NCT02098070

Brief 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 urine biomarkers.

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
40,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

March 14, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

4 years

First QC Date

March 14, 2014

Last Update Submit

August 23, 2017

Conditions

Keywords

Knee PainCommunity StudyKnee OsteoarthritisRisk Factors

Outcome Measures

Primary Outcomes (1)

  • 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).

    up to 12 months

Secondary Outcomes (1)

  • Other Risk Factors

    up to 12 months

Study Arms (2)

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.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community-derived sample

You may qualify if:

  • Aged 40 years and over

You may not qualify if:

  • Inability to give informed consent
  • Terminal or mental illness
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Rheumatology

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Related Publications (4)

  • 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.

  • Fernandes 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.

  • Fernandes 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.

  • Fernandes 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.

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood Urine

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael Doherty, MD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 27, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 24, 2017

Record last verified: 2017-08

Locations