Clinical trial NCT05358119: Musculoskeletal Pain in Long COVID
Official title: Characterising Musculoskeletal Pain in People Living With Long COVID - a Prospective Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Musculoskeletal Pain
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Leeds Comunity Healthcare NHS Trust
First posted: 2022-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We aim to recruit 100 individuals with new-onset musculoskeletal pain consistent with COVID-19.

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.

Detailed description: Long COVID is defined as signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than four weeks and are not explained by an alternative diagnosis. It has been estimated there are 2 million people in the UK alone with long COVID symptoms. Most people with long COVID experience some limitation to their daily activities. This causes new challenges to the patients and their families as well as to the healthcare system. Musculoskeletal (MSK) pain is one of the most common reported symptoms in long COVID. The causes and underlying mechanisms of MSK pain in long COVID are not fully understood yet. A few underlying mechanisms have been hypothesised to cause the pain including detrimental impacts of the virus on neurological functions and central nervous system; immunologic aberrations and inflammatory damage in response to the acute infection; expected sequelae of post-critical illness involving deconditioning process following a period of inactivity, bed rest or sedentary lifestyle associated with the viral infection.

The purpose of this study is to investigate the clinical characteristics, etiopathological mechanisms and the natural course of pain, and to understand its physical and psychosocial consequences. We will also analyse the correlation of pain to clusters of long COVID symptoms. We anticipate the results of this study will help the healthcare providers to deliver adequate management for patients with long COVID.

This is a longitudinal study to observe 100 patients with long COVID pain throughout an 18-month period. Pain assessment will be undertaken using validated methods, that include blood tests to detect inflammatory biomarkers, clinical examination, standardised pain instruments/scales, Quantitative Sensory Testing to measure changes in sensitivity, and electroencephalography to measure brain network activity. Physical activity measurements include Timed Up and Go Test to assess balance and mobility, Rated Perceived Exertion Scale to measure exercise intensity, and Hand-Grip Dynamometer test to measure handgrip strength. In addition, we will use psychological assessment tools to assess the severity of depression and anxiety, and self-efficacy and pain-related thoughts.

Eligibility criteria: Inclusion Criteria:

1. Individuals who have tested positive for COVID-19 or self-reported symptoms of COVID-19 confirmed by an independent clinician.
2. 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.
3. Age 18 years or older.
4. Ability of participant to understand and the willingness to sign a written informed consent document.
5. Stated willingness to comply with all study procedures and availability for the duration of the study.
6. Ability of participant to read and understand English.

Exclusion Criteria:

1. People with pre-covid chronic pain syndrome.
2. Unable to provide informed consent.
3. Specific exclusion for Electroencephalogram (EEG): Patients with history of epileptic seizures.

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: 18 months
Secondary outcomes:
measure: C19-YRS (Yorkshire Rehabilitation Scale)
timeFrame: 18 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 18 months
measure: EuroQol 5D (EQ-5D-5L)
timeFrame: 18 months
measure: Blood inflammatory markers
timeFrame: 18 months
measure: Electroencephalogram sprectral analysis
timeFrame: 18 months
measure: Quantitative sensory testing (QST)
timeFrame: 18 months
measure: Timed Up and Go Test (TUG)
timeFrame: 18 months
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: England
city: Leeds
country: United Kingdom
facility: Leeds Community Healthcare NHS Trust
state: England
Study officials:
affiliation: University of Leeds
name: Manoj Sivan, MD
role: PRINCIPAL_INVESTIGATOR
References: