Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries

Ankle Sprain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732017
• Other study ID #: 5612
• Status: Completed
• Phase: N/A
• First received: August 6, 2008
• Last updated: August 6, 2008
• Start date: February 2004
• Est. completion date: December 2006

Study information

• Verified date: August 2008
• Source: Universidad Industrial de Santander
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 26 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Sprain
• Wounds and Injuries

Intervention

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.
• 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:
• 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.

Locations

Country	Name	City	State
Colombia	Industrial University of Santander UIS	Bucaramanga	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Industrial de Santander

Country where clinical trial is conducted

Colombia, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain with the visual analogue scale.		The pain was measured before and at the end of the treatment.	Yes
Secondary	Range of movement (ROM) of plantar and dorsal flexion, inversion and eversion were measured with a goniometer.		The ROM was measured before and at the end of the treatment.	Yes
Secondary	Edema was assessed with measures of ankle girth and volume.		The edema was measured before and at the end of the treatment.	Yes
Secondary	Some descriptive variables of gait such as step and stride length, and the gait speed.		The variables of gait were measured before and at the end of the treatment	Yes

External Links

•   Universidad Industrial de Santander - Home page
•   Universidade Federal de Sao Carlos - Home page