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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427425
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
Vaneska da Graça Cruz Martinelli Lourenzi, Federal University of São Paulo

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Low Back Pain Device: TENS Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in functional capacity assessed by the Roland Morris questionnaire [ Time Frame: Baseline; 10; 30 and 60 days ]
  2. Change in self-assessment of improvement assessed by a likert scale [ Time Frame: Baseline; 10; 30 and 60 days ]
  3. Change in Quality of life assessed by the SF-36 questionnaire [ Time Frame: Baseline; 10; 30 and 60 days ]
  4. Change in Drug consumption assessed by the number of NSAIDs consumed [ Time Frame: Baseline; 10; 30 and 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427425


Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Vaneska GC Lourenzi Federal University of São Paulo
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Responsible Party: Vaneska da Graça Cruz Martinelli Lourenzi, Physiotherapist, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02427425    
Other Study ID Numbers: CEP 1308/09
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015
Keywords provided by Vaneska da Graça Cruz Martinelli Lourenzi, Federal University of São Paulo:
Transcutaneous Electric Nerve Stimulation
Pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms