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Completed

NCT Number: NCT01017913

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cesumar

Maringá, Paraná, 87050390, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TENS

Other

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: Transcutaneous electrical nervous stimulation

Interferential currents

Other

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

Primary outcomes

  1. Pain and Disability

    Time frame: Before and after ten sessions (interventions groups) or ten days (control group)

Secondary outcomes

  1. Analgesic period (hours)and medication consumption

    Time frame: before and after ten sessions (interventions groups) or ten days (control group)

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Centro Universitario de Maringa

Registry information

Official study title

Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) in Patients With Non Specific Chronic Low Back Pain: Randomized Clinical Trial

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Nov 23, 2009
Registry last updated
Nov 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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