Clinical trial NCT02603939: Understanding Pain Perception in Osteoarthritis
Official title: Understanding Pain Perception in Osteoarthritis: a Mechanistic Study in People With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Pain
Keywords: Pain
Magnetic resonance imaging
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 250
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with symptomatic knee osteoarthritis who are in pain and are being considered for joint replacement surgery

Brief summary: Osteoarthritis (OA)is a painful and disabling disease, predicted to be the fourth largest cause of disability worldwide by 2020. It commonly affects the hip or knee ultimately resulting in total joint replacement. In order to assess disease progression and plan surgery, x-rays are taken as part of routine practice. However x-rays provide limited information about formation of substructures and changes occurring during progression of disease. The proposed study aims to invite patients with OA of the hip or knee to participate in detailed examinations of their pain and their painful joint through interviews, blood and urine samples taken, MRI magnetic resonance imaging)and donating their waste tissue after joint surgery (all of old joint). Informed patient consent will be sought in all cases.

Detailed description: The patient will be asked for permission for a clinician to access their notes for information relevant to the research, including full medical history, their sex and date of birth. Tissue obtained from joint replacement surgery at St. George's Hospital and transferred to St.George's, University of London where it will be prepared for various experiments including looking at the genes and proteins in people with osteoarthritis. The blood and urine samples will also be taken to St. George's, University of London, and prepared for studies on the genes and proteins in people with osteoarthritis. All samples provided will be anonymised with no patient details on the samples and stored in locked freezers, in locked labs. at St.George's, University of London.

Eligibility criteria: Inclusion criteria:

Inclusion Criteria for OA patients:

Study participant will be recruited from rheumatology outpatient clinics and primary care:

1. fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
2. male or female,
3. symptomatic knee pain
4. on usual care for knee osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
5. participants between 35 and 90 who will be undergoing knee replacement surgery or arthroscopy for osteoarthritis or knee surgery for fractured tibia/femur/fibula with osteoarthritis

Inclusion criteria for Early OA Patients

Study participant will be recruited from rheumatology outpatient clinics and primary care:

1. fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
2. male or female,
3. symptomatic knee pain
4. on usual care for knee osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
5. Participants between 35 and 90 who have osteoarthritis but will not be undergoing knee surgery

Inclusion criteria for Healthy control subjects

1. Participants aged between 35 and 90 who do not have knee pain or osteoarthritis as a comparator group

Primary outcomes:
measure: Pain outcomes measured by Western Ontario and McMaster Universities Index (WOMAC)
timeFrame: 1 Year after joint replacement
Secondary outcomes:
measure: Magnetic Resonance Imaging Knee Osteoarthritis Score
timeFrame: Pre-operatively
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hotung Centre for Musculoskeletal Diseases
Study officials:
affiliation: St George's, University of London
name: Nidhi Sofat, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: