Transcutaneous Electrical Nerve Stimulation and Interferential Currents in Chronic Low Back Pain
NCT ID: NCT01017913
Last Updated: 2009-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2006-03-31
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Electrotherapy equipment
The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms with two channels.
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.
electrotherapy equipment
The CI was adjusted with 4000 HZ bases frequency, modulation frequency range 20 HZ, ∆F10 HZ, slope 1/1 and quadripolar manner.
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.
Control
The patients of the Control group stayed without any treatment in the same period
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Centro Universitario de Maringa
OTHER
Federal University of São Paulo
OTHER
Responsible Party
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Unifesp/ Cesumar
Principal Investigators
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Ligia M Facci
Role: PRINCIPAL_INVESTIGATOR
Unifesp/ Cesumar
Locations
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Cesumar
Maringá, Paraná, Brazil
Countries
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References
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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. doi: 10.1590/s1516-31802011000400003.
Other Identifiers
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0143/06
Identifier Type: -
Identifier Source: org_study_id