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Completed

NCT Number: NCT01372020

Neuromuscular Electrical Therapy in Venous Ulcers

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.

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Key information

Conditions

Chronic Venous Insufficiency Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculdade Dom Bosco

Curitiba, Paraná, 55, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular electrical stimulation

Other

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

Primary outcomes

  1. Pain

    Time frame: the subjects will be followed for a period of 4 weeks.

    Pain assessment will be performed by the Visual Analogue Scale

Secondary outcomes

  1. ulcer area

    Time frame: the patients will be folloed for the 4-weeks.

    the ulcer area will be measured by the planimetry.

Sponsors and collaborators

Lead sponsor

Faculdade Evangelica do Parana

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 13, 2011
Registry last updated
Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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