Estimation of the MCID for Patients With Knee Osteoarthritis

Istanbul University

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06034665

DR2022

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

94 participants in 1 patient group

Exercise

Other group

Description:

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

Treatment:

Other: Exercise