Clinical trial NCT06901921: Responsiveness and Minimal Clinically Important Difference (MCID) of Knee Injury and Osteoarthritis (KOOS-12) in (OA)
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.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Osteoarthritis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Knee injury and osteoarthritis outcome score-12 (KOOS-12)
timeFrame: 12 Months
measure: GLOBAL RATING OF CHANGE (GRC) USING ANCHOR-BASED METHOD
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
state: Punjab
Study officials:
References: