- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02759757
Is Kinesio Taping Able to Influence the Electrical Activity of Muscles in Patients With Low Back Pain?
Is Kinesio Taping Able to Influence the Electrical Activity of Muscles in Patients With Low Back Pain? A Controlled Randomized Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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 |
|---|---|
|
Experimental: Kinesio Taping
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.
|
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.
Other Names:
|
|
Placebo Comparator: Placebo
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.
|
A micropore tape will be used as placebo
|
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No Intervention: Control
Patients allocated will not receive any intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Median Force
Time Frame: thirty minutes after interventions
|
Median force (a measure of muscle activity) will be collected using surface electromyography.
|
thirty minutes after interventions
|
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Root Mean Square
Time Frame: thirty minutes after interventions
|
Root Mean Square (a measure of muscle activity) will be collected using surface electromyography.
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thirty minutes after interventions
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: thirty minutes after interventions
|
This outcome will be measured using a 0-10 numerical rating scale ranging from "no pain" to "worse possible pain".
|
thirty minutes after interventions
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability
Time Frame: baseline only
|
Disability will be measured with a 0-24 Roland Morris Disability Questionnaire.
|
baseline only
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- pires1904
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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