- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03463200
KT on Low Back Pain Patients
May 3, 2018 updated by: Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
The Influence of Kinesio Taping on Back Muscle Fatigue of Low Back Pain Patients
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RN
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Natal, RN, Brazil, 59140-840
- Recruiting
- Federal University of Rio Grande do Norte
-
Contact:
- Jamilson S Brasileiro, PhD
- Phone Number: +55 84 3342-2008
- Email: brasileiro@ufrnet.br
-
-
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 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
It will not apply any tape.
|
|
|
Experimental: Experimental group 1
Apply the KT with tension in the erector spine muscles.
|
Application of Kinesio Taping with tension in the erector spine muscles.
Other Names:
|
|
Experimental: Experimental group 2
Apply the KT without tension in the erector spine muscles.
|
Application of Kinesio Taping without tension in the erector spine muscles.
Other Names:
|
|
Experimental: Experimental group 3
Apply Micropore tape in the erector spine muscles.
|
Application of Micropore tape in the erector spine muscles.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Median frequency
Time Frame: Change from baseline median frequency at three days after the application of the tape.
|
Median frequency slope measured my electromyography
|
Change from baseline median frequency at three days after the application of the tape.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Median frequency
Time Frame: Change from baseline median frequency at ten days after the application of the tape.
|
Median frequency slope measured my electromyography
|
Change from baseline median frequency at ten days after the application of the tape.
|
|
Sustained muscle fatigue time
Time Frame: Change from baseline sustained time at three days after the application of the tape.
|
Sustained time during a fatigue test
|
Change from baseline sustained time at three days after the application of the tape.
|
|
Sustained muscle fatigue time
Time Frame: Change from baseline sustained time at ten days after the application of the tape.
|
Sustained time during a fatigue test
|
Change from baseline sustained time at ten days after the application of the tape.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
March 5, 2018
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
March 5, 2018
First Submitted That Met QC Criteria
March 9, 2018
First Posted (Actual)
March 13, 2018
Study Record Updates
Last Update Posted (Actual)
May 4, 2018
Last Update Submitted That Met QC Criteria
May 3, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LBM2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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