The Video-Based Exercise Programs in Degenerative Meniscus Tears

Meniscus Tear Clinical Trial

Official title:

Investigation of the Efficacy of Video-Based Exercise Programs in Degenerative Meniscus Tears

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05266365
• Other study ID #: 107
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: June 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

To investigate the efficacy of a video-based exercise programs, voluntary patients with degenerative meniscus tears, aged between 40 and 65 years, will be randomly divided into two groups: the face-to-face supervised video-based exercise (FVBE) group and the remote supervised video-based exercise (RVBE) group. 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). Health-related quality of life will be assessed with the Western Ontario Meniscal Evaluation Tool (WOMET).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Degenerative Disease
• Knee Pain Swelling
• Meniscus Tear

Intervention

Other:
• The face-to-face supervised video-based exercise (FVBE) group
An 8-week exercise program used in conservative treatment of degenerative meniscus tears will be performed. The physiotherapist will create a video record for the patients that will include a detailed description of each exercise. This video recording will be watched in the clinic, and the patients will do video-based exercises by following the instructions in the video.
• The remote supervised video-based exercise group (RVBE)
An 8-week exercise program used in conservative treatment of degenerative meniscus tears will be performed. The physiotherapist will create a video record for the patients that will include a detailed description of each exercise. This video recording will be watched at home, and the patients will do video-based exercises by following the instructions in the video.

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.	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