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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06447142
Other study ID # 2133
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 10, 2024
Est. completion date October 10, 2024

Study information

Verified date June 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact Tansu Birinci, PT, PhD
Phone 02162803333
Email tansubirinci@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized-controlled trial aims to compare the effect of open kinetic chain and closed kinetic chain strengthening exercises on pain, function, and health-related quality of life in degenerative meniscus tears.


Description:

Patients with degenerative meniscus tears between the ages of 40 and 65 will be randomly divided into two groups: Group 1 (open kinetic chain strengthening exercises) and Group 2 (closed kinetic chain strengthening exercises). Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline and at the end of the 8-week intervention. The pain during activity, at rest, and at night will be assessed with the Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status and symptoms will be evaluated by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Scoring Scale. Health-related quality of life will be assessed with the Short Form-12 (SF-12).


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date October 10, 2024
Est. primary completion date August 10, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - Being aged between 40 and 65 years - Having the degenerative meniscus tear in at least one knee - Having body mass index in the range of 18-30 kg/m2 - Feeling the pain that lasts for at least 2 months - Having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the MRI results - Having the ability to read and write Turkish Exclusion Criteria: - Having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear - Participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks - Have received steroid injections in the last 6 months - Accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis - Presence of any systemic disorder that may affect assessment parameters - Failure to cooperate with assessments

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Open kinetic chain strengthening exercise
A web-based 8-week exercise program consisting of stretching exercises, open kinetic chain strengthening exercises, and functional exercises for the knee and hip will be performed.
Closed kinetic chain strengthening exercise
A web-based 8-week exercise program consisting of stretching exercises, closed kinetic chain strengthening exercises, and functional exercises for the knee and hip will be performed.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul Bakirkoy

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee Injury and Osteoarthritis Outcome Score (KOOS) Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. Baseline
Secondary Knee Injury and Osteoarthritis Outcome Score (KOOS) Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. At the end of 8-week intervention
Secondary Visual Analogue Scale (VAS) Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain. Baseline
Secondary Visual Analogue Scale (VAS) Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain. At the end of 8-week intervention
Secondary Active Range of Motion Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer. Baseline
Secondary Active Range of Motion Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer. At the end of 8-week intervention
Secondary Muscle Strength Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded. Baseline
Secondary Muscle Strength Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded. At the end of the 8-week intervention
Secondary Lysholm Score Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability. Baseline
Secondary Lysholm Score Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability. At the end of the 8-week intervention
Secondary Short Form-12 (SF-12) Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life. Baseline
Secondary Short Form-12 (SF-12) Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life. At the end of the 8-week intervention
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