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Estimation of the MCID for Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, mcid, exercise, rehabilitation

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Istinye University Physiotherapy and Rehabilitation Application and Research Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exercise

Arm Description

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

Outcomes

Primary Outcome Measures

WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index
KOOS
Knee Injury and Osteoarthritis Outcome Score
LEFS
Lower Extremity Functional Scale
Knee Range of Motion
Range of motion assessment with goniometer

Secondary Outcome Measures

30s sit to stand test
For functional assessment, patient sit and stand for 30 seconds

Full Information

First Posted
May 22, 2023
Last Updated
September 12, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT06034665
Brief Title
Estimation of the MCID for Patients With Knee Osteoarthritis
Official Title
Estimation of The Minimal Clinically Important Difference (MCID) for Commonly Used Outcome Measures in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, mcid, exercise, rehabilitation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Other
Arm Description
All patients will receive an exercise rehabilitation program tailored to their needs.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
All patients will be included in the exercise program for their symptoms regarding knee osteoarthritis for 15 sessions.
Primary Outcome Measure Information:
Title
WOMAC
Description
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame
Baseline, after 15 session and 4 months follow up
Title
KOOS
Description
Knee Injury and Osteoarthritis Outcome Score
Time Frame
Baseline, after 15 session and 4 months follow up
Title
LEFS
Description
Lower Extremity Functional Scale
Time Frame
Baseline, after 15 session and 4 months follow up
Title
Knee Range of Motion
Description
Range of motion assessment with goniometer
Time Frame
Baseline, after 15 session and 4 months follow up
Secondary Outcome Measure Information:
Title
30s sit to stand test
Description
For functional assessment, patient sit and stand for 30 seconds
Time Frame
Baseline, after 15 session and 4 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istinye University Physiotherapy and Rehabilitation Application and Research Center
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Estimation of the MCID for Patients With Knee Osteoarthritis

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