Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries

Not Applicable

Completed

• Conditions: Ankle Sprain
• Interventions: Device: high voltage pulse stimulation with negative polarity; Other: standard physical therapy treatment; Device: Standard physical therapy and HVPC with positive polarity

• Registration Number: NCT00732017
• Lead Sponsor: Universidad Industrial de Santander

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.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2006-09
• Study Completion: 2006-12
• Status Verified: 2008-08
• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-06
• Last Update Submitted: 2008-08-06
• Study First Posted: 2008-08-11
• Last Update Posted: 2008-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HVPC-	high voltage pulse stimulation with negative polarity	This group received standard physical therapy treatment and HVPC with negative polarity.
CG	standard physical therapy treatment	The control group received only standard physical therapy treatment.
HVPC+	Standard physical therapy and HVPC with positive polarity	This group received standard physical therapy treatment and HVPC using active electrodes with positive polarity.

Primary Outcome Measures

Name	Time	Method
Pain with the visual analogue scale.	The pain was measured before and at the end of the treatment.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Industrial University of Santander UIS; 🇨🇴 Bucaramanga, Santander, Colombia