Neuromuscular Electrical Therapy in Venous Ulcers

The Effect of Neuromuscular Electrical Therapy on Pain in Patients With Venous Ulcers: a Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Other: neuromuscular electrical stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Parana
    • Curitiba, Parana, Brazil, 55
      • Faculdade Dom Bosco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain assessment will be performed by the Visual Analogue Scale	the subjects will be followed for a period of 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ulcer area	the ulcer area will be measured by the planimetry.	the patients will be folloed for the 4-weeks.

Collaborators and Investigators

• Sponsor: Faculdade Evangelica do Parana
• Investigators: Principal Investigator: Korelo Raciele, M.sC, Facukdade Dom Bosco

Publications and helpful links

General Publications

• Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 10, 2011
• First Posted (Estimate): June 13, 2011

Study Record Updates

• Last Update Posted (Estimate): December 24, 2013
• Last Update Submitted That Met QC Criteria: December 21, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: electrical stimulation; wound healing; Varicose ulcer
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Varicose Ulcer; Venous Insufficiency
• Other Study ID Numbers: fepar-04