Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries

NCT ID: NCT00732017

Last Updated: 2008-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Ankle Sprain

Keywords

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Sprain Electric stimulation Physical trauma Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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HVPC-

This group received standard physical therapy treatment and HVPC with negative polarity.

Group Type EXPERIMENTAL

high voltage pulse stimulation with negative polarity

Intervention Type 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.

CG

The control group received only standard physical therapy treatment.

Group Type ACTIVE_COMPARATOR

standard physical therapy treatment

Intervention Type 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.

HVPC+

This group received standard physical therapy treatment and HVPC using active electrodes with positive polarity.

Group Type EXPERIMENTAL

Standard physical therapy and HVPC with positive polarity

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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electrical stimulation electrical current electrical stimulation electrical current standard care

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Industrial de Santander

OTHER

Sponsor Role lead

Responsible Party

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Universidade Federal de Sao Carlos

Principal Investigators

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Maria Cristina Sandoval Ortiz, M.Sc in P.T.

Role: PRINCIPAL_INVESTIGATOR

Industrial University of Santander

Liliana Carolina Ramirez Ramirez, P.T.

Role: PRINCIPAL_INVESTIGATOR

Industrial University of Santander

Diana Marina Camargo Lemos, M.Sc. Epid.

Role: STUDY_CHAIR

Industrial University of Santander

Tania De Fatima Salvini, Ph.D

Role: STUDY_CHAIR

Universidade Federal de Sao Carlos

Locations

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Industrial University of Santander UIS

Bucaramanga, Santander Department, Colombia

Site Status

Countries

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Colombia

References

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Griffin JW, Newsome LS, Stralka SW, Wright PE. Reduction of chronic posttraumatic hand edema: a comparison of high voltage pulsed current, intermittent pneumatic compression, and placebo treatments. Phys Ther. 1990 May;70(5):279-86. doi: 10.1093/ptj/70.5.279.

Reference Type BACKGROUND
PMID: 2185495 (View on PubMed)

Cosgrove KA, Alon G, Bell SF, Fischer SR, Fowler NR, Jones TL, Myaing JC, Crouse TM, Seaman LJ. The electrical effect of two commonly used clinical stimulators on traumatic edema in rats. Phys Ther. 1992 Mar;72(3):227-33. doi: 10.1093/ptj/72.3.227.

Reference Type BACKGROUND
PMID: 1584856 (View on PubMed)

Taylor K, Mendel FC, Fish DR, Hard R, Burton HW. Effect of high-voltage pulsed current and alternating current on macromolecular leakage in hamster cheek pouch microcirculation. Phys Ther. 1997 Dec;77(12):1729-40. doi: 10.1093/ptj/77.12.1729.

Reference Type BACKGROUND
PMID: 9413451 (View on PubMed)

Taylor K, Fish DR, Mendel FC, Burton HW. Effect of a single 30-minute treatment of high voltage pulsed current on edema formation in frog hind limbs. Phys Ther. 1992 Jan;72(1):63-8. doi: 10.1093/ptj/72.1.63.

Reference Type BACKGROUND
PMID: 1728050 (View on PubMed)

Fish DR, Mendel FC, Schultz AM, Gottstein-Yerke LM. Effect of anodal high voltage pulsed current on edema formation in frog hind limbs. Phys Ther. 1991 Oct;71(10):724-30; discussion 730-3. doi: 10.1093/ptj/71.10.724.

Reference Type BACKGROUND
PMID: 1946611 (View on PubMed)

Mendel FC, Wylegala JA, Fish DR. Influence of high voltage pulsed current on edema formation following impact injury in rats. Phys Ther. 1992 Sep;72(9):668-73. doi: 10.1093/ptj/72.9.668.

Reference Type BACKGROUND
PMID: 1508974 (View on PubMed)

Bettany JA, Fish DR, Mendel FC. Influence of high voltage pulsed direct current on edema formation following impact injury. Phys Ther. 1990 Apr;70(4):219-24. doi: 10.1093/ptj/70.4.219.

