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Measures of Pain Relevant to Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310257
First Posted: March 8, 2011
Last Update Posted: January 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Arthritis Research UK
Information provided by (Responsible Party):
University of Nottingham
  Purpose
The aim is to improve understanding of the assessment of pain experience in patients with osteoarthritis (OA) of the knee. The current study will be divided into two parts. In Study 1, the investigators will analyse existing questionnaires relevant to the mechanisms and therapeutic targets of knee OA to establish discrete dimensions that discriminate between the different mechanisms of pain. On the basis of this analysis, the investigators will refine the questionnaires to maximise their sensitivity to knee OA. In Study 2, the investigators will seek to confirm the factor structure identified in the questionnaires in Study 1 and explore potential mediator and moderator variables between pain and quality of life using the refined measures. The investigators will also evaluate Quantitative Sensory Testing as a predictor of OA knee pain.

Condition Intervention
Osteoarthritis of the Knee Other: Questionnaires

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Questionnaire Measures for Patients With Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Questionnaire set assessing physical symptoms, cognitive and emotional factors, and quality of life in knee OA. [ Time Frame: Patients will be assessed after diagnosis of OA of the knee. There is no specific time point after diagnosis, because we are interested in a broad spectrum of patients with OA of the knee. All patients will be assessed at enrollment into the study. ]
    Patients will be given a questionnaire set assessing pain (nociceptive and neuropathic), anxiety, depression, fatigue, illness belief, pain self-efficacy, coping, helplessness and quality of life, associated with OA of the knee. The psychometric properties of the questionnaire set will be reported, including results from Rasch Analysis, Cronbach's Alpha and results from Factor Analysis.


Secondary Outcome Measures:
  • Quantitative Sensory Testing assessing pain and sensory thresholds for a noxious stimulus (Pain Pressure Thresholds) [ Time Frame: Patients will be assessed after diagnosis of OA of the knee. There is no specific time point after diagnosis, because we are interested in a broad spectrum of patients with OA of the knee. ]
    Pain and sensory thresholds will be reported for the affected area (i.e., OA knee) and control areas (e.g., healthy contralateral knee).


Enrollment: 448
Study Start Date: December 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Knee osteoarthritis
Patients will have osteoarthritis (OA) of the knee defined and scored radiologically in Study 1. Patients in Study 2 will also have OA of the knee, but a clinical diagnosis will suffice. All patients will report knee pain.
Other: Questionnaires
Patients will be given questionnaires relevant to their condition to complete. In Study 2 and a sub-study of Study 1, patients will be invited to take part in Quantitative Sensory Testing.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We aim to recruit a cross section of participants covering a broad spectrum of people with OA of the knee. Community participants will be identified from a cohort of patients who have already agreed to be contacted about future research studies. Additional participants will be identified from clinics at Nottingham University Hospitals and Sherwood Forest Hospitals NHS Foundation Trust, GP surgeries in the local area and patients on a knee OA pathway from Nottingham Healthcare partnership. These sources of recruitment will include those attended rheumatology and orthopaedic specialist clinics for knee OA and rheumatology outpatients at the Queens Medical Centre (QMC)
Criteria

Inclusion Criteria:

  • Participants in Study 1 will have OA of the knee defined and scored radiologically and will report knee pain. Participants in Study 2 will also have OA of the knee, but a clinical diagnosis will suffice.

Exclusion Criteria:

  • Inability to speak or understand English
  • Under the age of 18 years old
  • knee joint surgery within three months prior to participation
  • Diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Gout or any other inflammatory arthritis disorder
  • The participants in Study 2 will also be excluded if they participated in Study 1
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310257


Locations
United Kingdom
Nottingham Country Health Partnerships
Nottingham, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Sherwood Forest Hospitals NHS Trust
Nottingham, United Kingdom
Sponsors and Collaborators
University of Nottingham
Arthritis Research UK
Investigators
Principal Investigator: Bryan Moreton University of Nottingham
  More Information

Additional Information:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01310257     History of Changes
Other Study ID Numbers: 10052
9227 ( Registry Identifier: UKCRN )
First Submitted: March 2, 2011
First Posted: March 8, 2011
Last Update Posted: January 17, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases