Skip to main content
OpenTrials
Completed

NCT Number: NCT06447129

Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears

This randomized-controlled trial aims to investigate the effect of NMES as an add-on to an exercise program in patients with degenerative meniscus tears.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Degenerative Disease Knee Pain Swelling Meniscus Tear

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

About this study

To investigate the efficacy of NMES as an add-on to an exercise program, voluntary patients with degenerative meniscus tears, aged between 40 and 65 years, will be randomly divided into two groups: Group 1 (NMES with Exercise) and Group 2 (Exercise). 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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exercise

Other

An 8-week exercise program used in conservative treatment of degenerative meniscus tears will be performed.

The patients will do exercises under the control of the physiotherapist in the clinic.

The patient will perform the exercises with the verbal and visual commands of the physiotherapist.

Neuromuscular electrical stimulation

Other

The Neuromuscular Electrical Stimulation (NMES) will be applied for 20 minutes. The patient will be seated with hips and knees flexed at 90°. Electrodes will be placed on the proximal and distal ends of the vastus medialis obliquus and vastus lateralis muscles. The intensity will be increased as much as the patient can tolerate, and the patient will be asked to relax and not make voluntary muscle contractions.

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 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 outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 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)

    Time frame: 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)

    Time frame: At the end of 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 6, 2024
Registry last updated
Jan 30, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.