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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
TENS
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Transcutaneous Electric Nerve Stimulation, Pain

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    TENS group

    Placebo group

    Arm Description

    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 '.

    In Placebo group the same procedures of the TENS group were adopted, but did not occur electrical stimulus.

    Outcomes

    Primary Outcome Measures

    Change in pain assessed by visual analog scale

    Secondary Outcome Measures

    Change in functional capacity assessed by the Roland Morris questionnaire
    Change in self-assessment of improvement assessed by a likert scale
    Change in Quality of life assessed by the SF-36 questionnaire
    Change in Drug consumption assessed by the number of NSAIDs consumed

    Full Information

    First Posted
    March 10, 2015
    Last Updated
    April 22, 2015
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02427425
    Brief Title
    Effectiveness of Transcutaneous Electrical Nerve Stimulation in Patients With Acute Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    Transcutaneous Electric Nerve Stimulation, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    71 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TENS group
    Arm Type
    Experimental
    Arm Description
    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 '.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    In Placebo group the same procedures of the TENS group were adopted, but did not occur electrical stimulus.
    Intervention Type
    Device
    Intervention Name(s)
    TENS
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Change in functional capacity assessed by the Roland Morris questionnaire
    Time Frame
    Baseline; 10; 30 and 60 days
    Title
    Change in self-assessment of improvement assessed by a likert scale
    Time Frame
    Baseline; 10; 30 and 60 days
    Title
    Change in Quality of life assessed by the SF-36 questionnaire
    Time Frame
    Baseline; 10; 30 and 60 days
    Title
    Change in Drug consumption assessed by the number of NSAIDs consumed
    Time Frame
    Baseline; 10; 30 and 60 days

    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: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vaneska GC Lourenzi
    Organizational Affiliation
    Federal University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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