Neuromuscular Electrical Therapy in Venous Ulcers
Primary Purpose
Chronic Venous Insufficiency
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
neuromuscular electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency focused on measuring Varicose ulcer, wound healing, electrical stimulation
Eligibility 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
Sites / Locations
- Faculdade Dom Bosco
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
control group
neuromuscular electrical therapy
Arm Description
Outcomes
Primary Outcome Measures
Pain
Pain assessment will be performed by the Visual Analogue Scale
Secondary Outcome Measures
ulcer area
the ulcer area will be measured by the planimetry.
Full Information
NCT ID
NCT01372020
First Posted
June 9, 2011
Last Updated
December 21, 2013
Sponsor
Faculdade Evangelica do Parana
1. Study Identification
Unique Protocol Identification Number
NCT01372020
Brief Title
Neuromuscular Electrical Therapy in Venous Ulcers
Official Title
The Effect of Neuromuscular Electrical Therapy on Pain in Patients With Venous Ulcers: a Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade Evangelica do Parana
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
Keywords
Varicose ulcer, wound healing, electrical stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Sham Comparator
Arm Title
neuromuscular electrical therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
neuromuscular electrical stimulation
Other Intervention Name(s)
intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
Pain assessment will be performed by the Visual Analogue Scale
Time Frame
the subjects will be followed for a period of 4 weeks.
Secondary Outcome Measure Information:
Title
ulcer area
Description
the ulcer area will be measured by the planimetry.
Time Frame
the patients will be folloed for the 4-weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korelo Raciele, M.sC
Organizational Affiliation
Facukdade Dom Bosco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade Dom Bosco
City
Curitiba
State/Province
Parana
ZIP/Postal Code
55
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
3893385
Citation
Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.
Results Reference
result
PubMed Identifier
22990161
Citation
Korelo RI, Valderramas S, Ternoski B, Medeiros DS, Andres LF, Adolph SM. Microcurrent application as analgesic treatment in venous ulcers: a pilot study. Rev Lat Am Enfermagem. 2012 Jul-Aug;20(4):753-60. doi: 10.1590/s0104-11692012000400016. English, Portuguese, Spanish.
Results Reference
derived
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Neuromuscular Electrical Therapy in Venous Ulcers
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