Knee Pain Phenotypes in the Community Study

Knee Osteoarthritis Clinical Trial

Official title:

Knee Pain and Related Health in the Community Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02098070
• Other study ID #: 14018
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 14, 2014
• Last updated: August 23, 2017
• Start date: September 2014
• Est. completion date: September 2018

Study information

• Verified date: August 2017
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 urine biomarkers.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40000
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion criteria:

• Aged 40 years and over

Exclusion criteria:

• Inability to give informed consent

• Terminal or mental illness

• Pregnant women

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
United Kingdom	Academic Rheumatology	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Arthritis Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to 12 months