Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries

August 6, 2008 updated by: Universidad Industrial de Santander

Effects Of High Voltage Pulsed Current On Ankle 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Santander
      • Bucaramanga, Santander, Colombia
        • Industrial University of Santander UIS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HVPC-
This group received standard physical therapy treatment and HVPC with negative polarity.
Device: high voltage pulse stimulation with negative polarity
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
Active Comparator: CG
The control group received only standard physical therapy treatment.
Other: standard physical therapy treatment
  • 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
Experimental: HVPC+
This group received standard physical therapy treatment and HVPC using active electrodes with positive polarity.
Device: Standard physical therapy and HVPC with positive polarity
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
The ROM was measured before and at the end of the treatment.
Edema was assessed with measures of ankle girth and volume.
Time Frame: The edema was measured before and at the end of the treatment.
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.
Time Frame: The variables of gait were measured before and at the end of the treatment
The variables of gait were measured before and at the end of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Industrial de Santander

Investigators

  • Principal Investigator: Maria Cristina Sandoval Ortiz, M.Sc in P.T., Industrial University of Santander
  • Principal Investigator: Liliana Carolina Ramirez Ramirez, P.T., Industrial University of Santander
  • Study Chair: Diana Marina Camargo Lemos, M.Sc. Epid., Industrial University of Santander
  • Study Chair: Tania De Fatima Salvini, Ph.D, Universidade Federal de Sao Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

August 11, 2008

Last Update Submitted That Met QC Criteria

August 6, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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