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
Recruitment status was Recruiting
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Purpose
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
| Condition | Intervention |
|---|---|
|
Athlete´s Knee |
Other: electrical stimulation Other: physical therapy exercises |
| Study Type: | Interventional |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intervention |
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)
|
| Sham Comparator: Control |
Other: physical therapy exercises
Control group that will be submitted only to physical therapy exercises
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01633047
| Contact: Tiago Alves Bozzo | 551199098767 | tiagobozzo@hotmail.com |
| Brazil | |
| Universidade Federal de São Paulo | Recruiting |
| São Paulo, SP, Brazil, 04039-001 | |
| Contact: Tiago Alves Bozzo 551199098767 tiagobozzo@hotmail.com | |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01633047 History of Changes |
| Other Study ID Numbers: | CAAE 01430812.1.0000.5505 |
| Study First Received: | July 3, 2012 |
| Last Updated: | July 9, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research Brazil: Ministry of Health Brazil: Ethics Committee |
Keywords provided by Federal University of São Paulo:
|
Anterior Cruciate Ligament Electric Stimulation Therapy |
ClinicalTrials.gov processed this record on March 01, 2015