Skip to main content
OpenTrials
Completed

NCT Number: NCT00732017

Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ankle Sprain Ankle Injuries Inflammation Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Industrial University of Santander UIS

Bucaramanga, Santander Department, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard physical therapy and HVPC with positive polarity

Device

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.

Other names: electrical stimulation, electrical current

high voltage pulse stimulation with negative polarity

Device

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.

Other names: electrical stimulation, electrical current

standard physical therapy treatment

Other
  • 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.

Other names: standard care

Primary outcomes

  1. Pain with the visual analogue scale.

    Time frame: The pain was measured before and at the end of the treatment.

Secondary outcomes

  1. Range of movement (ROM) of plantar and dorsal flexion, inversion and eversion were measured with a goniometer.

    Time frame: The ROM was measured before and at the end of the treatment.

  2. Edema was assessed with measures of ankle girth and volume.

    Time frame: The edema was measured before and at the end of the treatment.

  3. Some descriptive variables of gait such as step and stride length, and the gait speed.

    Time frame: The variables of gait were measured before and at the end of the treatment

Sponsors and collaborators

Lead sponsor

Universidad Industrial de Santander

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 11, 2008
Registry last updated
Aug 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.