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Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain

Primary Purpose

Nonspecific Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Conventional Physical Therapy
Kinesio Tex Gold ( Kinesiotaping )
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonspecific Chronic Low Back Pain focused on measuring back pain, tape, chronic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Physical Therapy Outpatient Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Physical Therapy

Conventional Physical Therapy plus Kinesiotaping

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Pain Intensity
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire

Secondary Outcome Measures

Pain Intensity
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire
Global impression of recovery
Global impression of recovery will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale

Full Information

First Posted
May 28, 2013
Last Updated
January 14, 2015
Sponsor
Universidade Cidade de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01866332
Brief Title
Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain
Official Title
Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
One hundred and forty-eight patients will be randomized to receive either conventional physical therapy, which consist of a combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization (Conventional Physical Therapy Group) or to receive conventional physical therapy plus the addition of the Kinesio Taping in the lumbar spine (Conventional Physical Therapy plus Kinesio Taping), over a period of 5 weeks (10 sessions of treatment). Clinical outcomes (pain intensity, disability and global perceived effect ) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. Data will be collected by a blinded examiner who will be unaware about the group allocation. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonspecific Chronic Low Back Pain
Keywords
back pain, tape, chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physical Therapy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Conventional Physical Therapy plus Kinesiotaping
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Other Intervention Name(s)
Manual therapy, Exercise therapy, Specific exercises
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Kinesio Tex Gold ( Kinesiotaping )
Other Intervention Name(s)
Bandages, Tape, Taping, Kinesio Tex, Kinesio Tape, Kinesiotape
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Time Frame
Five weeks after randomization
Title
Disability
Description
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire
Time Frame
Five weeks after randomization
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Time Frame
3 and 6 months after randomization
Title
Disability
Description
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire
Time Frame
3 and 6 months after randomization
Title
Global impression of recovery
Description
Global impression of recovery will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale
Time Frame
5 weeks, 3 and 6 months after randomization
Other Pre-specified Outcome Measures:
Title
Satisfaction with care
Description
Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care
Time Frame
5 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with non-specific low back pain longer than 12 weeks Seeking care for low back pain Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciola CM Costa, PhD
Organizational Affiliation
Universidade Cidade de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy Outpatient Department
City
São Paulo
State/Province
SP
ZIP/Postal Code
03071000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27266883
Citation
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.
Results Reference
derived
Links:
URL
http://www.bv.fapesp.br/pt/pesquisador/665136/luciola-da-cunha-menezes-costa/
Description
Info from the grant sponsor of this study (FAPESP, Brazil)

Learn more about this trial

Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain

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