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Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries

This study has been completed.
Sponsor:
Information provided by:
Universidad Industrial de Santander
ClinicalTrials.gov Identifier:
NCT00732017
First received: August 6, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Ankle Sprain
 Device: Standard physical therapy and HVPC with positive polarity
Device: high voltage pulse stimulation with negative polarity
Other: standard physical therapy treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects Of High Voltage Pulsed Current On Ankle Post-Traumatic Injuries

Resource links provided by NLM:

MedlinePlus related topics: Edema Injuries Wounds
U.S. FDA Resources

Further study details as provided by Universidad Industrial de Santander:

Primary Outcome Measures:
  • Pain with the visual analogue scale. [ Time Frame: The pain was measured before and at the end of the treatment. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • Edema was assessed with measures of ankle girth and volume. [ Time Frame: The edema was measured before and at the end of the treatment. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: February 2004
Study Completion Date: December 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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

Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732017

Locations
Colombia
Industrial University of Santander UIS
Bucaramanga, Santander, Colombia
Sponsors and Collaborators
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
  More Information

Additional Information:
Universidad Industrial de Santander - Home page  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tania de Fátima Salvini, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT00732017     History of Changes
Other Study ID Numbers: 5612
Study First Received: August 6, 2008
Last Updated: August 6, 2008
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad Industrial de Santander:
Sprain
Electric stimulation
Physical trauma
Inflammation

Additional relevant MeSH terms:
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013