Measures of Pain Relevant to Knee Osteoarthritis

NCT01310257 | Completed

• 2 other identifiers: 100529227
• Study Type: observational
• Target: 448
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• Questionnaire set assessing physical symptoms, cognitive and emotional factors, and quality of life in knee OA.

  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.

  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.

Secondary Outcomes (1)

• Quantitative Sensory Testing assessing pain and sensory thresholds for a noxious stimulus (Pain Pressure Thresholds)

  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.

Study Arms (1)

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

Interventions

Questionnaires OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Arthritis Research UK: collaborator

Study Sites (3)

Nottingham Country Health Partnerships

Nottingham, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Sherwood Forest Hospitals NHS Trust

Nottingham, United Kingdom

Location

Related Links

• Arthritis Research UK Pain Centre

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Bryan Moreton

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 8, 2011
• Study Start: December 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

GB (3)