Understanding Pain Perception in Osteoarthritis (PAPO)

Understanding Pain Perception in Osteoarthritis: a Mechanistic Study in People With Knee Osteoarthritis

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Osteoarthritis
• Intervention / Treatment: Procedure: Joint replacement surgery

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.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW17 ORE
    • Recruiting
    • Hotung Centre for Musculoskeletal Diseases
    • Contact: Lena Assi; Phone Number: 020 8725 4220; Email: lassi@sgul.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People with symptomatic knee osteoarthritis who are in pain and are being considered for joint replacement surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with Advanced Knee OA; People with advanced knee osteoarthritis requiring joint replacement surgery are being assessed for their pain responses before and after joint replacement surgery	Procedure: Joint replacement surgery; We are assessing pain responses in participants with osteoarthritis before an after joint replacement surgery
Participants with Early Knee OA; Participants with osteoarthritis with early disease who do not require joint replacement surgery are being assessed for pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain outcomes measured by Western Ontario and McMaster Universities Index (WOMAC)	Western Ontario and McMaster Universities Index (WOMAC)	1 Year after joint replacement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Imaging Knee Osteoarthritis Score	Level of tissue damage quantified by MOAKS scoring at baseline before joint surgery	Pre-operatively

Collaborators and Investigators

• Sponsor: St George's, University of London
• Investigators: Principal Investigator: Nidhi Sofat, MBBS, PhD, St George's, University of London

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Magnetic resonance imaging
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 12.0056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No