NCT02759757

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 3, 2016

Status Verified

April 1, 2016

Enrollment Period

5 months

First QC Date

April 25, 2016

Last Update Submit

April 29, 2016

Conditions

Chronic Low Back Pain

Keywords

Kinesio TapingLow back PainElectromyographicEMG

Outcome Measures

Primary Outcomes (2)

  • Median Force

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

    thirty minutes after interventions

  • Root Mean Square

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

    thirty minutes after interventions

Secondary Outcomes (1)

  • Pain Intensity

    thirty minutes after interventions

Other Outcomes (1)

  • Disability

    baseline only

Study Arms (3)

Kinesio Taping

EXPERIMENTAL

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.

Other: Kinesio Taping

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Control

NO INTERVENTION

Patients allocated will not receive any intervention.

Interventions

Kinesio TapingOTHER

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.

Also known as: Kinesiology tape, Kinesio tape, Kinesiotaping
Kinesio Taping
PlaceboOTHER

A micropore tape will be used as placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31866161DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Leonardo OP Costa, PhD

    Universidade Cidade de São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo OP Costa, PhD

CONTACT

+551121781564Leonardo.costa@unicid.edu.br

Leandro G Pires, graduated

CONTACT

+5511974829627leandropires88@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PT, masters student

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 3, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2016

Study Completion

February 1, 2017

Last Updated

May 3, 2016

Record last verified: 2016-04