Knee Pain Phenotypes in the Community Study

August 23, 2017 updated by: University of Nottingham

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

40000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Academic Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Community-derived sample

Description

Inclusion criteria:

  • Aged 40 years and over

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other Risk Factors
Time Frame: up to 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

Arthritis Research UK

Investigators

  • Principal Investigator: Michael Doherty, MD, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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