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

Nonspecific Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866332
• Other study ID #: FAPESP2013/02075-8
• Secondary ID: 02075-8
• Status: Completed
• Phase: N/A
• First received: May 28, 2013
• Last updated: January 14, 2015
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Nonspecific Chronic Low Back Pain

Intervention

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).

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).

Locations

Country	Name	City	State
Brazil	Physical Therapy Outpatient Department	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with care	Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care	5 weeks after randomization	No
Primary	Pain Intensity	Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)	Five weeks after randomization	No
Primary	Disability	Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire	Five weeks after randomization	No
Secondary	Pain Intensity	Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)	3 and 6 months after randomization	No
Secondary	Disability	Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire	3 and 6 months after randomization	No
Secondary	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	No

External Links

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