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

NCT ID: NCT01866332

Last Updated: 2015-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-12-31

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.

Conditions

Nonspecific Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type: OTHER

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).

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).

Group Type: EXPERIMENTAL

Conventional Physical Therapy

Intervention Type: OTHER

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).

Kinesio Tex Gold ( Kinesiotaping )

Intervention Type: DEVICE

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).

Interventions

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 Type: OTHER

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).

Intervention Type: DEVICE

Other Intervention Names

Manual therapy; Exercise therapy; Specific exercises; Bandages; Tape; Taping; Kinesio Tex; Kinesio Tape; Kinesiotape

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Luciola da Cunha Menezes Costa

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciola CM Costa, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de São Paulo

Locations

Physical Therapy Outpatient Department

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 27266883 (View on PubMed)

Related Links

http://www.bv.fapesp.br/pt/pesquisador/665136/luciola-da-cunha-menezes-costa/

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

Other Identifiers

02075-8

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FAPESP2013/02075-8

Identifier Type: -

Identifier Source: org_study_id