Neuromuscular Electrical Therapy in Venous Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Silvia Valderramas, Faculdade Evangelica do Parana
ClinicalTrials.gov Identifier:
NCT01372020
First received: June 9, 2011
Last updated: December 21, 2013
Last verified: December 2013
  Purpose

The use of neuromuscular electrical stimulation in the treatment of venous ulcers with difficulty of repair could be an alternative therapeutic favoring devitalized tissues and hence the pain.

The aim of this study is to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency.


Condition Intervention Phase
Chronic Venous Insufficiency
Other: neuromuscular electrical stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Neuromuscular Electrical Therapy on Pain in Patients With Venous Ulcers: a Controlled Clinical Trial

Further study details as provided by Faculdade Evangelica do Parana:

Primary Outcome Measures:
  • Pain [ Time Frame: the subjects will be followed for a period of 4 weeks. ] [ Designated as safety issue: No ]
    Pain assessment will be performed by the Visual Analogue Scale


Secondary Outcome Measures:
  • ulcer area [ Time Frame: the patients will be folloed for the 4-weeks. ] [ Designated as safety issue: No ]
    the ulcer area will be measured by the planimetry.


Enrollment: 20
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: control group Other: neuromuscular electrical stimulation
The application technique used will be bipolar, with electrodes of the type metal-tipped pen. The electrodes will be placed at the outer edges of the ulcer, on opposite sides of the same and the estimated time of 1 minute at each point. All the edge of the ulcer will be bypassed, thereby separating the injections every 1 cm, returning to the starting point at the end of the application. To ensure that the entire edge of the ulcer to receive the stimulation, the end points of the application, the application will be made ​​for another minute sliding the pen around the whole edge. Thus the application time will be directly proportional to the ulcer area. The subjects will be received 10 applications, three times a week for a period of 4 weeks.
Other Name: intervention group
Experimental: neuromuscular electrical therapy Other: neuromuscular electrical stimulation
The application technique used will be bipolar, with electrodes of the type metal-tipped pen. The electrodes will be placed at the outer edges of the ulcer, on opposite sides of the same and the estimated time of 1 minute at each point. All the edge of the ulcer will be bypassed, thereby separating the injections every 1 cm, returning to the starting point at the end of the application. To ensure that the entire edge of the ulcer to receive the stimulation, the end points of the application, the application will be made ​​for another minute sliding the pen around the whole edge. Thus the application time will be directly proportional to the ulcer area. The subjects will be received 10 applications, three times a week for a period of 4 weeks.
Other Name: intervention group

Detailed Description:

The aim was to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency. In a simple-blind controlled clinical study, 20 subjects with venous ulcers with age over 50 years will be divided in two groups:neuromuscular electrical stimulation(n=10) and control group (n=10). Pain (by Visual Analogue Scale) and the ulcer area (by planimetry on graph paper and the software ImageJ ®) were measured.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of both genders
  • aged over 50 years
  • sedentary and with clinical diagnosis of chronic venous insufficiency with ulcer in lower limbs will be included

Exclusion Criteria:

  • Subjects with pacemakers
  • diabetes
  • uncontrolled hypertension
  • osteomyelitis and pain of unknown origin
  • unable to walk or make use of drugs that acted directly on the healing process will be excluded
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01372020

Locations
Brazil
Faculdade Dom Bosco
Curitiba, Parana, Brazil, 55
Sponsors and Collaborators
Faculdade Evangelica do Parana
Investigators
Principal Investigator: Korelo Raciele, M.sC Facukdade Dom Bosco
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Silvia Valderramas, Faculdade Evangelica do Parana
ClinicalTrials.gov Identifier: NCT01372020     History of Changes
Other Study ID Numbers: fepar-04
Study First Received: June 9, 2011
Last Updated: December 21, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Faculdade Evangelica do Parana:
Varicose ulcer
wound healing
electrical stimulation

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Venous Insufficiency
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014