Clinical trial NCT00732017: Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries
Official title: Effects Of High Voltage Pulsed Current On Ankle Post-Traumatic Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprain
Keywords: Sprain
Electric stimulation
Physical trauma
Inflammation
Lead sponsor: Universidad Industrial de Santander
Sponsor class: OTHER
First posted: 2008-08-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain with the visual analogue scale.
timeFrame: The pain was measured before and at the end of the treatment.
Secondary outcomes:
measure: Range of movement (ROM) of plantar and dorsal flexion, inversion and eversion were measured with a goniometer.
timeFrame: The ROM was measured before and at the end of the treatment.
measure: Edema was assessed with measures of ankle girth and volume.
timeFrame: The edema was measured before and at the end of the treatment.
measure: Some descriptive variables of gait such as step and stride length, and the gait speed.
timeFrame: The variables of gait were measured before and at the end of the treatment
Other outcomes:
Locations:
city: Bucaramanga
country: Colombia
facility: Industrial University of Santander UIS
state: Santander
Study officials:
affiliation: Industrial University of Santander
name: Maria Cristina Sandoval Ortiz, M.Sc in P.T.
role: PRINCIPAL_INVESTIGATOR
affiliation: Industrial University of Santander
name: Liliana Carolina Ramirez Ramirez, P.T.
role: PRINCIPAL_INVESTIGATOR
affiliation: Industrial University of Santander
name: Diana Marina Camargo Lemos, M.Sc. Epid.
role: STUDY_CHAIR
affiliation: Universidade Federal de Sao Carlos
name: Tania De Fatima Salvini, Ph.D
role: STUDY_CHAIR
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