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Understanding Pain Perception in Osteoarthritis (PAPO)

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ClinicalTrials.gov Identifier: NCT02603939
Recruitment Status : Recruiting
First Posted : November 13, 2015
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
St George's, University of London

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.

Condition or disease Intervention/treatment
Osteoarthritis Pain 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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Understanding Pain Perception in Osteoarthritis: a Mechanistic Study in People With Knee Osteoarthritis
Actual Study Start Date : June 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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



Primary Outcome Measures :
  1. Pain outcomes measured by Western Ontario and McMaster Universities Index (WOMAC) [ Time Frame: 1 Year after joint replacement ]
    Western Ontario and McMaster Universities Index (WOMAC)


Secondary Outcome Measures :
  1. Magnetic Resonance Imaging Knee Osteoarthritis Score [ Time Frame: Pre-operatively ]
    Level of tissue damage quantified by MOAKS scoring at baseline before joint surgery


Biospecimen Retention:   Samples With DNA
Blood collected


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
People with symptomatic knee osteoarthritis who are in pain and are being considered for joint replacement surgery
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


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): NCT02603939


Contacts
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Contact: Abiola Harrison, BSc 020 8266 6474 oharriso@sgul.ac.uk

Locations
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United Kingdom
Hotung Centre for Musculoskeletal Diseases Recruiting
London, United Kingdom, SW17 ORE
Contact: Lena Assi    020 8725 4220    lassi@sgul.ac.uk   
Sponsors and Collaborators
St George's, University of London
Investigators
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Principal Investigator: Nidhi Sofat, MBBS, PhD St George's, University of London
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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT02603939    
Other Study ID Numbers: 12.0056
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Keywords provided by St George's, University of London:
Pain
Magnetic resonance imaging
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases