Knee OsteoarthritisNCT02098070
Knee Pain Phenotypes in the Community Study
An observational study of Knee Osteoarthritis, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The focus of the study is to determine the prevalence and variance of self-reported knee pain characteristics in a community-derived sample of adults aged 40 years and over. It will also identify characteristics such as structural changes of osteoarthritis of the knee as well as physiological parameters and blood and… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 40,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Sep 2018
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-derived sample
Who may be able to join
- Aged 40 years and over
Who cannot join
- Inability to give informed consent
- Terminal or mental illness
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Rheumatology
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: Knee Pain and Related Health in the Community Study
The focus of the study is to determine the prevalence and variance of self-reported knee pain characteristics in a community-derived sample of adults aged 40 years and over. It will also identify characteristics such as structural changes of osteoarthritis of the knee as well as physiological parameters and blood and urine biomarkers.
Read the detailed description
Number of participants:
Part I: questionnaire to 40,000 people aged 40 years and over (giving an expected 10,000 respondents) Part II: 400 participants.
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Pain, Community Study, Knee Osteoarthritis, Risk Factors
- Medical subject headings
- Osteoarthritis, Knee
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 |
|---|---|---|
| Knee Pain Population | Participants who have responded to the questionnaire with self-reported pain. | |
| Non-Knee Pain Population | Participants who have responded to the questionnaire, no self-reported pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Pain Phenotypes
The prevalence of the different knee pain phenotypes, provided by specific pain questionnaires. This will include the Intermittent and Constant Osteoarthritis Pain Questionnaire (ICOAP), the Pain Catastrophizing Scale (PCS) and the PainDetect (for neuropathic pain).
Measured: up to 12 months
Secondary outcomes (1)
Other Risk Factors
The risk factors for each knee pain phenotype, including age, gender, pain elsewhere, the Hospital Anxiety and Depression Scale (HADS), the pain catastrophizing scale and presence of osteoarthritis risk factors (BMI, finger ratio (2D4D), finger nodes, knee alignment) will be determined from the questionnaires.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research UK
- Responsible party
- Sponsor
- Investigators
- Michael Doherty, MD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098070
- Sponsor's protocol ID
- 14018
- Status last verified
- Aug 2017
- First submitted
- 14 Mar 2014
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Swain S, Fernandes GS, Sarmanova A, Valdes AM, Walsh DA, Coupland C, Doherty M, Zhang W. Comorbidities and use of analgesics in people with knee pain: a study in the Nottingham Knee Pain and Health in the Community (KPIC) cohort. Rheumatol Adv Pract. 2022 Jun 15;6(2):rkac049. doi: 10.1093/rap/rkac049. eCollection 2022.
PubMed 35784017Fernandes GS, Parekh SM, Moses J, Fuller CW, Scammell B, Batt ME, Zhang W, Doherty M. Depressive symptoms and the general health of retired professional footballers compared with the general population in the UK: a case-control study. BMJ Open. 2019 Sep 8;9(9):e030056. doi: 10.1136/bmjopen-2019-030056.
PubMed 31501119Fernandes GS, Valdes AM, Walsh DA, Zhang W, Doherty M. Neuropathic-like knee pain and associated risk factors: a cross-sectional study in a UK community sample. Arthritis Res Ther. 2018 Sep 27;20(1):215. doi: 10.1186/s13075-018-1717-6.
PubMed 30261907Fernandes GS, Sarmanova A, Warner S, Harvey H, Akin-Akinyosoye K, Richardson H, Frowd N, Marshall L, Stocks J, Hall M, Valdes AM, Walsh D, Zhang W, Doherty M. Knee pain and related health in the community study (KPIC): a cohort study protocol. BMC Musculoskelet Disord. 2017 Sep 21;18(1):404. doi: 10.1186/s12891-017-1761-4.
PubMed 28934932
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Pain and Related Health in the Community Study
- ClinicalTrials.gov ID
- NCT02098070
- Acronym / sponsor ID
- 14018
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Pain, Community Study, Knee Osteoarthritis, Risk Factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Arthritis Research UK
- Study start
- Sep 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Mar 2014 (estimated)
- 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.
The focus of the study is to determine the prevalence and variance of self-reported knee pain characteristics in a community-derived sample of adults aged 40 years and over. It will also identify characteristics such as structural changes of osteoarthritis of the knee as well as physiological parameters and blood and urine biomarkers.
Detailed description
Number of participants:
Part I: questionnaire to 40,000 people aged 40 years and over (giving an expected 10,000 respondents) Part II: 400 participants.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee Pain Population | – | –Participants who have responded to the questionnaire with self-reported pain. |
| Non-Knee Pain Population | – | –Participants who have responded to the questionnaire, no self-reported pain. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-derived sample
Key inclusion criteria (1 listed)
- Aged 40 years and over
Key exclusion criteria (3 listed)
- Inability to give informed consent
- Terminal or mental illness
- Pregnant women
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
Knee Pain Phenotypes
Time frame: up to 12 months
The prevalence of the different knee pain phenotypes, provided by specific pain questionnaires. This will include the Intermittent and Constant Osteoarthritis Pain Questionnaire (ICOAP), the Pain Catastrophizing Scale (PCS) and the PainDetect (for neuropathic pain).
1 secondary outcome
Other Risk Factors
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Derived from this study: PubMed 35784017Swain S, Fernandes GS, Sarmanova A, Valdes AM, Walsh DA, Coupland C, Doherty M, Zhang W. Comorbidities and use of analgesics in people with knee pain: a study in the Nottingham Knee Pain and Health in the Community (KPIC) cohort. Rheumatol Adv Pract. 2022 Jun 15;6(2):rkac049. doi: 10.1093/rap/rkac049. eCollection 2022.
- Derived from this study: PubMed 31501119Fernandes GS, Parekh SM, Moses J, Fuller CW, Scammell B, Batt ME, Zhang W, Doherty M. Depressive symptoms and the general health of retired professional footballers compared with the general population in the UK: a case-control study. BMJ Open. 2019 Sep 8;9(9):e030056. doi: 10.1136/bmjopen-2019-030056.
- Derived from this study: PubMed 30261907Fernandes GS, Valdes AM, Walsh DA, Zhang W, Doherty M. Neuropathic-like knee pain and associated risk factors: a cross-sectional study in a UK community sample. Arthritis Res Ther. 2018 Sep 27;20(1):215. doi: 10.1186/s13075-018-1717-6.
- Derived from this study: PubMed 28934932Fernandes GS, Sarmanova A, Warner S, Harvey H, Akin-Akinyosoye K, Richardson H, Frowd N, Marshall L, Stocks J, Hall M, Valdes AM, Walsh D, Zhang W, Doherty M. Knee pain and related health in the community study (KPIC): a cohort study protocol. BMC Musculoskelet Disord. 2017 Sep 21;18(1):404. doi: 10.1186/s12891-017-1761-4.
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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.
Michael Doherty, MD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by University of Nottingham at 1 site 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 1 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 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain Phenotypes (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098070, which also lists 4 linked publications.
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 24 Aug 2017.