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

NCT06901921 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall23/780
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Study Arms (1)

PT-intervention

Diagnostic Test: PT-intervention

Interventions

PT-intervention DIAGNOSTIC_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.

PT-intervention

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 30, 2025
• Study Start: March 20, 2025
• Primary Completion: June 20, 2025
• Study Completion: February 20, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)