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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
  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:
  • IFC: intereferential currents
  • electrotherapy
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:
  • IFC: intereferential currents
  • electrotherapy
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017913

Locations
Brazil
Cesumar
Maringá, Paraná, Brazil, 87050390
Sponsors and Collaborators
Federal University of São Paulo
Centro Universitario de Maringa
Investigators
Principal Investigator: Ligia M Facci Unifesp/ Cesumar
  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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014