Investigation of the Efficacy of Video-Based Exercise Program in Degenerative Meniscus Tear

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05266365
Collaborator
(none)
50
1
2
8.5
5.9

Study Details

Study Description

Brief Summary

This randomized-controlled trial aims to investigate the efficacy of video-based exercise program in patients with degenerative meniscus tear.

Condition or Disease Intervention/Treatment Phase
  • Other: Video-based exercise program
  • Other: Standard exercise program
N/A

Detailed Description

To investigate the efficacy of video-based exercise program, voluntary patients with degenerative meniscus tear, aged between 40-65 years will be randomly divided into two groups: Video-based exercise (VBE) group and standard exercise (SE) 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 on activity, at rest and at night will be assessed with 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 Short Form-12 (SF-12).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigation of the Efficacy of Video-Based Exercise Program in Degenerative Meniscus Tear
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Video-based exercise group

Each subject in the video-based exercise group will receive a treatment protocol consisting of stretching exercises, strengthening exercises and functional exercises for knee and hip.

Other: Video-based exercise program
A 8-week exercise program used in conservative treatment of degenerative meniscus tear will be performed. A video record will be prepared by the physiotherapist to the patients where each exercise will be described in detail. This video record will be watched in the clinic and the patients will do video-baed exercises by following th instructions in the video. The patient will be performed the exercises without any the verbal and visual commands of the physiotherapist, who is in the clinic.

Active Comparator: Standard exercise group

Each subject in the standard exercise group will receive a treatment protocol consisting of stretching exercises, strengthening exercises and functional exercises for knee and hip.

Other: Standard exercise program
A 8-week exercise program used in conservative treatment of degenerative meniscus tear will be performed. The patients will do exercises under control of the physiotherapist in the clinic. The patient will be performed the exercises with the verbal and visual commands of the physiotherapist.

Outcome Measures

Primary Outcome Measures

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [Baseline]

    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.

Secondary Outcome Measures

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [At the end of 8-week intervention]

    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.

  2. Visual Analogue Scale (VAS) [Baseline]

    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.

  3. Visual Analogue Scale (VAS) [After 8-week intervention]

    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.

  4. Active Range of Motion [Baseline]

    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.

  5. Active Range of Motion [At the end of 8-week intervention]

    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.

  6. Muscle Strength [Baseline]

    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.

  7. Muscle Strength [At the end of the 8-week intervention]

    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.

  8. Lysholm Score [Baseline]

    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.

  9. Lysholm Score [At the end of the 8-week intervention]

    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.

  10. Short Form-12 (SF-12) [Baseline]

    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.

  11. Short Form-12 (SF-12) [At the end of the 8-week intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University-Cerrahpasa Istanbul Bakırkoy Turkey 34147

Sponsors and Collaborators

  • Istanbul University-Cerrahpasa

Investigators

  • Principal Investigator: Tansu Birinci, PhD, PT, Istanbul University-Cerrahpasa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tansu Birinci, Principal Investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier:
NCT05266365
Other Study ID Numbers:
  • 107
First Posted:
Mar 4, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 10, 2022