- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02061410
Effects of Neuromuscular Electrical Stimulation (NMES) in Patients With Knee Osteoarthritis
February 10, 2014 updated by: Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
Diagnosis and Treatment of Muscle Inhibition of the Extensor Muscles of the Knee in Elderly
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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RS
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Porto Alegre, RS, Brazil
- Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neuromuscular Electrical Stimulation (NMES)
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak torque change
Time Frame: Baseline and 9th intervention week
|
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.
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Baseline and 9th intervention week
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Electromyographic activation change
Time Frame: Baseline and 9th intervention week
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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.
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Baseline and 9th intervention week
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Muscle architecture change
Time Frame: Baseline and 9th intervention week
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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).
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Baseline and 9th intervention week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
February 7, 2014
First Submitted That Met QC Criteria
February 10, 2014
First Posted (Estimate)
February 12, 2014
Study Record Updates
Last Update Posted (Estimate)
February 12, 2014
Last Update Submitted That Met QC Criteria
February 10, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFRGS-2007791
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
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Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
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Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
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The Hong Kong Polytechnic UniversityCompleted
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