Reference Type BACKGROUND
PMID: 2315384 (View on PubMed)

Bettany JA, Fish DR, Mendel FC. High-voltage pulsed direct current: effect on edema formation after hyperflexion injury. Arch Phys Med Rehabil. 1990 Aug;71(9):677-81.

Reference Type BACKGROUND
PMID: 2375674 (View on PubMed)

Karnes JL, Mendel FC, Fish DR. Effects of low voltage pulsed current on edema formation in frog hind limbs following impact injury. Phys Ther. 1992 Apr;72(4):273-8. doi: 10.1093/ptj/72.4.273.

Reference Type BACKGROUND
PMID: 1584859 (View on PubMed)

Thornton RM, Mendel FC, Fish DR. Effects of electrical stimulation on edema formation in different strains of rats. Phys Ther. 1998 Apr;78(4):386-94. doi: 10.1093/ptj/78.4.386.

Reference Type BACKGROUND
PMID: 9555921 (View on PubMed)

Dolan MG, Mychaskiw AM, Mendel FC. Cool-Water Immersion and High-Voltage Electric Stimulation Curb Edema Formation in Rats. J Athl Train. 2003 Sep;38(3):225-230.

Reference Type BACKGROUND
PMID: 14608432 (View on PubMed)

Karnes JL, Mendel FC, Fish DR, Burton HW. High-voltage pulsed current: its influence on diameters of histamine-dilated arterioles in hamster cheek pouches. Arch Phys Med Rehabil. 1995 Apr;76(4):381-6. doi: 10.1016/s0003-9993(95)80665-2.

Reference Type BACKGROUND
PMID: 7717840 (View on PubMed)

Dolan MG, Mychaskiw AM, Mattacola CG, Mendel FC. Effects of Cool-Water Immersion and High-Voltage Electric Stimulation for 3 Continuous Hours on Acute Edema in Rats. J Athl Train. 2003 Dec;38(4):325-329.

Reference Type BACKGROUND
PMID: 14737215 (View on PubMed)

Dolan MG, Graves P, Nakazawa C, Delano T, Hutson A, Mendel FC. Effects of Ibuprofen and High-Voltage Electric Stimulation on Acute Edema Formation After Blunt Trauma to Limbs of Rats. J Athl Train. 2005 Jun;40(2):111-115.

Reference Type BACKGROUND
PMID: 15970957 (View on PubMed)

Mohr TM, Akers TK, Landry RG. Effect of high voltage stimulation on edema reduction in the rat hind limb. Phys Ther. 1987 Nov;67(11):1703-7. doi: 10.1093/ptj/67.11.1703.

Reference Type BACKGROUND
PMID: 3499622 (View on PubMed)

Cook HA, Morales M, La Rosa EM, Dean J, Donnelly MK, McHugh P, Otradovec A, Wright KS, Kula T, Tepper SH. Effects of electrical stimulation on lymphatic flow and limb volume in the rat. Phys Ther. 1994 Nov;74(11):1040-6. doi: 10.1093/ptj/74.11.1040.

Reference Type BACKGROUND
PMID: 7972365 (View on PubMed)

Mendel FC, Fish DR. New Perspectives in Edema Control via Electrical Stimulation. J Athl Train. 1993 Spring;28(1):63-74.

Reference Type BACKGROUND
PMID: 16558209 (View on PubMed)

Reed BV. Effect of high voltage pulsed electrical stimulation on microvascular permeability to plasma proteins. A possible mechanism in minimizing edema. Phys Ther. 1988 Apr;68(4):491-5. doi: 10.1093/ptj/68.4.491.

Reference Type BACKGROUND
PMID: 2451258 (View on PubMed)

Sandoval MC, Ramirez C, Camargo DM, Salvini TF. Effect of high-voltage pulsed current plus conventional treatment on acute ankle sprain. Rev Bras Fisioter. 2010 May-Jun;14(3):193-9. doi: 10.1590/s1413-35552010000300012.

Reference Type DERIVED
PMID: 20730362 (View on PubMed)

Related Links

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http://www.uis.edu.co

Universidad Industrial de Santander - Home page

http://www.ufscar.br

Universidade Federal de Sao Carlos - Home page

Other Identifiers

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5612

Identifier Type: -

Identifier Source: org_study_id