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Completed

NCT Number: NCT06034665

Estimation of the MCID for 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istinye University Physiotherapy and Rehabilitation Application and Research Center

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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

Primary outcomes

  1. WOMAC

    Time frame: Baseline, after 15 session and 4 months follow up

    Western Ontario and McMaster Universities Osteoarthritis Index

  2. KOOS

    Time frame: Baseline, after 15 session and 4 months follow up

    Knee Injury and Osteoarthritis Outcome Score

  3. LEFS

    Time frame: Baseline, after 15 session and 4 months follow up

    Lower Extremity Functional Scale

  4. Knee Range of Motion

    Time frame: Baseline, after 15 session and 4 months follow up

    Range of motion assessment with goniometer

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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