Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 28, 2013
First Posted Date  ICMJE May 31, 2013
Last Update Posted Date January 15, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
  • Pain Intensity [ Time Frame: Five weeks after randomization ]
    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
  • Disability [ Time Frame: Five weeks after randomization ]
    Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 30, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nonspecific Chronic Low Back Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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).
    Intervention: Other: Conventional Physical Therapy
  • 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).

    Interventions:
    • Other: Conventional Physical Therapy
    • Device: Kinesio Tex Gold ( Kinesiotaping )
Publications * Added MA, Costa LO, de Freitas DG, Fukuda TY, Monteiro RL, Salomão 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2013)
148
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01866332
Other Study ID Numbers  ICMJE FAPESP2013/02075-8
02075-8 ( Other Grant/Funding Number: FAPESP, Brazil )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Luciola da Cunha Menezes Costa, Universidade Cidade de Sao Paulo
Study Sponsor  ICMJE Universidade Cidade de Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luciola CM Costa, PhD Universidade Cidade de São Paulo
PRS Account Universidade Cidade de Sao Paulo
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP