Musculoskeletal DiseasesNCT04632563
Prevalence of Musculoskeletal Symptoms in the Cambridge NIHR BioResource
An observational study of Musculoskeletal Diseases and Musculoskeletal Injury, run by Cambridge University Hospitals NHS Foundation Trust.
Trial summary
Musculoskeletal diseases, such as osteoarthritis, represent a large proportion of the global burden of disease with hip and knee osteoarthritis alone being the 11th greatest cause of disease burden. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases, Musculoskeletal Injury
- What is being tested?
- Questionnaire including MSK-HQ (Musculoskeletal Health Questionnaire)
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Aug 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All members of the Cambridge NIHR BioResource
Who may be able to join
- Member of the NIHR BioResource
- Willing to consent to participate
Who cannot join
- Previous self-report of osteoarthritis on joining BioResource
Trial locations and contacts
No sites are listed yet.
About this study
Musculoskeletal diseases, such as osteoarthritis, represent a large proportion of the global burden of disease with hip and knee osteoarthritis alone being the 11th greatest cause of disease burden.
The purpose of this study is to determine the level of musculoskeletal symptoms in members of the Cambridge National Institute for Health Research (NIHR) BioResource and see if this is associated with their possession of genetic markers that have been identified as being associated with osteoarthritis.
This will allow us to determine the real level of musculoskeletal symptoms in this large cohort of volunteers and provide basic information that could be used to facilitate further musculoskeletal research in the NIHR BioResource population.
Read the detailed description
All active members of the Cambridge NIHR BioResource will be approached.
They will be sent an email outlining the purpose of the study and asking that if they would like to take part to please complete the online questionnaire which will be linked to in the email.
For those individuals who agree to participate and complete the questionnaire, the Cambridge NIHR BioResource will provide the genetic marker information it already holds for specific markers that are known to be associated with osteoarthritis.
- Conditions
- Musculoskeletal Diseases, Musculoskeletal Injury
- Being tested
- Questionnaire including MSK-HQ (Musculoskeletal Health Questionnaire)
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire including MSK-HQ (Musculoskeletal Health Questionnaire)Other
A questionnaire regarding musculoskeletal past medical history and current symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Member of BioResource | Any BioResource member who consents to take part in the study and completes the study questionnaire. Receives: Other: Questionnaire including MSK-HQ (Musculoskeletal Health Questionnaire) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSK Symptom Levels
Musculoskeletal Symptoms in respondents
Measured: 3 months
Osteoarthritis genetic marker
Possession (or not) of specific genetic markers for osteoarthritis (obtained from information already held by the NIHR BioResource)
Measured: 6 months
Secondary outcomes (1)
MSK Cohort
Identification of those with particular musculoskeletal injuries and conditions for future studies
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Professor Andrew McCaskie, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Andrew McCaskie, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632563
- Sponsor's protocol ID
- A095310
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of participant level data does not fall within the consent or ethical approval of the study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Musculoskeletal Symptoms in the Cambridge NIHR BioResource
- ClinicalTrials.gov ID
- NCT04632563
- Acronym / sponsor ID
- A095310
- Conditions
- Musculoskeletal Diseases, Musculoskeletal Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- Nov 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 17 Nov 2020 (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.
Musculoskeletal diseases, such as osteoarthritis, represent a large proportion of the global burden of disease with hip and knee osteoarthritis alone being the 11th greatest cause of disease burden.
The purpose of this study is to determine the level of musculoskeletal symptoms in members of the Cambridge National Institute for Health Research (NIHR) BioResource and see if this is associated with their possession of genetic markers that have been identified as being associated with osteoarthritis.
This will allow us to determine the real level of musculoskeletal symptoms in this large cohort of volunteers and provide basic information that could be used to facilitate further musculoskeletal research in the NIHR BioResource population.
Detailed description
All active members of the Cambridge NIHR BioResource will be approached.
They will be sent an email outlining the purpose of the study and asking that if they would like to take part to please complete the online questionnaire which will be linked to in the email.
For those individuals who agree to participate and complete the questionnaire, the Cambridge NIHR BioResource will provide the genetic marker information it already holds for specific markers that are known to be associated with osteoarthritis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Member of BioResource | – | Other: Questionnaire including MSK-HQ (Musculoskeletal Health Questionnaire)Any BioResource member who consents to take part in the study and completes the study questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All members of the Cambridge NIHR BioResource
Key inclusion criteria (2 listed)
- Member of the NIHR BioResource
- Willing to consent to participate
Key exclusion criteria (1 listed)
- Previous self-report of osteoarthritis on joining BioResource
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire including MSK-HQ (Musculoskeletal Health Questionnaire)A questionnaire regarding musculoskeletal past medical history and current symptoms. | Other | Member of BioResource |
Primary outcome
MSK Symptom Levels
Time frame: 3 months
Musculoskeletal Symptoms in respondents
Osteoarthritis genetic marker
Time frame: 6 months
Possession (or not) of specific genetic markers for osteoarthritis (obtained from information already held by the NIHR BioResource)
1 secondary outcome
MSK Cohort
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No. Sharing of participant level data does not fall within the consent or ethical approval of the study.
Related trials for Musculoskeletal Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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.
Andrew McCaskie principal investigator
University of Cambridge
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases and Musculoskeletal Injury, run by Cambridge University Hospitals NHS Foundation Trust.
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 2 inclusion and 1 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Benjamin Davies (+44 1223 217551, bmd35@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSK Symptom Levels (time frame: 3 months). The study lists 2 primary outcomes in all. 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 17 Nov 2020.