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

Active, not recruiting

• Conditions: Knee Osteoarthritis

• Registration Number: NCT06901921
• Lead Sponsor: Superior University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-20
• Study First Submitted: 2025-03-23
• Study First Submitted QC: 2025-03-23
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-06-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GLOBAL RATING OF CHANGE (GRC) USING ANCHOR-BASED METHOD	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.
Knee injury and osteoarthritis outcome score-12 (KOOS-12)	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.

Trial Locations

Locations (1)

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University; 🇵🇰 Lahore, Punjab, Pakistan