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

NCT ID: NCT06447129

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2025-01-28

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Degenerative Disease Meniscus Tear Knee Pain Swelling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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NMES with Exercise

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type 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

Intervention Type 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.

Exercise

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

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type 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.

Interventions

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Exercise

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.

Intervention Type OTHER

Neuromuscular electrical stimulation

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Tansu Birinci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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216

Identifier Type: -

Identifier Source: org_study_id

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