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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Nonspecific Chronic Low Back Pain

Intervention / Treatment
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* Other: Conventional Physical Therapy
* Device: Kinesio Tex Gold ( Kinesiotaping )


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Physical Therapy<br>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<br>* 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).<br>* Other names: Specific exercises;|
| Experimental: Conventional Physical Therapy plus Kinesiotaping<br>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<br>* 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).<br>* Other names: Specific exercises;Device: Kinesio Tex Gold ( Kinesiotaping )<br>* 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).<br>* Other names: Kinesiotape;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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back pain, tape, chronic