Estimation of the MCID for Patients With Knee Osteoarthritis

Sponsor

Istanbul University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06034665

Collaborator

(none)

100

Enrollment

Location

Arm

21.9

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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, KOOS, LEFS scales will be used also knee range of motion will be assessed in the baseline, after treatments, in the 4th and 6th months.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Other: Exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Exercise All patients will receive an exercise rehabilitation program tailored to their needs.	Other: Exercise All patients will be included in the exercise program for their symptoms regarding knee osteoarthritis for 15 sessions.

Arm

Intervention/Treatment

Other: Exercise

All patients will receive an exercise rehabilitation program tailored to their needs.

Other: Exercise

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

Outcome Measures

Primary Outcome Measures

WOMAC [Baseline, after 15 session and 4 months follow up]
Western Ontario and McMaster Universities Osteoarthritis Index
KOOS [Baseline, after 15 session and 4 months follow up]
Knee Injury and Osteoarthritis Outcome Score
LEFS [Baseline, after 15 session and 4 months follow up]
Lower Extremity Functional Scale
Knee Range of Motion [Baseline, after 15 session and 4 months follow up]
Range of motion assessment with goniometer

Secondary Outcome Measures

30s sit to stand test [Baseline, after 15 session and 4 months follow up]
For functional assessment, patient sit and stand for 30 seconds

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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