Knee OsteoarthritisNCT06901921
Responsiveness and Minimal Clinically Important Difference (MCID) of Knee Injury and Osteoarthritis (KOOS-12) in (OA)
An observational study of Knee Osteoarthritis, run by Superior University at 1 site in Pakistan.
Trial summary
Osteoarthritis (OA) is a common and disabling constant Musculoskeletal Disorder that causes significant weight on individual, Health Care Systems, and social economy. With the maturing of the populace and the commonness of undesirable way of life practices, the predominance and disease burden of OA are expanding day… Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PT-intervention
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Osteoarthritis (OA) is a common and disabling constant Musculoskeletal Disorder that causes significant weight on individual, Health Care Systems, and social economy. With the maturing of the populace and the commonness of undesirable way of life practices, the predominance and disease burden of OA are expanding day by day. Different non-surgical interventions have been introduced worldwide for the treatment of knee OA. The aim of this study is to determine the responsiveness and minimal clinically important difference for knee injury and osteoarthritis outcome score-12 in knee OA patients respectively.
Who may be able to join
- An Age group of 50-65 years will be included in study.
- both males and females will be included.
- Patients with Unilateral knee OA with K-L grade II-III involving medial side will be a part of study.
- Following ACR (American college of rheumatology) guidelines Patient with knee pain must have 3 or more than 3 of the following symptoms i.e. age >50 years, morning stiffness <30 minutes, crepitus on movement, tenderness, bony enlargements, no palpable warmth will also be a part of study.
- patient having pain ranging from 5-8 on Numeral Pain Rating Scale (NPRS) will be included
Who cannot join
- participants with Traumatic knee injuries (cruciate injuries, meniscal injuries etc.) will be excluded.
- Osteonecrosis patients will be excluded.
- Patient with Neurological problems won't be a part of this study.
- People having Metastasis or neoplasm will be omitted.
- Knee or hip fractures
- Rheumatoid arthritis, Systemic lupus erythematosus (SLE) or other autoimmune disease people will be listed out.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Lahore, Punjab Province
About this study
Official title: Responsiveness and Minimal Clinically Important Difference (MCID) of Knee Injury and Osteoarthritis Outcome Score-12 (KOOS-12) in Patients With Knee Osteoarthritis (OA): A Prospective Cohort Study.
Osteoarthritis (OA) is a common and disabling constant Musculoskeletal Disorder that causes significant weight on individual, Health Care Systems, and social economy. With the maturing of the populace and the commonness of undesirable way of life practices, the predominance and disease burden of OA are expanding day by day. Different non-surgical interventions have been introduced worldwide for the treatment of knee OA. The aim of this study is to determine the responsiveness and minimal clinically important difference for knee injury and osteoarthritis outcome score-12 in knee OA patients respectively.
- Conditions
- Knee Osteoarthritis
- Being tested
- PT-intervention
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT-interventionDiagnostic test
60 participants undergoing PT-intervention for about 3 months will be taken and questionnaire (KOOS-12) will be filled by them at regular intervals of baseline, 4, 8 and 12 weeks respectively while global rating of change questionnaire will be filled by them at start and end of intervention and these values will be compared to see if patients' condition has improved or not.
| Study group | Role | What they receive |
|---|---|---|
| PT-intervention | Not described Receives: Diagnostic Test: PT-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and osteoarthritis outcome score-12 (KOOS-12)
It mainly consisted of 3 sub-parts having 12 questions that include Pain, Function, and QOL. No. of score for each item is from 0-4 and the mean score is 100 where 0 indicates dangerous practical difficulties and 100 indicates normality.
Scale Name:2.2.
Measured: 12 Months
GLOBAL RATING OF CHANGE (GRC) USING ANCHOR-BASED METHOD
This questionnaire will ask the participators to evaluate their present condition with their baseline condition. The scale consists of 15 points on it from -7 to 7, whereby -7 displays a very great deal worse, 0 symbols as remain same, and 7 reflects as a very great deal better. This is used to classify the members into the "change" group including points ±6-±7 points and "no change" group including 0-±5 points for evaluating MCID.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901921
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/780
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsiveness and Minimal Clinically Important Difference (MCID) of Knee Injury and Osteoarthritis Outcome Score-12 (KOOS-12) in Patients With Knee Osteoarthritis (OA): A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT06901921
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/780
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 30 Mar 2025 (actual)
- 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 common and disabling constant Musculoskeletal Disorder that causes significant weight on individual, Health Care Systems, and social economy. With the maturing of the populace and the commonness of undesirable way of life practices, the predominance and disease burden of OA are expanding day by day. Different non-surgical interventions have been introduced worldwide for the treatment of knee OA. The aim of this study is to determine the responsiveness and minimal clinically important difference for knee injury and osteoarthritis outcome score-12 in knee OA patients respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PT-intervention | – | Diagnostic Test: PT-intervention |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Osteoarthritis (OA) is a common and disabling constant Musculoskeletal Disorder that causes significant weight on individual, Health Care Systems, and social economy. With the maturing of the populace and the commonness of undesirable way of life practices, the predominance and disease burden of OA are expanding day by day. Different non-surgical interventions have been introduced worldwide for the treatment of knee OA. The aim of this study is to determine the responsiveness and minimal clinically important difference for knee injury and osteoarthritis outcome score-12 in knee OA patients respectively.
Key inclusion criteria (5 listed)
- An Age group of 50-65 years will be included in study.
- both males and females will be included.
- Patients with Unilateral knee OA with K-L grade II-III involving medial side will be a part of study.
- Following ACR (American college of rheumatology) guidelines Patient with knee pain must have 3 or more than 3 of the following symptoms i.e. age >50 years, morning stiffness <30 minutes, crepitus on movement, tenderness, bony enlargements, no palpable warmth will also be a part of study.
- patient having pain ranging from 5-8 on Numeral Pain Rating Scale (NPRS) will be included
Key exclusion criteria (6 listed)
- participants with Traumatic knee injuries (cruciate injuries, meniscal injuries etc.) will be excluded.
- Osteonecrosis patients will be excluded.
- Patient with Neurological problems won't be a part of this study.
- People having Metastasis or neoplasm will be omitted.
- Knee or hip fractures
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 |
|---|---|---|
| PT-intervention60 participants undergoing PT-intervention for about 3 months will be taken and questionnaire (KOOS-12) will be filled by them at regular intervals of baseline, 4, 8 and 12 weeks respectively while global rating of change questionnaire will be filled by them at start and end of intervention and these values will be compared to see if patients' condition has improved or not. | Diagnostic test | PT-intervention |
Primary outcome
Knee injury and osteoarthritis outcome score-12 (KOOS-12)
Time frame: 12 Months
It mainly consisted of 3 sub-parts having 12 questions that include Pain, Function, and QOL. No. of score for each item is from 0-4 and the mean score is 100 where 0 indicates dangerous practical difficulties and 100 indicates normality. Scale Name:2.2.
GLOBAL RATING OF CHANGE (GRC) USING ANCHOR-BASED METHOD
Time frame: 12 months
This questionnaire will ask the participators to evaluate their present condition with their baseline condition. The scale consists of 15 points on it from -7 to 7, whereby -7 displays a very great deal worse, 0 symbols as remain same, and 7 reflects as a very great deal better. This is used to classify the members into the "change" group including points ±6-±7 points and "no change" group including 0-±5 points for evaluating MCID.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Knee Osteoarthritis, run by Superior University at 1 site in Pakistan.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Knee injury and osteoarthritis outcome score-12 (KOOS-12) (time frame: 12 Months). 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?
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 30 Mar 2025.