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

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

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.

Study Overview

• Status: Completed
• Conditions: Nonspecific Chronic Low Back Pain
• Intervention / Treatment: Other: Conventional Physical Therapy; Device: Kinesio Tex Gold ( Kinesiotaping )

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: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 03071000
      • Physical Therapy Outpatient Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Exercise therapy; Manual 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: Exercise therapy; Manual 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: Kinesiotape; Kinesio Tape; Taping; Tape; Bandages; Kinesio Tex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)	3 and 6 months after randomization
Disability	Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire	3 and 6 months after randomization
Global impression of recovery	Global impression of recovery will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale	5 weeks, 3 and 6 months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with care	Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care	5 weeks after randomization

Collaborators and Investigators

• Sponsor: Universidade Cidade de Sao Paulo
• Investigators: Principal Investigator: Luciola CM Costa, PhD, Universidade Cidade de Sao Paulo

Publications and helpful links

General Publications

• 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.

Helpful Links

• Info from the grant sponsor of this study (FAPESP, Brazil)

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 14, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: back pain; chronic; tape
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: FAPESP2013/02075-8; 02075-8 (Other Grant/Funding Number: FAPESP, Brazil)