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

November 20, 2009 updated by: Federal University of São Paulo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraná
      • Maringá, Paraná, Brazil, 87050390
        • Cesumar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Electrotherapy equipment
The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms with two channels.
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.
Other Names:
  • Transcutaneous electrical nervous stimulation
Other: 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.
Other Names:
  • electrotherapy
  • IFC: intereferential currents
ACTIVE_COMPARATOR: electrotherapy equipment
The CI was adjusted with 4000 HZ bases frequency, modulation frequency range 20 HZ, ∆F10 HZ, slope 1/1 and quadripolar manner.
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.
Other Names:
  • Transcutaneous electrical nervous stimulation
Other: 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.
Other Names:
  • electrotherapy
  • IFC: intereferential currents
NO_INTERVENTION: Control
The patients of the Control group stayed without any treatment in the same period
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.
Other Names:
  • Transcutaneous electrical nervous stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain and Disability
Time Frame: Before and after ten sessions (interventions groups) or ten days (control group)
Before and after ten sessions (interventions groups) or ten days (control group)

Secondary Outcome Measures

Outcome Measure
Time Frame
Analgesic period (hours)and medication consumption
Time Frame: before and after ten sessions (interventions groups) or ten days (control group)
before and after ten sessions (interventions groups) or ten days (control group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Centro Universitario de Maringa

Investigators

  • Principal Investigator: Ligia M Facci, Unifesp/ Cesumar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (ESTIMATE)

November 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 23, 2009

Last Update Submitted That Met QC Criteria

November 20, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0143/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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