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KT on Low Back Pain Patients

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Functional elastic tape tensioned
Functional elastic tape non-tensioned
Rigid Tape
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring bandage, low back pain, muscle fatigue, electromyography

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female between 18 and 50 years of age with chronic nonspecific low back pain for more than three months.

Exclusion Criteria:

  • Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
  • Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
  • Fibromyalgia
  • Corticosteroid treatment in the previous two weeks;
  • Antiinflammatory treatment in the previous 24 hours;
  • Contraindications to the use of Kinesio Taping (allergy or intolerance);
  • Score of two or less on Visual Analogue Scale of the first day;
  • Pregnancy;
  • Previous Kinesio Tape therapy on lumbar.

Sites / Locations

  • Federal University of Rio Grande do NorteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control group

Experimental group 1

Experimental group 2

Experimental group 3

Arm Description

It will not apply any tape.

Apply the KT with tension in the erector spine muscles.

Apply the KT without tension in the erector spine muscles.

Apply Micropore tape in the erector spine muscles.

Outcomes

Primary Outcome Measures

Median frequency
Median frequency slope measured my electromyography

Secondary Outcome Measures

Median frequency
Median frequency slope measured my electromyography
Sustained muscle fatigue time
Sustained time during a fatigue test
Sustained muscle fatigue time
Sustained time during a fatigue test

Full Information

First Posted
March 5, 2018
Last Updated
May 3, 2018
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03463200
Brief Title
KT on Low Back Pain Patients
Official Title
The Influence of Kinesio Taping on Back Muscle Fatigue of Low Back Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aim evaluates the effect of Kinesio Taping (KT) on back muscle fatigue of low back pain patients, analysing the electromyography activity of longissimus muscle (median frequency) and the sustained time during a fatigue test (Ito test).
Detailed Description
Individuals with low back pain usually have poor back muscles endurance, which may be improved with the application of Kinesio Taping. The aim of this study is evaluate the effect of Kinesio Taping on back muscle fatigue of low back pain patients. Sixty-four women, between 18 to 50 years old, with chronic nonspecific Low Back Pain will attend this study. They will be randomly assigned in four different groups: control group (CG), KT with tension group (KTT), KT no tension group (KTNT) and Micropore® group (MP) and submitted to three evaluations: pre, three and ten days after intervention, analysing the electromyography activity of longissimus muscle and the sustained time during a fatigue test. The variables analysed during the evaluations will be median frequency (MP) slope of longuissimus muscle and sustained time during the Ito test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
bandage, low back pain, muscle fatigue, electromyography

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
It will not apply any tape.
Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
Apply the KT with tension in the erector spine muscles.
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
Apply the KT without tension in the erector spine muscles.
Arm Title
Experimental group 3
Arm Type
Experimental
Arm Description
Apply Micropore tape in the erector spine muscles.
Intervention Type
Other
Intervention Name(s)
Functional elastic tape tensioned
Other Intervention Name(s)
Kinesio Taping with tension
Intervention Description
Application of Kinesio Taping with tension in the erector spine muscles.
Intervention Type
Other
Intervention Name(s)
Functional elastic tape non-tensioned
Other Intervention Name(s)
Kinesio Taping without tension
Intervention Description
Application of Kinesio Taping without tension in the erector spine muscles.
Intervention Type
Other
Intervention Name(s)
Rigid Tape
Other Intervention Name(s)
Micropore Tape
Intervention Description
Application of Micropore tape in the erector spine muscles.
Primary Outcome Measure Information:
Title
Median frequency
Description
Median frequency slope measured my electromyography
Time Frame
Change from baseline median frequency at three days after the application of the tape.
Secondary Outcome Measure Information:
Title
Median frequency
Description
Median frequency slope measured my electromyography
Time Frame
Change from baseline median frequency at ten days after the application of the tape.
Title
Sustained muscle fatigue time
Description
Sustained time during a fatigue test
Time Frame
Change from baseline sustained time at three days after the application of the tape.
Title
Sustained muscle fatigue time
Description
Sustained time during a fatigue test
Time Frame
Change from baseline sustained time at ten days after the application of the tape.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female between 18 and 50 years of age with chronic nonspecific low back pain for more than three months. Exclusion Criteria: Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis); Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others); Fibromyalgia Corticosteroid treatment in the previous two weeks; Antiinflammatory treatment in the previous 24 hours; Contraindications to the use of Kinesio Taping (allergy or intolerance); Score of two or less on Visual Analogue Scale of the first day; Pregnancy; Previous Kinesio Tape therapy on lumbar.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamilson S Brasileiro, Professor
Phone
+55 84 3342-2015
Email
brasileiro@ufrnet.br
Facility Information:
Facility Name
Federal University of Rio Grande do Norte
City
Natal
State/Province
RN
ZIP/Postal Code
59140-840
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamilson S Brasileiro, PhD
Phone
+55 84 3342-2008
Email
brasileiro@ufrnet.br

12. IPD Sharing Statement

Plan to Share IPD
No

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KT on Low Back Pain Patients

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