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

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

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
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

• 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

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 [ 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

• 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

Locations

Brazil

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

More Information

Additional Information:

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

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

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.

• 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
• 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:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations