Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries

NCT00732017 | Completed DMC

• 1 other identifier: 5612
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprain

Keywords

Sprain; Electric stimulation; Physical trauma; Inflammation

Outcome Measures

Primary Outcomes (1)

• Pain with the visual analogue scale.

  The pain was measured before and at the end of the treatment.

Secondary Outcomes (3)

• 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.

• Edema was assessed with measures of ankle girth and volume.

  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.

  The variables of gait were measured before and at the end of the treatment

Study Arms (3)

HVPC-

EXPERIMENTAL

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

Device: high voltage pulse stimulation with negative polarity

CG

ACTIVE COMPARATOR

The control group received only standard physical therapy treatment.

Other: standard physical therapy treatment

HVPC+

EXPERIMENTAL

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

Device: Standard physical therapy and HVPC with positive polarity

Interventions

Standard physical therapy and HVPC with positive polarity 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.

Also known as: electrical stimulation, electrical current

HVPC+

high voltage pulse stimulation with negative polarity 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.

Also known as: electrical stimulation, electrical current

HVPC-

standard physical therapy treatment 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.

Also known as: standard care

CG

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Industrial de Santander: lead

Study Sites (1)

Industrial University of Santander UIS

Bucaramanga, Santander Department, Colombia

Location

Related Publications (19)

• 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.

  PMID: 2185495 BACKGROUND

• 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.

  PMID: 1584856 BACKGROUND

• 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.

  PMID: 9413451 BACKGROUND

• 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.

  PMID: 1728050 BACKGROUND

• 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.

  PMID: 1946611 BACKGROUND

• 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.

  PMID: 1508974 BACKGROUND

• 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.

  PMID: 2315384 BACKGROUND

• 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.

  PMID: 2375674 BACKGROUND

• 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.

  PMID: 1584859 BACKGROUND

• 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.

  PMID: 9555921 BACKGROUND

• 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.

  PMID: 14608432 BACKGROUND

• 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.

  PMID: 7717840 BACKGROUND

• 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.

  PMID: 14737215 BACKGROUND

• 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.

  PMID: 15970957 BACKGROUND

• 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.

  PMID: 3499622 BACKGROUND

• 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.

  PMID: 7972365 BACKGROUND

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

  PMID: 16558209 BACKGROUND

• 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.

  PMID: 2451258 BACKGROUND

• 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.

  PMID: 20730362 DERIVED

Related Links

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

MeSH Terms

Conditions

Ankle Injuries; Sprains and Strains; Wounds and Injuries; Inflammation

Interventions

Electric Stimulation; Standard of Care

Condition Hierarchy (Ancestors)

Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Diana Marina Camargo Lemos, M.Sc. Epid.

  Industrial University of Santander

  STUDY CHAIR

• Tania De Fatima Salvini, Ph.D

  Universidade Federal de Sao Carlos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 11, 2008
• Study Start: February 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 11, 2008

Record last verified: 2008-08

Locations

CO (1)