Meniscus Tear Clinical Trial
Official title:
Investigation of the Efficacy of Video-Based Exercise Programs in Degenerative Meniscus Tears
Verified date | June 2024 |
Source | Istanbul University - Cerrahpasa (IUC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized-controlled trial aims to investigate the efficacy of video-based exercise programs with face-to-face or remote supervision in patients with degenerative meniscus tears.
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | July 1, 2024 |
Est. primary completion date | November 30, 2022 |
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 activity level is between 1 and 5 according to the Tegner Activity Scale - 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 - Any vision or hearing problem that would prevent them from adapting to the assessment |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University-Cerrahpasa | Istanbul | Bakirkoy |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
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. | After 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 | Western Ontario Meniscal Evaluation Tool (WOMET) | The health-related quality of life related to degenerative meniscal tear will be used with the WOMET, which is a disease-specific tool designed to evaluate health-related quality of life in patients with meniscal pathology. The WOMET contains sixteen items addressing three domains: nine items addressing physical symptoms; four items addressing disabilities due to sports, recreation, work, and lifestyle; and three items addressing emotions. The best and least symptomatic score is 0, and the highest and most symptomatic score possible is 1600. | Baseline | |
Secondary | Western Ontario Meniscal Evaluation Tool (WOMET) | The health-related quality of life related to degenerative meniscal tear will be used with the WOMET, which is a disease-specific tool designed to evaluate health-related quality of life in patients with meniscal pathology. The WOMET contains sixteen items addressing three domains: nine items addressing physical symptoms; four items addressing disabilities due to sports, recreation, work, and lifestyle; and three items addressing emotions. The best and least symptomatic score is 0, and the highest and most symptomatic score possible is 1600. | At the end of the 8-week intervention |
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