NCT01866332

Brief Summary

The purpose of this study is to determine the effectiveness of the addition of the use of Kinesio Taping in patients with chronic nonspecific low back pain who receive conventional physical therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

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

May 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

1.4 years

First QC Date

May 28, 2013

Last Update Submit

January 14, 2015

Conditions

Keywords

back paintapechronic

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity

    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

    Five weeks after randomization

  • Disability

    Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire

    Five weeks after randomization

Secondary Outcomes (3)

  • Pain Intensity

    3 and 6 months after randomization

  • Disability

    3 and 6 months after randomization

  • Global impression of recovery

    5 weeks, 3 and 6 months after randomization

Other Outcomes (1)

  • Satisfaction with care

    5 weeks after randomization

Study Arms (2)

Conventional Physical Therapy

ACTIVE COMPARATOR

Combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). The treatment will be tailored to the patient presentation (i.e. pragmatic treatment).

Other: Conventional Physical Therapy

Conventional Physical Therapy plus Kinesiotaping

EXPERIMENTAL

Patients will receive conventional physical therapy plus an application of Kinesiotaping in their lumbar spine. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).

Other: Conventional Physical TherapyDevice: Kinesio Tex Gold ( Kinesiotaping )

Interventions

Combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). The treatment will be tailored to the patient presentation (i.e. pragmatic treatment).

Also known as: Manual therapy, Exercise therapy, Specific exercises
Conventional Physical TherapyConventional Physical Therapy plus Kinesiotaping

Kinesiotaping intervention is based upon the use of specific elastic tapes (known as Kinesio Tex Gold) that are applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position. The tapes will be placed over the superficial back muscles (erector spinae muscles).

Also known as: Bandages, Tape, Taping, Kinesio Tex, Kinesio Tape, Kinesiotape
Conventional Physical Therapy plus Kinesiotaping

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with non-specific low back pain longer than 12 weeks
  • Seeking care for low back pain

You may not qualify if:

  • Contra indications to physical exercise
  • Serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases)
  • Nerve root compromise
  • Contra indications to the Kinesio Taping (e.g. intolerance to tapes, band aids etc)
  • Pregnancy
  • Severe cardiorespiratory conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy Outpatient Department

São Paulo, São Paulo, 03071000, Brazil

Location

Related Publications (1)

  • Added MA, Costa LO, de Freitas DG, Fukuda TY, Monteiro RL, Salomao EC, de Medeiros FC, Costa Lda C. Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Jul;46(7):506-13. doi: 10.2519/jospt.2016.6590. Epub 2016 Jun 6.

Related Links

MeSH Terms

Conditions

Back PainBronchiolitis Obliterans Syndrome

Interventions

Musculoskeletal ManipulationsExercise TherapyBandagesAthletic Tape

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationAftercareContinuity of Patient CarePatient CareEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Luciola CM Costa, PhD

    Universidade Cidade de São Paulo

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

May 28, 2013

First Posted

May 31, 2013

Study Start

June 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations