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

This study has been completed.
Sponsor:
Collaborator:
Centro Universitario de Maringa
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01017913
First received: September 22, 2009
Last updated: November 20, 2009
Last verified: November 2009

September 22, 2009
November 20, 2009
March 2006
December 2006   (final data collection date for primary outcome measure)
Pain and Disability [ Time Frame: Before and after ten sessions (interventions groups) or ten days (control group) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01017913 on ClinicalTrials.gov Archive Site
Analgesic period (hours)and medication consumption [ Time Frame: before and after ten sessions (interventions groups) or ten days (control group) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Transcutaneous Electrical Nerve Stimulation and Interferential Currents in Chronic Low Back Pain
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Chronic Low Back Pain
  • 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 Name: 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:
    • IFC: intereferential currents
    • electrotherapy
  • Active Comparator: Electrotherapy equipment
    The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms with two channels.
    Interventions:
    • Other: TENS
    • Other: Interferential 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.
    Interventions:
    • Other: TENS
    • Other: Interferential currents
  • No Intervention: Control
    The patients of the Control group stayed without any treatment in the same period
    Intervention: Other: TENS
Facci LM, Nowotny JP, Tormem F, Trevisani VF. Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. Sao Paulo Med J. 2011;129(4):206-16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2007
December 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01017913
0143/06
No
Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) in patients with non specific chronic low back pain: randomized clinical trial, Unifesp/ Cesumar
Federal University of São Paulo
Centro Universitario de Maringa
Principal Investigator: Ligia M Facci Unifesp/ Cesumar
Federal University of São Paulo
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP