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Responsiveness and Minimal Clinically Important Difference (MCID) of Knee Injury and Osteoarthritis (KOOS-12) in (OA)

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06901921
Enrollment
60
Registered
2025-03-30
Start date
2025-03-20
Completion date
2026-02-20
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

DIAGNOSTIC_TESTPT-intervention

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.

Sponsors

Superior University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Knee injury and osteoarthritis outcome score-12 (KOOS-12)12 MonthsIt 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 METHOD12 monthsThis 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026