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Is Kinesio Taping Able to Influence the Electrical Activity of Muscles in Patients With Low Back Pain?

Primary Purpose

Chronic Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kinesio Taping
Placebo
Sponsored by
Leandro Pires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Kinesio Taping, Low back Pain, Electromyographic, EMG

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with chronic low back pain (with a duration of at least 3 months), with or without leg pain.

Exclusion Criteria:

  • patients who have used the Kinesio Taping previously
  • any contraindications to the use of Kinesio Tex Gold®, such as allergy or severe skin problems.
  • patients with nerve root compromise
  • patients with fracture, tumor, inflammatory and/or infectious diseases
  • patients with severe cardiorespiratory and/or metabolic diseases
  • previous spinal surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    No Intervention

    Arm Label

    Kinesio Taping

    Placebo

    Control

    Arm Description

    Patients from this group will receive the kinesio Taping® Tex Gold tape according to the manufacturer's instructions. Kinesio Taping will be applied for the purpose of inhibiting the erector spinal muscle from the twelfth thoracic vertebrae (longissimus portion) up to the first sacral vertebrae with 10 to 15% tension (paper-OFF) in a "I" position bilaterally.

    Patient from this group will receive a 5cm-wide Micropore® tape from the twelfth thoracic vertebrae (longissimus portion) up to the first sacral vertebrae bilaterally.

    Patients allocated will not receive any intervention.

    Outcomes

    Primary Outcome Measures

    Median Force
    Median force (a measure of muscle activity) will be collected using surface electromyography.
    Root Mean Square
    Root Mean Square (a measure of muscle activity) will be collected using surface electromyography.

    Secondary Outcome Measures

    Pain Intensity
    This outcome will be measured using a 0-10 numerical rating scale ranging from "no pain" to "worse possible pain".

    Full Information

    First Posted
    April 25, 2016
    Last Updated
    April 29, 2016
    Sponsor
    Leandro Pires
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02759757
    Brief Title
    Is Kinesio Taping Able to Influence the Electrical Activity of Muscles in Patients With Low Back Pain?
    Official Title
    Is Kinesio Taping Able to Influence the Electrical Activity of Muscles in Patients With Low Back Pain? A Controlled Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    February 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Leandro Pires

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objectives: To test if the Kinesio Tex Gold ® is able to change the electromyographic signal of iliocostalis and longissimus muscles in patients with chronic nonspecific low back pain. Study design: Three-arm, randomized controlled trial with a blinded assessor. Location of study: Physical therapy Clinic of the Universidade Cidade de São Paulo (UNICID) Patients: Sixty-three patients with chronic nonspecific low back pain. Intervention: Patients allocated to the Kinesio Taping® group will receive the tape as described by the manufacturer's manual. The patients assigned to the placebo group will receive a Micropore tape and the control group will not receive any intervention. All groups will be assessed before and 30 minutes after intervention Measures: The following outcomes will be measured: 1) Muscle activity and 2) pain intensity. Limitations: Therapists will not be blinded.
    Detailed Description
    Patients who are seeking care for low back pain at the physiotherapy clinic from Universidade São Paulo will be invited to participate in the study and informed about the objectives of the study and evaluation procedures. Patients who agree to participate will sign a consent form. Patients will be assessed at baseline and immediately after the interventions. Investigators will collect data with regards to personal and anthropometric data, as well as pain intensity (measured by a 0-10 numerical rating scale in all follow up points) and disability (measured by the 0-24 point Roland Morris Disability Questionnaire at baseline only). Finally, muscle activation will be evaluated by surface electromyography and the maximum voluntary contraction of the trunk at 30 degrees position for a lumbar dynamometer that will be adjusted to the anthropometric profile of patients. The average and maximum values of muscular strength will be obtained by maximum voluntary contraction. The electromyography will capture the muscle activity in an integrated manner to electrogoniometers and will transmit the data via Bluetooth to a desktop with a MWX8 software (Biometrics) that will analyze the data. Before instrumentation patients will be instructed to perform the trunk extension movement the therapist's commands to become familiar with the equipment. Soon after will be held instrumentation (placement of electromyography electrodes and electrogoniometers and lumbar dynamometer) maximal voluntary contraction will be collected in trunk extension without Kinesio taping

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low Back Pain
    Keywords
    Kinesio Taping, Low back Pain, Electromyographic, EMG

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    63 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Kinesio Taping
    Arm Type
    Experimental
    Arm Description
    Patients from this group will receive the kinesio Taping® Tex Gold tape according to the manufacturer's instructions. Kinesio Taping will be applied for the purpose of inhibiting the erector spinal muscle from the twelfth thoracic vertebrae (longissimus portion) up to the first sacral vertebrae with 10 to 15% tension (paper-OFF) in a "I" position bilaterally.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patient from this group will receive a 5cm-wide Micropore® tape from the twelfth thoracic vertebrae (longissimus portion) up to the first sacral vertebrae bilaterally.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients allocated will not receive any intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Kinesio Taping
    Other Intervention Name(s)
    Kinesiology tape, Kinesio tape, Kinesiotaping
    Intervention Description
    This is a tape that can be placed in different parts of the body using different shapes and tensions. In theory, this tape can change muscle activity.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    A micropore tape will be used as placebo
    Primary Outcome Measure Information:
    Title
    Median Force
    Description
    Median force (a measure of muscle activity) will be collected using surface electromyography.
    Time Frame
    thirty minutes after interventions
    Title
    Root Mean Square
    Description
    Root Mean Square (a measure of muscle activity) will be collected using surface electromyography.
    Time Frame
    thirty minutes after interventions
    Secondary Outcome Measure Information:
    Title
    Pain Intensity
    Description
    This outcome will be measured using a 0-10 numerical rating scale ranging from "no pain" to "worse possible pain".
    Time Frame
    thirty minutes after interventions
    Other Pre-specified Outcome Measures:
    Title
    Disability
    Description
    Disability will be measured with a 0-24 Roland Morris Disability Questionnaire.
    Time Frame
    baseline only

    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: Patients with chronic low back pain (with a duration of at least 3 months), with or without leg pain. Exclusion Criteria: patients who have used the Kinesio Taping previously any contraindications to the use of Kinesio Tex Gold®, such as allergy or severe skin problems. patients with nerve root compromise patients with fracture, tumor, inflammatory and/or infectious diseases patients with severe cardiorespiratory and/or metabolic diseases previous spinal surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leonardo OP Costa, PhD
    Phone
    +551121781564
    Email
    Leonardo.costa@unicid.edu.br
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leandro G Pires, graduated
    Phone
    +5511974829627
    Email
    leandropires88@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leonardo OP Costa, PhD
    Organizational Affiliation
    Universidade Cidade de São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31866161
    Citation
    Pires LG, Padula RS, Junior MADL, Santos I, Almeida MO, Tomazoni SS, Costa LCM, Costa LOP. Can Kinesio Taping(R) influence the electromyographic signal intensity of trunk extensor muscles in patients with chronic low back pain? A randomized controlled trial. Braz J Phys Ther. 2020 Nov-Dec;24(6):539-549. doi: 10.1016/j.bjpt.2019.12.001. Epub 2019 Dec 15.
    Results Reference
    derived

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    Is Kinesio Taping Able to Influence the Electrical Activity of Muscles in Patients With Low Back Pain?

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