Estimation of the MCID for Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06034665
• Other study ID #: DR2022
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 5, 2023

Study information

• Verified date: January 2024
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 5, 2023
• Est. primary completion date: June 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Turkey	Istinye University Physiotherapy and Rehabilitation Application and Research Center	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC	Western Ontario and McMaster Universities Osteoarthritis Index	Baseline, after 15 session and 4 months follow up
Primary	KOOS	Knee Injury and Osteoarthritis Outcome Score	Baseline, after 15 session and 4 months follow up
Primary	LEFS	Lower Extremity Functional Scale	Baseline, after 15 session and 4 months follow up
Primary	Knee Range of Motion	Range of motion assessment with goniometer	Baseline, after 15 session and 4 months follow up
Secondary	30s sit to stand test	For functional assessment, patient sit and stand for 30 seconds	Baseline, after 15 session and 4 months follow up