search
Back to results

Effects of Neuromuscular Electrical Stimulation (NMES) in Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimlation (NMES)
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Elderly

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women, minimum age of 50 years;
  • clinically diagnosed with knee OA;
  • no contraindications to execute maximal knee extension tests (e.g., cardiorespiratory complications);
  • no previous musculoskeletal or joint injuries besides knee OA;
  • no hip or knee surgery;
  • no neurological problems.

Sites / Locations

  • Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuromuscular Electrical Stimulation (NMES)

Arm Description

The intervention was performed with subjects seated on a regular chair (hip and knee angles maintained at approximately 908), 3 times/week for a period of 8 weeks. NMES parameters included: rectangular biphasic symmetric current, pulse duration of 400 ms and stimulation frequency of 80 Hz.

Outcomes

Primary Outcome Measures

Peak torque change
Maximal isometric knee extensor torques were obtained on an isokinetic dynamometer (Biodex System 3; Biodex Medical Systems). Participants were positioned on the dynamometer according to the manufacturer's recommendations. After a warm-up and a familiarization session, each subject executed three maximal isometric knee extensor contractions with the knee fixed at a flexion angle of 60o. Each contraction lasted for 5 s and a 2-min interval was observed between consecutive contractions.
Electromyographic activation change
An eight channel EMG system (AMT-8, Bortec Biomedical Ltd., Canada) connected to a Windaq data acquisition system (Dataq Instruments Inc., USA) was used during the maximal isometric and concentric knee extensor contractions. EMG signals were obtained following the recommendations by Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles with respect to skin preparation and electrode positioning. Passive bipolar electrodes (Meditrace - 100; Ag/AgCl; inter-electrode distance = 2.2 cm) were placed on the skin covering the rectus femoris, vastus lateralis and vastus medialis muscles. A reference electrode was placed on the medial surface of the tibia. EMG signals were digitized with a sampling frequency of 2000 Hz per channel with a 16 bits analogue-to-digital board DI-720 (Dataq Instruments Inc., USA) and stored for further analysis.
Muscle architecture change
An ultrassound system (SSD 4000, 51 Hz, ALOKA Inc., Japan) with a linear array probe (60 mm, 7.5 MHz), was used to determine the thickness, fascicle length, and pennation angle of the vastus lateralis muscle. Ultrassound images were obtained at rest with the subject sitting on the chair of an isokinetic dynamometer (Biodex System 3; Biodex Medical Systems, Shirley, NY) with the hip and knee flexed at 85o and 90o, respectively. All images were captured in the sagittal plane of vastus lateralis (at midway between the lateral condyle of the femur and the greater trochanter). The ultrasound probe was positioned in the approximate direction of the vastus lateralis muscle fibers (long axis with respect to the limb).

Secondary Outcome Measures

Full Information

First Posted
February 7, 2014
Last Updated
February 10, 2014
Sponsor
Federal University of Rio Grande do Sul
search

1. Study Identification

Unique Protocol Identification Number
NCT02061410
Brief Title
Effects of Neuromuscular Electrical Stimulation (NMES) in Patients With Knee Osteoarthritis
Official Title
Diagnosis and Treatment of Muscle Inhibition of the Extensor Muscles of the Knee in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the effects of neuromuscular electrical stimulation (NMES) on neuromuscular and functional parameters in elderly with knee osteoarthritis. The hypothesis is that NAMES is able to strengthen the quadriceps muscle and to improve healthy status of elderly with knee osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular Electrical Stimulation (NMES)
Arm Type
Experimental
Arm Description
The intervention was performed with subjects seated on a regular chair (hip and knee angles maintained at approximately 908), 3 times/week for a period of 8 weeks. NMES parameters included: rectangular biphasic symmetric current, pulse duration of 400 ms and stimulation frequency of 80 Hz.
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimlation (NMES)
Intervention Description
The intervention was performed with subjects seated on a regular chair (hip and knee angles maintained at approximately 908), 3 times/week for a period of 8 weeks. NMES parameters included: rectangular biphasic symmetric current, pulse duration of 400 ms and stimulation frequency of 80 Hz.
Primary Outcome Measure Information:
Title
Peak torque change
Description
Maximal isometric knee extensor torques were obtained on an isokinetic dynamometer (Biodex System 3; Biodex Medical Systems). Participants were positioned on the dynamometer according to the manufacturer's recommendations. After a warm-up and a familiarization session, each subject executed three maximal isometric knee extensor contractions with the knee fixed at a flexion angle of 60o. Each contraction lasted for 5 s and a 2-min interval was observed between consecutive contractions.
Time Frame
Baseline and 9th intervention week
Title
Electromyographic activation change
Description
An eight channel EMG system (AMT-8, Bortec Biomedical Ltd., Canada) connected to a Windaq data acquisition system (Dataq Instruments Inc., USA) was used during the maximal isometric and concentric knee extensor contractions. EMG signals were obtained following the recommendations by Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles with respect to skin preparation and electrode positioning. Passive bipolar electrodes (Meditrace - 100; Ag/AgCl; inter-electrode distance = 2.2 cm) were placed on the skin covering the rectus femoris, vastus lateralis and vastus medialis muscles. A reference electrode was placed on the medial surface of the tibia. EMG signals were digitized with a sampling frequency of 2000 Hz per channel with a 16 bits analogue-to-digital board DI-720 (Dataq Instruments Inc., USA) and stored for further analysis.
Time Frame
Baseline and 9th intervention week
Title
Muscle architecture change
Description
An ultrassound system (SSD 4000, 51 Hz, ALOKA Inc., Japan) with a linear array probe (60 mm, 7.5 MHz), was used to determine the thickness, fascicle length, and pennation angle of the vastus lateralis muscle. Ultrassound images were obtained at rest with the subject sitting on the chair of an isokinetic dynamometer (Biodex System 3; Biodex Medical Systems, Shirley, NY) with the hip and knee flexed at 85o and 90o, respectively. All images were captured in the sagittal plane of vastus lateralis (at midway between the lateral condyle of the femur and the greater trochanter). The ultrasound probe was positioned in the approximate direction of the vastus lateralis muscle fibers (long axis with respect to the limb).
Time Frame
Baseline and 9th intervention week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women, minimum age of 50 years; clinically diagnosed with knee OA; no contraindications to execute maximal knee extension tests (e.g., cardiorespiratory complications); no previous musculoskeletal or joint injuries besides knee OA; no hip or knee surgery; no neurological problems.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco A Vaz, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
RS
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Effects of Neuromuscular Electrical Stimulation (NMES) in Patients With Knee Osteoarthritis

We'll reach out to this number within 24 hrs