Transcutaneous Electrical Nerve Stimulation and Interferential Currents in Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) in Patients With Non Specific Chronic Low Back Pain: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017913
• Other study ID #: 0143/06
• Status: Completed
• Phase: N/A
• First received: September 22, 2009
• Last updated: November 20, 2009
• Start date: March 2006
• Est. completion date: December 2007

Study information

• Verified date: November 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to compare the effects of the TENS and IFC in patients with non specific chronic low back pain.

Description:

Setting Outpatient physiotherapy department in university (Cesumar)

Participants A hundred and fifty patients with non specific chronic low back pain with or without radicular pain.

Interventions The patients were randomly divided into three groups: 1) TENS; 2) IFC; e 3) Control. Ten sessions of electrotherapy for groups 1 and 2, while the patients of the Control group stayed without any treatment in the same period

Main Outcome Measures Intensity of the pain through the Visual Analogue Scale and McGill Pain Questionnaire; specific functional disability by Roland Morris Disability Questionnaire; Analgesic period (hours); and the medication consumption

Statistic Analysis All data were analyzed using Statistica version 7 and SAS version 9.1. Baseline characteristics were compared using the Shapiro-Wilks test for continuous variables and then analysis of variance for measuring independent data. The characteristics of the patients who finished the treatment were compared with those of the lost patients, using one-way ANOVA and the Kruskal-Wallis test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Individuals who had had low back pain for less than three months

Exclusion Criteria:

• Individuals who were receiving treatment for their pain with another method at the same time, except for medicines;

• Pregnant women;

• Patients who had undergone vertebral column surgery (less than three months before the time of this study);

• Individuals with contraindications against electrotherapy, such as skin lesions, abnormal sensitivity, infectious and blood diseases, heart pacemakers or inability to answer questionnaires;

• Patients with fibromyalgia;

• Individuals with psychiatric problems;

• Individuals who refused to participate or were unwilling to follow a protocol lasting for two weeks.

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• TENS
The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms (standing in control number seven) with two channels.
• Interferential currents
The IFC was adjusted to a base frequency of 4000 Hz, with a modulation frequency range of 20 Hz, ?F of 10 Hz and slope of 1/1, in quadripolar mode.

Locations

Country	Name	City	State
Brazil	Cesumar	Maringá	Paraná

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Centro Universitario de Maringa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and Disability		Before and after ten sessions (interventions groups) or ten days (control group)	Yes
Secondary	Analgesic period (hours)and medication consumption		before and after ten sessions (interventions groups) or ten days (control group)	Yes