NCT05358119

Brief Summary

Long COVID is a new disease, with musculoskeletal pain being one of the common presenting symptoms. This longitudinal study will explore the long COVID musculoskeletal pain aetiology, pathophysiology, impact on function and quality of life, prognosis and its natural evolution.

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 Apr 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

April 30, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

2.4 years

First QC Date

April 30, 2022

Last Update Submit

April 30, 2022

Conditions

COVID-19Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

  • Brief Pain Inventory

    It is an outcome measures pain severity, the impact of pain on daily function, the location of pain, pain medications and amount of pain relief in the past 24 hours of past week. It is originally developed to assess cancer pain but has been shown to have utility in chronic pain (Tan et al., 2004), with acceptable internal consistency (Cronbach α 0.85 intensity and 0.88 for interference) a stable 2-factor structure, and sensitivity to change with treatment. Similar qualities have been demonstrated in patients with musculoskeletal pain (Celik et al., 2016). There is no scoring algorithm for the Brief Pain Inventory, but "worst pain" or the arithmetic mean of four severity items can be used as measures of pain severity, and the arithmetic mean of the seven interference items can be used as a measure of pain interference.

    18 months

Secondary Outcomes (7)

  • C19-YRS (Yorkshire Rehabilitation Scale)

    18 months

  • Patient Health Questionnaire-9 (PHQ-9)

    18 months

  • EuroQol 5D (EQ-5D-5L)

    18 months

  • Blood inflammatory markers

    18 months

  • Electroencephalogram sprectral analysis

    18 months

  • +2 more secondary outcomes

Study Arms (1)

Prospective cohort

Patients with long COVID and new-onset musculoskeletal pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We aim to recruit 100 individuals with new-onset musculoskeletal pain consistent with COVID-19.

You may qualify if:

  • Individuals who have tested positive for COVID-19 or self-reported symptoms of COVID-19 confirmed by an independent clinician.
  • New onset musculoskeletal pain that develops during or following an infection consistent with COVID-19, continues for 4 weeks or more and is not explained by an alternative diagnosis.
  • Age 18 years or older.
  • Ability of participant to understand and the willingness to sign a written informed consent document.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Ability of participant to read and understand English.

You may not qualify if:

  • People with pre-covid chronic pain syndrome.
  • Unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leeds Teaching Hospitals NHS Trust

Leeds, England, LS1 3EX, United Kingdom

ACTIVE NOT RECRUITING

Leeds Community Healthcare NHS Trust

Leeds, England, LS6 1PF, United Kingdom

RECRUITING

MeSH Terms

Conditions

COVID-19Musculoskeletal Pain

Condition Hierarchy (Ancestors)

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

Study Officials

  • Manoj Sivan, MD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manoj Sivan, MD

CONTACT

01133922564m.sivan@leeds.ac.uk

Ai Lyn Tan, FRCP

CONTACT

01133438545a.l.tan@leeds.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Consultant in Rehabilitation Medicine

Study Record Dates

First Submitted

April 30, 2022

First Posted

May 3, 2022

Study Start

April 30, 2022

Primary Completion

October 1, 2024

Study Completion

December 31, 2024

Last Updated

May 3, 2022

Record last verified: 2022-04

Locations

GB(2)