Estimation of the MCID for Patients With Knee Osteoarthritis

January 7, 2024 updated by: Derya Celik, Istanbul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istinye University Physiotherapy and Rehabilitation Application and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30s sit to stand test
Time Frame: Baseline, after 15 session and 4 months follow up
For functional assessment, patient sit and stand for 30 seconds
Baseline, after 15 session and 4 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

June 4, 2023

Study Completion (Actual)

December 5, 2023

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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