

MeSH Terms

Conditions

COVID-19Pain

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jorge H Villafañe

    Fondazione Don Carlo Gnocchi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge H Villafañe, Ph.D

CONTACT

3395857563mail@villafane.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 17, 2020

Study Start

December 1, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

November 19, 2020

Record last verified: 2020-11

Locations

IT(1)