NCT03463200

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

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

March 5, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

March 5, 2018

Last Update Submit

May 3, 2018

Conditions

Keywords

bandagelow back painmuscle fatigueelectromyography

Outcome Measures

Primary Outcomes (1)

  • Median frequency

    Median frequency slope measured my electromyography

    Change from baseline median frequency at three days after the application of the tape.

Secondary Outcomes (3)

  • Median frequency

    Change from baseline median frequency at ten days after the application of the tape.

  • Sustained muscle fatigue time

    Change from baseline sustained time at three days after the application of the tape.

  • Sustained muscle fatigue time

    Change from baseline sustained time at ten days after the application of the tape.

Study Arms (4)

Control group

NO INTERVENTION

It will not apply any tape.

Experimental group 1

EXPERIMENTAL

Apply the KT with tension in the erector spine muscles.

Other: Functional elastic tape tensioned

Experimental group 2

EXPERIMENTAL

Apply the KT without tension in the erector spine muscles.

Other: Functional elastic tape non-tensioned

Experimental group 3

EXPERIMENTAL

Apply Micropore tape in the erector spine muscles.

Other: Rigid Tape

Interventions

Application of Kinesio Taping with tension in the erector spine muscles.

Also known as: Kinesio Taping with tension
Experimental group 1

Application of Kinesio Taping without tension in the erector spine muscles.

Also known as: Kinesio Taping without tension
Experimental group 2

Application of Micropore tape in the erector spine muscles.

Also known as: Micropore Tape
Experimental group 3

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59140-840, Brazil

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Jamilson S Brasileiro, Professor

CONTACT

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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Researcher

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 13, 2018

Study Start

March 5, 2018

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

May 4, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations