Ankle SprainNCT00732017
Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries
A study testing Standard physical therapy and HVPC with positive polarity, high voltage pulse stimulation with negative polarity and standard physical therapy treatment in people with Ankle Sprain, run by Universidad Industrial de Santander at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Standard physical therapy and HVPC with positive polarity, high voltage pulse stimulation with negative polarity and standard physical therapy treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteColombia
- Study dates
- Feb 2004to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Industrial University of Santander UIS
Bucaramanga, Santander Department
About this study
Official title: Effects Of High Voltage Pulsed Current On Ankle Post-Traumatic Injuries
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.
Read the 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.
- Conditions
- Ankle Sprain
- Being tested
- Standard physical therapy and HVPC with positive polarity, high voltage pulse stimulation with negative polarity, standard physical therapy treatment
- Keywords
- Sprain, Electric stimulation, Physical trauma, Inflammation
- Medical subject headings
- Ankle Injuries, Sprains and Strains, Wounds and Injuries, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard physical therapy and HVPC with positive polarityDevice
Also called electrical stimulation, electrical current
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 polarityDevice
Also called electrical stimulation, electrical current
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.
standard physical therapy treatmentOther
Also called standard care
- 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.
| Study group | Role | What they receive |
|---|---|---|
| HVPC- | Experimental | This group received standard physical therapy treatment and HVPC with negative polarity. Receives: Device: high voltage pulse stimulation with negative polarity |
| CG | Active comparator | The control group received only standard physical therapy treatment. Receives: Other: standard physical therapy treatment |
| HVPC+ | Experimental | This group received standard physical therapy treatment and HVPC using active electrodes with positive polarity. Receives: Device: Standard physical therapy and HVPC with positive polarity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain with the visual analogue scale.
Measured: 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.
Measured: The ROM was measured before and at the end of the treatment.
Edema was assessed with measures of ankle girth and volume.
Measured: 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.
Measured: The variables of gait were measured before and at the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startFeb 2004
- Primary completionSep 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Industrial de Santander
- Sponsor type
- University, hospital or other
- Investigators
- Maria Cristina Sandoval Ortiz, M.Sc in P.T., Principal investigator, Industrial University of SantanderLiliana Carolina Ramirez Ramirez, P.T., Principal investigator, Industrial University of SantanderDiana Marina Camargo Lemos, M.Sc. Epid., Study chair, Industrial University of SantanderTania De Fatima Salvini, Ph.D, Study chair, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732017
- Sponsor's protocol ID
- 5612
- Status last verified
- Aug 2008
- First submitted
- 6 Aug 2008
- Last updated
- 11 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 2185495Cosgrove 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.
PubMed 1584856Taylor 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.
PubMed 9413451Taylor 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.
PubMed 1728050Fish 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.
PubMed 1946611Mendel 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.
PubMed 1508974Bettany 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.
PubMed 2315384Bettany 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.
PubMed 2375674Karnes 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.
PubMed 1584859Thornton 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.
PubMed 9555921Dolan 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.
PubMed 14608432Karnes 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.
PubMed 7717840Dolan 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.
PubMed 14737215Dolan 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.
PubMed 15970957Mohr 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.
PubMed 3499622
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of High Voltage Pulsed Current On Ankle Post-Traumatic Injuries
- ClinicalTrials.gov ID
- NCT00732017
- Acronym / sponsor ID
- 5612
- Conditions
- Ankle Sprain
- Keywords
- Sprain, Electric stimulation, Physical trauma, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad Industrial de SantanderUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HVPC- | Experimental | Device: high voltage pulse stimulation with negative polarityThis group received standard physical therapy treatment and HVPC with negative polarity. |
| CG | Active comparator | Other: standard physical therapy treatmentThe control group received only standard physical therapy treatment. |
| HVPC+ | Experimental | Device: Standard physical therapy and HVPC with positive polarityThis group received standard physical therapy treatment and HVPC using active electrodes with positive polarity. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard physical therapy and HVPC with positive polarityAlso: electrical stimulation, electrical currentA 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. | Device | HVPC+ |
| high voltage pulse stimulation with negative polarityAlso: electrical stimulation, electrical currentA 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. | Device | HVPC- |
| standard physical therapy treatmentAlso: standard care* 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 | CG |
Primary outcome
Pain with the visual analogue scale.
Time frame: The pain was measured before and at the end of the treatment.
3 secondary outcomes
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.
Edema was assessed with measures of ankle girth and volume.
Time frame: 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.
Time frame: The variables of gait were measured before and at the end of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2008.
- Background: PubMed 2185495Griffin 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.
- Background: PubMed 1584856Cosgrove 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.
- Background: PubMed 9413451Taylor 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.
- Background: PubMed 1728050Taylor 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.
- Background: PubMed 1946611Fish 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.
- Background: PubMed 1508974Mendel 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.
- Background: PubMed 2315384Bettany 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.
- Background: PubMed 2375674Bettany 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.
- Background: PubMed 1584859Karnes 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.
- Background: PubMed 9555921Thornton 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.
- Background: PubMed 14608432Dolan 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.
- Background: PubMed 7717840Karnes 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.
- Universidad Industrial de Santander - Home pageLink provided by the sponsor.
- Universidade Federal de Sao Carlos - Home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Cristina Sandoval Ortiz, M.Sc in P.T. principal investigator
Industrial University of Santander
Liliana Carolina Ramirez Ramirez, P.T. principal investigator
Industrial University of Santander
Diana Marina Camargo Lemos, M.Sc. Epid. study chair
Industrial University of Santander
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard physical therapy and HVPC with positive polarity, high voltage pulse stimulation with negative polarity and standard physical therapy treatment in people with Ankle Sprain, run by Universidad Industrial de Santander at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain with the visual analogue scale. (time frame: The pain was measured before and at the end of the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00732017, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2008.