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

Not Applicable

Completed

• Conditions: Nonspecific Chronic Low Back Pain

• Registration Number: NCT01866332
• Lead Sponsor: Universidade Cidade de Sao Paulo

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.

Study Timeline

• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-05-31
• Study Start: 2013-06
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-14
• Last Update Posted: 2015-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensity	Five weeks after randomization	Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
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

Name	Time	Method
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
Pain Intensity	3 and 6 months after randomization	Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability	3 and 6 months after randomization	Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire

Trial Locations

Locations (1)

Physical Therapy Outpatient Department; 🇧🇷 São Paulo, SP, Brazil