Effectiveness of Transcutaneous Electrical Nerve Stimulation in Patients With Acute Low Back Pain

April 22, 2015 updated by: Vaneska da Graça Cruz Martinelli Lourenzi, Federal University of São Paulo

Introduction: Low back pain is one of the most common complaints in doctors' offices, and acute low back pain is characterized by episodes of pain with less than three weeks duration. The transcutaneous electrical nerve stimulation (TENS), based on the gate control theory of pain proposed by Melzack and Wall in 1965, has been used as an adjunctive therapy in the control of back pain, being a non-invasive, low cost, safe and easy to apply. No studies were found regarding the effectiveness of TENS in acute low back pain.

Objective: To evaluate the effectiveness of TENS in pain management of patients with acute low back pain.

Material and Methods: A randomized clinical trial, double-blinded and placebo-controlled. Patients were selected in the clinics of Federal de University of Sao Paulo (UNIFESP) according to the following criteria: acute low back pain, both genders, aged between 18 and 65 years, pain between 4 and 8cm in pain numeric scale (PNS) and who agreed to participate in the study. After signing the informed consent patients were randomly allocated into one of the groups: TENS group (TG) or Placebo Group (PG). In TG was applied conventional TENS with frequency and intensity variation (FIV) effect, frequency of 100 hertz, a pulse width of 60μs and intensity adjusted according to the individual baseline for each patient without causing muscular contraction. The electrodes were arranged in a cross shape in the paravertebral region (levels T12-L1 and L5 - S1). In PG the same procedures were adopted, but did not occur electrical stimulus. Patients were informed that they could or could not feel electric shocks. Treatment consisted of 10 sessions (2x / week / 5 weeks), with each session lasting 30 '. Assessments were made at the following times: T0 (baseline), T1 to T10 (the beginning and end of each session), T11 (after the last session), T30 (30 days after the last session) and T60 (60 days after the last session). Assessment tools: PNS for pain, short-form 36 (SF-36), Roland-Morris, self-assessment of improvement ("Likert" scale) and drug consumption (daily).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acute low back pain
  • both genders
  • aged between 18 and 65 years
  • pain between 4 and 8cm in PNS (pain numeric scale)
  • who agreed to participate in the study.

Exclusion Criteria:

  • Patients with pain of inflammatory, neoplastic or infectious origin,
  • with cardiac pacemaker,
  • previous back surgery,
  • signs of irritation of nerve roots,
  • vertebral fracture, which changed the physical activity in the last three months,
  • and pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS group
It was applied conventional TENS with FIV effect, frequency of 100 Hertz, a pulse width of 60μs and intensity adjusted according to the individual baseline for each patient without causing muscular contraction. The electrodes were arranged in a cross shape in the paravertebral region (levels T12-L1 and L5 - S1). Treatment consisted of 10 sessions (2x / week / 5 weeks), with each session lasting 30 '.
Device: TENS
Placebo Comparator: Placebo group
In Placebo group the same procedures of the TENS group were adopted, but did not occur electrical stimulus.
Device: TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pain assessed by visual analog scale
Time Frame: Baseline; 1,2,3,4,5,6,7,8,9,10; 30 and 60 days
Baseline; 1,2,3,4,5,6,7,8,9,10; 30 and 60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in functional capacity assessed by the Roland Morris questionnaire
Time Frame: Baseline; 10; 30 and 60 days
Baseline; 10; 30 and 60 days
Change in self-assessment of improvement assessed by a likert scale
Time Frame: Baseline; 10; 30 and 60 days
Baseline; 10; 30 and 60 days
Change in Quality of life assessed by the SF-36 questionnaire
Time Frame: Baseline; 10; 30 and 60 days
Baseline; 10; 30 and 60 days
Change in Drug consumption assessed by the number of NSAIDs consumed
Time Frame: Baseline; 10; 30 and 60 days
Baseline; 10; 30 and 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Vaneska GC Lourenzi, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 1308/09

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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