Effects of Low Frequency Neuromuscular Electrical Stimulation Applied to the Quadriceps in the Production of Knee Extension Strength and Control of Edema After Anterior Cruciate Ligament Reconstruction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01633047
First received: July 3, 2012
Last updated: July 9, 2012
Last verified: June 2012

July 3, 2012
July 9, 2012
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Complete list of historical versions of study NCT01633047 on ClinicalTrials.gov Archive Site
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Effects of Low Frequency Neuromuscular Electrical Stimulation Applied to the Quadriceps in the Production of Knee Extension Strength and Control of Edema After Anterior Cruciate Ligament Reconstruction
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The anterior cruciate ligament (ACL) is frequently injured, and it is the structure of the athlete´s knee which has the highest prevalence of reconstruction. Given this postoperative ACL reconstruction scenario the investigator find in literature the effectiveness of neuromuscular electrical stimulation (NMES) as an adjuvant treatment for strengthening the quadriceps muscle. The intensity of NMES and the training duration are important factors for a successful treatment.

The purpose of this study is to compare two rehabilitation protocols in patients during the post operative of the ACL reconstruction over the strength of knee extension and control of edema.

It will be a randomized controlled study with the CONSORT bases with 40 participants that will be divided into two groups: Control group that will be submitted only to physical therapy exercises, and the Intervention group that will be submitted to physical therapy exercises plus electrical stimulation (low frequency device with a current of 47 Hz with symmetrical, biphasic and pyramidal waveforms, with pulse duration of 1.5 s and interval of 1.8 s). The procedure will last six weeks. It will be evaluated the pre intervention quadriceps muscle extension force by means of a manual dynamometer, and the joint swelling through the perimeter. This procedure will be repeated after six weeks of intervention. Results are expressed as hazard ratios (HR) with their respective confidence intervals at 95% and adopting α = 0.05. All analyzes will be performed by SPSS version 17.0

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Interventional
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Athlete´s Knee
  • Other: electrical stimulation
    Intervention group that will be submitted to physical therapy exercises plus electrical stimulation (low frequency device with a current of 47 Hz with symmetrical, biphasic and pyramidal waveforms, with pulse duration of 1.5 s and interval of 1.8 s)
  • Other: physical therapy exercises
    Control group that will be submitted only to physical therapy exercises
  • Experimental: Intervention
    Intervention: Other: electrical stimulation
  • Sham Comparator: Control
    Intervention: Other: physical therapy exercises
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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Inclusion Criteria:

  • Subjects between 18 e 45 years old, submitted in the last 15 days to the ACL reconstruction surgery, being the first knee lesion episode.

Exclusion Criteria:

  • Patients cannot present any constrains regarding the physical activity practice according to the Sports Medicine American College.
  • cartilage degeneration with a degree higher than 2 according to the cartilage Repair International Society
  • Presence of other ligamentary lesions associated to the ACL reconstruction.
  • Utilization of complementary therapies parallel to the treatment.
Both
18 Years and older
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Contact: Tiago Alves Bozzo 551199098767 tiagobozzo@hotmail.com
Brazil
 
NCT01633047
CAAE 01430812.1.0000.5505
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Federal University of São Paulo
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Federal University of São Paulo
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP