Transcutaneous Electrical Nerve Stimulation and Interferential Currents in Chronic Low Back Pain
This study has been completed.
Sponsor:
Federal University of São Paulo
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
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Purpose
The purpose of this study was to compare the effects of the TENS and IFC in patients with non specific chronic low back pain.
| Condition | Intervention |
|---|---|
|
Chronic Low Back Pain |
Other: TENS Other: Interferential currents |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Federal University of São Paulo:
Primary Outcome Measures:
- Pain and Disability [ Time Frame: Before and after ten sessions (interventions groups) or ten days (control group) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 150 |
| Study Start Date: | March 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 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:
|
|
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 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:
|
|
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 Name: Transcutaneous electrical nervous stimulation
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided by Federal University of São Paulo
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | 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 |
| ClinicalTrials.gov Identifier: | NCT01017913 History of Changes |
| Other Study ID Numbers: | 0143/06 |
| Study First Received: | September 22, 2009 |
| Last Updated: | November 20, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
rehabilitation electrotherapy back pain |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013