OsteoarthritisPAPONCT02603939
Understanding Pain Perception in Osteoarthritis
An observational study of Osteoarthritis and Pain, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Pain
- What is being tested?
- Joint replacement surgery
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with symptomatic knee osteoarthritis who are in pain and are being considered for joint replacement surgery
Who may be able to join
- Study participant will be recruited from rheumatology outpatient clinics and primary care:
- fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
- male or female,
- symptomatic knee pain
- on usual care for knee osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
- 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
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- Study participant will be recruited from rheumatology outpatient clinics and primary care:
- fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
- male or female,
- symptomatic knee pain
- on usual care for knee osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
- Participants between 35 and 90 who have osteoarthritis but will not be undergoing knee surgery
- 1. Participants aged between 35 and 90 who do not have knee pain or osteoarthritis as a comparator group
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hotung Centre for Musculoskeletal Diseases
London, SW17 ORE
Lena Assi, 020 8725 4220, lassi@sgul.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Pain
- Being tested
- Joint replacement surgery
- Keywords
- Pain, Magnetic resonance imaging
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint replacement surgeryProcedure or surgery
We are assessing pain responses in participants with osteoarthritis before an after joint replacement surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: 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 being measured
The primary outcome is the main question the study is designed to answer.
Pain outcomes measured by Western Ontario and McMaster Universities Index (WOMAC)
Western Ontario and McMaster Universities Index (WOMAC)
Measured: 1 Year after joint replacement
Secondary outcomes (1)
Magnetic Resonance Imaging Knee Osteoarthritis Score
Level of tissue damage quantified by MOAKS scoring at baseline before joint surgery
Measured: Pre-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startJun 2013
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nidhi Sofat, MBBS, PhD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603939
- Sponsor's protocol ID
- 12.0056
- Acronym
- PAPO
- Status last verified
- Oct 2020
- First submitted
- 10 Nov 2015
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Pain Perception in Osteoarthritis: a Mechanistic Study in People With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02603939
- Acronym / sponsor ID
- PAPO / 12.0056
- Conditions
- Osteoarthritis, Pain
- Keywords
- Pain, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Advanced Knee OA | – | Procedure: Joint replacement surgeryPeople with advanced knee osteoarthritis requiring joint replacement surgery are being assessed for their pain responses before and 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 |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with symptomatic knee osteoarthritis who are in pain and are being considered for joint replacement surgery
Key inclusion criteria (13 listed)
- Study participant will be recruited from rheumatology outpatient clinics and primary care:
- fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis
- male or female,
- symptomatic knee pain
- on usual care for knee osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint replacement surgeryWe are assessing pain responses in participants with osteoarthritis before an after joint replacement surgery | Procedure or surgery | Participants with Advanced Knee OA |
Primary outcome
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)
1 secondary outcome
Magnetic Resonance Imaging Knee Osteoarthritis Score
Time frame: Pre-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nidhi Sofat, MBBS, PhD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Pain, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abiola Harrison, BSc (020 8266 6474, oharriso@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain outcomes measured by Western Ontario and McMaster Universities Index (WOMAC) (time frame: 1 Year after joint replacement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020; AzTrials last refreshed its copy on 4 Nov 2026.