Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries

Study Overview
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Brief Summary
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The investigators hypothesis is that HVPC with negative polarity diminishes local post-traumatic edema in ankle sprains. Therefore, the objective of this study was to analyze the effect of HVPC on edema secondary to ankle sprains in humans.

Detailed Description
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Most studies have investigated the effects of HVPC on edema in animals and only one in humans was identified. The studies had showed that HVPC had some advantages for controlling edema in animals but there are not yet conclusive results on the effect of this intervention in humans.For this reason, we proposed a randomized controlled double-blinded clinical trial with three groups of intervention. In our study compared the effects of standard physical therapy treatment with the HVPC with negative and positive polarity.

Official Title
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Effects Of High Voltage Pulsed Current On Ankle Post-Traumatic Injuries

Conditions
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Ankle Sprain

Intervention / Treatment
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* Device: Standard physical therapy and HVPC with positive polarity
* Device: high voltage pulse stimulation with negative polarity
* Other: standard physical therapy treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ankle post traumatic edema secondary to a sprain Sprain with evolution between 2 and 96 hours Sprain positive to anterior drawer test or lateral inclination mobilizations. Exclusion Criteria: Subjects with grade III sprains that required surgical management Edema secondary to systemic illness Muscular dystrophy or atrophy Injuries, open or infected zones People taking anti-inflammatory medication or using empirical treatment as tractions, strong massages or manual.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HVPC-<br>This group received standard physical therapy treatment and HVPC with negative polarity. | Device: high voltage pulse stimulation with negative polarity<br>* A high voltage stimulator with negative polarity was used with a direct pulsed monophasic current, double peak, 5 and 8micros duration and separated by a pulsate interval of 75micros and monopolar application with a dispersive electrode in the lumbar region and two transarticular active electrodes. The intensity of the current was under motor level, that is, just before a visible motor response could be observed. The frequency used was 120pps, in a continuous mode and was applied once a day with thirty-minute duration.<br>* Other names: electrical current;|
| Active Comparator: CG<br>The control group received only standard physical therapy treatment. | Other: standard physical therapy treatment<br>* Initial phase: Application of crushed ice on the ankle for 20 minutes. The subject performed isometric and active exercises of the ankle in all freedom degrees, with no weight bearing. Intermediate phase: Application of cryotherapy continued and once mobility was completed and painless, progressive use of weight and reeducation of the walking pattern were initiated. Then, exercises with manual resistance of muscles of ankle and balance in stable surfaces were done. Advanced phase: Balance exercises on unstable surfaces as well as strengthening ankle muscles with proprioceptive neuromuscular facilitation techniques and elastic band were performed. At the end, the patient did activities like trotting in S or Z and jumping in all directions.<br>* Other names: standard care;|
| Experimental: HVPC+<br>This group received standard physical therapy treatment and HVPC using active electrodes with positive polarity. | Device: Standard physical therapy and HVPC with positive polarity<br>* A high voltage stimulator with positive polarity was used with a direct pulsed monophasic current, double peak, 5 and 8micros duration and separated by a pulsate interval of 75micros and monopolar application with a dispersive electrode in the lumbar region and two transarticular active electrodes. The intensity of the current was under motor level, that is, just before a visible motor response could be observed. The frequency used was 120pps, in a continuous mode and was applied once a day with thirty-minute duration.<br>* Other names: electrical current;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain with the visual analogue scale. |  | The pain was measured before and at the end of the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of movement (ROM) of plantar and dorsal flexion, inversion and eversion were measured with a goniometer. |  | The ROM was measured before and at the end of the treatment. | 
| Edema was assessed with measures of ankle girth and volume. |  | The edema was measured before and at the end of the treatment. | 
| Some descriptive variables of gait such as step and stride length, and the gait speed. |  | The variables of gait were measured before and at the end of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sprain, Electric stimulation, Physical trauma, Inflammation