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

NCT ID: NCT06901921

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-02-20

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PT-intervention

PT-intervention

Intervention Type: 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.

Interventions

PT-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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall23/780

Identifier Type: -

Identifier Source: org_study_id