COVID-19MUSLOCNCT05358119
Musculoskeletal Pain in Long COVID
An observational study of COVID-19 and Musculoskeletal Pain, run by University of Leeds at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Musculoskeletal Pain
- How many people
- 100 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 Apr 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We aim to recruit 100 individuals with new-onset musculoskeletal pain consistent with COVID-19.
Who may be able to join
- 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.
Who cannot join
- People with pre-covid chronic pain syndrome.
- Unable to provide informed consent.
- Specific exclusion for Electroencephalogram (EEG): Patients with history of epileptic seizures.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 1 recruiting
- Active, not recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, England, LS1 3EX
- Recruiting
Leeds Community Healthcare NHS Trust
Leeds, England, LS6 1PF
Manoj Sivan, MD, 01133922564, m.sivan@leeds.ac.uk
About this study
Official title: Characterising Musculoskeletal Pain in People Living With Long COVID - a Prospective Longitudinal Study
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.
Read the 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.
- Conditions
- COVID-19, Musculoskeletal Pain
- Medical subject headings
- COVID-19, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Patients with long COVID and new-onset musculoskeletal pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (7)
C19-YRS (Yorkshire Rehabilitation Scale)
C19-YRS (Yorkshire Rehabilitation Scale) is a Long COVID specific outcome measure developed by the CI (MS) and the Leeds Covid rehabilitation team. It gives a symptom severity score, functional disability score and overall health state score. It has been validated for use in Long COVID patients and has been shown to have good reliability. The scale will be used in this study to comprehensive measure the most relevant symptoms of Long COVID. This will allow us look at associations between MSK pain and other symptoms of Long COVID.
Measured: 18 months
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a screening instrument with 9 items, developed to measure depression. For each item the patients are asked to assess how much they were bothered by the symptoms over the last two weeks. There are four answer options: not at all (0), several days (1), more than half of the days (2), and nearly every day (3). The sum score (range 0 to 27) indicates the degree of depression, with scores of ≥5, ≥10, and ≥15 representing mild, moderate, and severe levels of depression.
Measured: 18 months
EuroQol 5D (EQ-5D-5L)
The EQ-5D-5L is a widely used generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (MOBILITY, SELFCARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, and unable to). The second part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating higher health utility, though health state preferences can differ between countries. This part of the questionnaire consists of a VAS on which the patient rates his / her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Measured: 18 months
Blood inflammatory markers
Blood test known as 'inflammatory markers' can detect inflammation in the body, caused by many diseases including infections and auto-immune conditions. It helps to distinguish between inflammatory and noninflammatory causes of pain. The blood tests will be undertaken in this study to perform the measurements of serum inflammatory markers at baseline and follow-up visits. This measurement will include inflammatory markers such as: IL-1β, IL-6 and TNF-α.
Measured: 18 months
Electroencephalogram sprectral analysis
It is an electrophysiological monitoring method to record electrical activity of the brain. It is typically non-invasive, with electrodes placed along the scalp. The procedure begins with the participant lying on the exam table or bed. The technician puts about 20 small sensors on the scalp. Theses sensors (electrodes) pick up electrical activity from neurons and send them back to a machine, they show up as series of lines records on paper or displayed on a computer screen. When recording begins, participants asked to remain still with their eyes open first, then with them closed
Measured: 18 months
Quantitative sensory testing (QST)
QST systems have been developed to assess and quantify sensory function in patients with neurologic symptoms or in those at risk of developing neurologic disease. QST measures the detection threshold of accurately calibrated sensory stimuli. investigates the submodalities of the somatosensory system, such as temperature, touch, vibration, and pain. It provides information on the state of peripheral sensory nerves, as well as pain perception and central sensitization.
Measured: 18 months
Timed Up and Go Test (TUG)
The timed up and go (TUG) is an outcome measure to assess balance and mobility. The TUG is recommended as a routine screening test for falls in guidelines published by the American Geriatric Society and the British Geriatric Society, and the National Institute of Clinical Evidence (NICE) guidelines also support use the TUG for assessment of gait and balance in the prevention of falls in older people. Participants start the test in a seated position, stand up upon a command to walk for 3 m, turn around and walk back to the chair and sit down. The participants supposed to complete this as quickly as possible, while being as comfortable and as safe as possible. A stopwatch measures the time (in seconds) above 12 second is considered as the cut-off.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start30 Apr 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Leeds Comunity Healthcare NHS Trust
- Responsible party
- Principal investigator, Dr Manoj Sivan, University of Leeds
- Investigators
- Manoj Sivan, MD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358119
- Sponsor's protocol ID
- 296125
- Acronym
- MUSLOC
- Status last verified
- Apr 2022
- First submitted
- 30 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will be made available on request
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising Musculoskeletal Pain in People Living With Long COVID - a Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT05358119
- Acronym / sponsor ID
- MUSLOC / 296125
- Conditions
- COVID-19, Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Leeds Comunity Healthcare NHS Trust
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | –Patients with long COVID and new-onset musculoskeletal pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We aim to recruit 100 individuals with new-onset musculoskeletal pain consistent with COVID-19.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- People with pre-covid chronic pain syndrome.
- Unable to provide informed consent.
- Specific exclusion for Electroencephalogram (EEG): Patients with history of epileptic seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brief Pain Inventory
Time frame: 18 months
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.
7 secondary outcomes
C19-YRS (Yorkshire Rehabilitation Scale)
Time frame: 18 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 18 months
EuroQol 5D (EQ-5D-5L)
Time frame: 18 months
Blood inflammatory markers
Time frame: 18 months
Electroencephalogram sprectral analysis
Time frame: 18 months
Quantitative sensory testing (QST)
Time frame: 18 months
Timed Up and Go Test (TUG)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: Undecided. This will be made available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj Sivan, MD principal investigator
University of Leeds
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Musculoskeletal Pain, run by University of Leeds at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manoj Sivan, MD (01133922564, m.sivan@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.