OsteoarthritisSORTNCT01294696
Survey of Osteoarthritis Real World Therapies (MK-0663-140)
An observational study of Osteoarthritis, run by Organon and Co.
Trial summary
This was a study to estimate the proportion of participants with osteoarthritis of the knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did not report adequate pain relief at Baseline and to characterize their pain level over a 12-month follow-up period. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 1,261 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Jan 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who are presently receiving prescribed oral or topical analgesics which commenced at least two weeks prior to enrollment
Who may be able to join
- Clinical diagnosis of primary osteoarthritis of the knee(s)
- Presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment
Who cannot join
- Arthritis other than primary osteoarthritis
- Treatment with disease-modifying antirheumatic drugs (DMARDS), methotrexate or biologics
- Subtotal or total joint replacement in the affected knee
- Chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study
- Currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days
About this study
Official title: Survey of Osteoarthritis Real World Therapies (SORT)
This was a study to estimate the proportion of participants with osteoarthritis of the knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did not report adequate pain relief at Baseline and to characterize their pain level over a 12-month follow-up period.
- Conditions
- Osteoarthritis
- Being tested
- Standard of care for treatment of osteoarthritis (OA) of knee(s)
- Keywords
- Osteoarthritis, Standard of care
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care for treatment of osteoarthritis (OA) of knee(s)Drug
All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician.
| Study group | Role | What they receive |
|---|---|---|
| All Enrolled Participants | All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician. Receives: Drug: Standard of care for treatment of osteoarthritis (OA) of knee(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline
Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).
Measured: Baseline (Day 1)
Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12
Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).
Measured: Month 12
Secondary outcomes (6)
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)
Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Measured: Baseline (Day 1)
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1
Joint stiffness or limitation in physical function was evaluated using the Western Ontario McMaster Osteoarthritis (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Measured: Month 1
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3
Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Measured: Month 3
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6
Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Measured: Month 6
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9
Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Measured: Month 9
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12
Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294696
- Sponsor's protocol ID
- 0663-140
- Acronym
- SORT
- Status last verified
- Feb 2022
- First submitted
- 22 Dec 2010
- Last updated
- 29 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Conaghan PG, Peloso PM, Everett SV, Rajagopalan S, Black CM, Mavros P, Arden NK, Phillips CJ, Rannou F, van de Laar MA, Moore RA, Taylor SD. Inadequate pain relief and large functional loss among patients with knee osteoarthritis: evidence from a prospective multinational longitudinal study of osteoarthritis real-world therapies. Rheumatology (Oxford). 2015 Feb;54(2):270-7. doi: 10.1093/rheumatology/keu332. Epub 2014 Aug 23.
PubMed 25150513
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Osteoarthritis Real World Therapies (SORT)
- ClinicalTrials.gov ID
- NCT01294696
- Acronym / sponsor ID
- SORT / 0663-140
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Standard of care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,261 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 4 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a study to estimate the proportion of participants with osteoarthritis of the knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did not report adequate pain relief at Baseline and to characterize their pain level over a 12-month follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Enrolled Participants | – | Drug: Standard of care for treatment of osteoarthritis (OA) of knee(s)All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who are presently receiving prescribed oral or topical analgesics which commenced at least two weeks prior to enrollment
Key inclusion criteria (2 listed)
- Clinical diagnosis of primary osteoarthritis of the knee(s)
- Presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment
Key exclusion criteria (5 listed)
- Arthritis other than primary osteoarthritis
- Treatment with disease-modifying antirheumatic drugs (DMARDS), methotrexate or biologics
- Subtotal or total joint replacement in the affected knee
- Chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study
- Currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days
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 |
|---|---|---|
| Standard of care for treatment of osteoarthritis (OA) of knee(s)All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician. | Drug | All Enrolled Participants |
Primary outcome
Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline
Time frame: Baseline (Day 1)
Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).
Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12
Time frame: Month 12
Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).
6 secondary outcomes
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)
Time frame: Baseline (Day 1)
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1
Time frame: Month 1
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3
Time frame: Month 3
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6
Time frame: Month 6
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9
Time frame: Month 9
Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25150513Conaghan PG, Peloso PM, Everett SV, Rajagopalan S, Black CM, Mavros P, Arden NK, Phillips CJ, Rannou F, van de Laar MA, Moore RA, Taylor SD. Inadequate pain relief and large functional loss among patients with knee osteoarthritis: evidence from a prospective multinational longitudinal study of osteoarthritis real-world therapies. Rheumatology (Oxford). 2015 Feb;54(2):270-7. doi: 10.1093/rheumatology/keu332. Epub 2014 Aug 23.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Organon and Co.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 4 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline (time frame: Baseline (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01294696, which also lists 1 linked publication.
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 29 Aug 2024.