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Estimation of the MCID for Patients With Knee Osteoarthritis

Estimation of The Minimal Clinically Important Difference (MCID) for Commonly Used Outcome Measures in Patients With Knee Osteoarthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06034665
Enrollment
94
Registered
2023-09-13
Start date
2022-02-01
Completion date
2023-12-05
Last updated
2024-01-09

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

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis, mcid, exercise, rehabilitation

Brief summary

Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these scales are needed to understand the change in patients after treatment and to manage the treatment. It is also one of the most important data in calculating the MCID sample size. Aim: In the literature, MCID studies for exercise applied to knee OA are limited especially for those who did not undergo surgery. Thus new studies are needed. Method: 100 patients who were diagnosed with knee osteoarthritis will be recruited for the study. Participants will be included in an exercise program tailored to their needs for 15 sessions. WOMAC, OKS, LEFS scales will be used also knee range of motion will be assessed in the baseline, after treatments and in the 4th month follow up.

Interventions

OTHERExercise

All patients will be included in the exercise program for their symptoms regarding knee osteoarthritis for 15 sessions.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* To be diagnosed with knee OA according to the criteria of the American Society of Rheumatology (ACR) (Diagnosis of primary knee OA) * Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria * Participants with age between 50 and 70 years old * Being able to walk without using an assistive device * Having a body mass index of less than 30 kg/m² * Pain severity is between 3 and 7 according to the Numerical Pain Rating Scale

Exclusion criteria

* Patients who received physical therapy or intra-articular injections in the last 6 months * Receiving an indication for surgery * Have severe hearing, vision and speech impairment * Having serious systemic and cardiovascular diseases that interfere with exercise * Having a lower extremity deformity * Patients with acute inflammation of the knee

Design outcomes

Primary

MeasureTime frameDescription
WOMACBaseline, after 15 session and 4 months follow upWestern Ontario and McMaster Universities Osteoarthritis Index
KOOSBaseline, after 15 session and 4 months follow upKnee Injury and Osteoarthritis Outcome Score
LEFSBaseline, after 15 session and 4 months follow upLower Extremity Functional Scale
Knee Range of MotionBaseline, after 15 session and 4 months follow upRange of motion assessment with goniometer

Secondary

MeasureTime frameDescription
30s sit to stand testBaseline, after 15 session and 4 months follow upFor functional assessment, patient sit and stand for 30 seconds

Countries

Turkey (Türkiye)

Outcome results

None listed

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