- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01017913
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
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Paraná
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Maringá, Paraná, Brazil, 87050390
- Cesumar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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:
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:
|
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.
|
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:
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:
|
NO_INTERVENTION: Control
The patients of the Control group stayed without any treatment in the same period
|
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:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Ligia M Facci, Unifesp/ Cesumar
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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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