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

NCT06447129 | Completed

• 1 other identifier: 216
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Degenerative Disease; Meniscus Tear; Knee Pain Swelling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  At the end of 8-week intervention

• Visual Analogue Scale (VAS)

  Baseline

• Visual Analogue Scale (VAS)

  At the end of 8-week intervention

• Active Range of Motion

  Baseline

• Active Range of Motion

  At the end of 8-week intervention

Study Arms (2)

NMES with Exercise

EXPERIMENTAL

Each subject in Group 2 will receive a treatment protocol consisting of stretching exercises, strengthening exercises, functional exercises for the knee and hip, and NMES application for the quadriceps femoris muscle.

Other: Exercise; Other: Neuromuscular electrical stimulation

Exercise

ACTIVE COMPARATOR

Each subject in Group 2 will receive a treatment protocol consisting of stretching exercises, strengthening exercises, functional exercises for the knee and hip.

Other: Exercise

Interventions

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.

Exercise; NMES with Exercise

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.

NMES with Exercise

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 6, 2024
• Study Start: June 10, 2024
• Primary Completion: November 30, 2024
• Study Completion: January 28, 2025
• Last Updated: January 30, 2025

Record last verified: 2024-06

Locations

TU (1)