Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries
Primary Purpose
Ankle Sprain
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Standard physical therapy and HVPC with positive polarity
high voltage pulse stimulation with negative polarity
standard physical therapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Sprain focused on measuring Sprain, Electric stimulation, Physical trauma, Inflammation
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.
Sites / Locations
- Industrial University of Santander UIS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
HVPC-
CG
HVPC+
Arm Description
This group received standard physical therapy treatment and HVPC with negative polarity.
The control group received only standard physical therapy treatment.
This group received standard physical therapy treatment and HVPC using active electrodes with positive polarity.
Outcomes
Primary Outcome Measures
Pain with the visual analogue scale.
Secondary Outcome Measures
Range of movement (ROM) of plantar and dorsal flexion, inversion and eversion were measured with a goniometer.
Edema was assessed with measures of ankle girth and volume.
Some descriptive variables of gait such as step and stride length, and the gait speed.
Full Information
NCT ID
NCT00732017
First Posted
August 6, 2008
Last Updated
August 6, 2008
Sponsor
Universidad Industrial de Santander
1. Study Identification
Unique Protocol Identification Number
NCT00732017
Brief Title
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
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidad Industrial de Santander
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
Sprain, Electric stimulation, Physical trauma, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HVPC-
Arm Type
Experimental
Arm Description
This group received standard physical therapy treatment and HVPC with negative polarity.
Arm Title
CG
Arm Type
Active Comparator
Arm Description
The control group received only standard physical therapy treatment.
Arm Title
HVPC+
Arm Type
Experimental
Arm Description
This group received standard physical therapy treatment and HVPC using active electrodes with positive polarity.
Intervention Type
Device
Intervention Name(s)
Standard physical therapy and HVPC with positive polarity
Other Intervention Name(s)
electrical stimulation, electrical current
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
high voltage pulse stimulation with negative polarity
Other Intervention Name(s)
electrical stimulation, electrical current
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standard physical therapy treatment
Other Intervention Name(s)
standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain with the visual analogue scale.
Time Frame
The pain was measured before and at the end of the treatment.
Secondary Outcome Measure Information:
Title
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.
Title
Edema was assessed with measures of ankle girth and volume.
Time Frame
The edema was measured before and at the end of the treatment.
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Cristina Sandoval Ortiz, M.Sc in P.T.
Organizational Affiliation
Industrial University of Santander
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liliana Carolina Ramirez Ramirez, P.T.
Organizational Affiliation
Industrial University of Santander
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diana Marina Camargo Lemos, M.Sc. Epid.
Organizational Affiliation
Industrial University of Santander
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tania De Fatima Salvini, Ph.D
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Study Chair
Facility Information:
Facility Name
Industrial University of Santander UIS
City
Bucaramanga
State/Province
Santander
Country
Colombia
12. IPD Sharing Statement
Citations:
PubMed Identifier
2185495
Citation
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Citation
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Citation
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Citation
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Citation
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derived
Links:
URL
http://www.uis.edu.co
Description
Universidad Industrial de Santander - Home page
URL
http://www.ufscar.br
Description
Universidade Federal de Sao Carlos - Home page
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Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries
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