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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TENS
Interferential currents
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring rehabilitation, electrotherapy, back pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cesumar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Electrotherapy equipment

electrotherapy equipment

Control

Arm Description

The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms with two channels.

The CI was adjusted with 4000 HZ bases frequency, modulation frequency range 20 HZ, ∆F10 HZ, slope 1/1 and quadripolar manner.

The patients of the Control group stayed without any treatment in the same period

Outcomes

Primary Outcome Measures

Pain and Disability

Secondary Outcome Measures

Analgesic period (hours)and medication consumption

Full Information

First Posted
September 22, 2009
Last Updated
November 20, 2009
Sponsor
Federal University of São Paulo
Collaborators
Centro Universitario de Maringa
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1. Study Identification

Unique Protocol Identification Number
NCT01017913
Brief Title
Transcutaneous Electrical Nerve Stimulation and Interferential Currents in Chronic Low Back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo
Collaborators
Centro Universitario de Maringa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
rehabilitation, electrotherapy, back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrotherapy equipment
Arm Type
Active Comparator
Arm Description
The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms with two channels.
Arm Title
electrotherapy equipment
Arm Type
Active Comparator
Arm Description
The CI was adjusted with 4000 HZ bases frequency, modulation frequency range 20 HZ, ∆F10 HZ, slope 1/1 and quadripolar manner.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The patients of the Control group stayed without any treatment in the same period
Intervention Type
Other
Intervention Name(s)
TENS
Other Intervention Name(s)
Transcutaneous electrical nervous stimulation
Intervention Description
The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms (standing in control number seven) with two channels.
Intervention Type
Other
Intervention Name(s)
Interferential currents
Other Intervention Name(s)
IFC: intereferential currents, electrotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain and Disability
Time Frame
Before and after ten sessions (interventions groups) or ten days (control group)
Secondary Outcome Measure Information:
Title
Analgesic period (hours)and medication consumption
Time Frame
before and after ten sessions (interventions groups) or ten days (control group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ligia M Facci
Organizational Affiliation
Unifesp/ Cesumar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cesumar
City
Maringá
State/Province
Paraná
ZIP/Postal Code
87050390
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21971895
Citation
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.
Results Reference
derived

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

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