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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02759757
• Other study ID #: pires1904
• Status: Not yet recruiting
• Phase: N/A
• First received: April 25, 2016
• Last updated: April 29, 2016
• Start date: May 2016
• Est. completion date: February 2017

Study information

• Verified date: April 2016
• Source: Universidade Cidade de Sao Paulo
• Contact: Leonardo OP Costa, PhD
• Phone: +551121781564
• Email: Leonardo.costa[@]unicid.edu.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Kinesio Taping
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.
• Placebo
A micropore tape will be used as placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Leandro Pires

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disability	Disability will be measured with a 0-24 Roland Morris Disability Questionnaire.	baseline only	No
Primary	Median Force	Median force (a measure of muscle activity) will be collected using surface electromyography.	thirty minutes after interventions	No
Primary	Root Mean Square	Root Mean Square (a measure of muscle activity) will be collected using surface electromyography.	thirty minutes after interventions	No
Secondary	Pain Intensity	This outcome will be measured using a 0-10 numerical rating scale ranging from "no pain" to "worse possible pain".	thirty minutes after interventions	No