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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

Sponsor
Universidade Cidade de Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01866332
Collaborator
(none)
148
Enrollment
1
Location
2
Arms
18
Duration (Months)
8.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Conventional Physical Therapy
  • Device: Kinesio Tex Gold ( Kinesiotaping )
 N/A

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

Study Type:
Interventional
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 :
Jun 1, 2013
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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

    Primary Outcome Measures

    1. Pain Intensity [Five weeks after randomization]

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

    2. Disability [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 [3 and 6 months after randomization]

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

    2. Disability [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 [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 [5 weeks after randomization]

      Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Physical Therapy Outpatient Department São Paulo SP Brazil 03071000

    Sponsors and Collaborators

    • Universidade Cidade de Sao Paulo

    Investigators

    • Principal Investigator: Luciola CM Costa, PhD, Universidade Cidade de São Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    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
    First Posted:
    May 31, 2013
    Last Update Posted:
    Jan 15, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Luciola da Cunha Menezes Costa, Associate Professor, Universidade Cidade de Sao Paulo
    back pain
    tape
    chronic
    Additional relevant MeSH terms:
    Back Pain
    Low Back Pain

    Study Results

    No Results Posted as of Jan 15, 2015