Neuromuscular Electrical Therapy in Venous Ulcers

Chronic Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372020
• Other study ID #: fepar-04
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2011
• Last updated: December 21, 2013
• Start date: February 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2013
• Source: Faculdade Evangelica do Parana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Varicose Ulcer
• Venous Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Brazil	Faculdade Dom Bosco	Curitiba	Parana

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade Evangelica do Parana

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain assessment will be performed by the Visual Analogue Scale	the subjects will be followed for a period of 4 weeks.	No
Secondary	ulcer area	the ulcer area will be measured by the planimetry.	the patients will be folloed for the 4-weeks.	No