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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

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ClinicalTrials.gov Identifier: NCT01866332
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Luciola da Cunha Menezes Costa, Universidade Cidade de Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nonspecific Chronic Low Back Pain Other: Conventional Physical Therapy Device: Kinesio Tex Gold ( Kinesiotaping ) Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Conventional Physical Therapy
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
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 Names:
  • Manual therapy
  • Exercise therapy
  • Specific exercises
Experimental: Conventional Physical Therapy plus Kinesiotaping

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 Therapy
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 Names:
  • Manual therapy
  • Exercise therapy
  • Specific exercises

Device: Kinesio Tex Gold ( 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).
Other Names:
  • Bandages
  • Tape
  • Taping
  • Kinesio Tex
  • Kinesio Tape
  • Kinesiotape


Outcome Measures
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Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: Five weeks after randomization ]
    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  2. Disability [ Time Frame: Five weeks after randomization ]
    Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire


Secondary Outcome Measures :
  1. Pain Intensity [ Time Frame: 3 and 6 months after randomization ]
    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  2. Disability [ Time Frame: 3 and 6 months after randomization ]
    Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire

  3. Global impression of recovery [ Time Frame: 5 weeks, 3 and 6 months after randomization ]
    Global impression of recovery will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale


Other Outcome Measures:
  1. Satisfaction with care [ Time Frame: 5 weeks after randomization ]
    Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866332


Locations
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Brazil
Physical Therapy Outpatient Department
São Paulo, SP, Brazil, 03071000
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Investigators
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Principal Investigator: Luciola CM Costa, PhD Universidade Cidade de São Paulo
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Luciola da Cunha Menezes Costa, Associate Professor, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT01866332    
Other Study ID Numbers: FAPESP2013/02075-8
02075-8 ( Other Grant/Funding Number: FAPESP, Brazil )
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015
Keywords provided by Luciola da Cunha Menezes Costa, Universidade Cidade de Sao Paulo:
back pain
tape
chronic
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms