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Measures of Pain Relevant to Knee Osteoarthritis

This study is currently recruiting participants.
Verified October 2012 by University of Nottingham
Sponsor:
Collaborator:
Arthritis Research Campaign
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01310257
First received: March 2, 2011
Last updated: October 4, 2012
Last verified: October 2012
History of Changes

March 2, 2011
October 4, 2012
December 2010
December 2012   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01310257 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Pain and sensory thresholds will be reported for the affected area (i.e., OA knee) and control areas (e.g., healthy contralateral knee).
Quantitative Sensory Testing assessing pain and sensory thresholds for a noxious stimulus (e.g., heat). [ 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. ] [ Designated as safety issue: No ]
Pain and sensory thresholds will be reported for the affected area (i.e., OA knee) and a control area (e.g., healthy contralateral knee).
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Measures of Pain Relevant to Knee Osteoarthritis
Evaluation of Questionnaire Measures for Patients With Osteoarthritis of the Knee

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.
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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

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)
Osteoarthritis of the Knee
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.
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.
Intervention: Other: Questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bryan J Moreton, PhD 0115 846 6545 bryan.moreton@nottingham.ac.uk
United Kingdom
 
NCT01310257
10052, 9227
No
University of Nottingham
University of Nottingham
Arthritis Research Campaign
Principal Investigator: Bryan Moreton University of Nottingham
University of Nottingham
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP