Myofascial Release and Kinesio Taping on Autonomic Nervous System in Low Back Pain

Study Overview
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Brief Summary
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The purpose of this current randomized clinical trial is to determine the effects of myofascial soft tissue release and kinesio taping on disability, pain, quality of life, autonomic nervous system and oxidative stress indicators in chronic low back pain.

Detailed Description
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Design: Randomized Clinical Trial. Objective: to determine the effects of myofascial soft tissue release and kinesio taping on pain, disability, quality of life, and autonomic nervous system indicators. Methods and Measures: sixty-four individuals will be randomly assigned to one of two groups. Intervention: For 10-week, the group 1 will undergo treatment comprising a myofascial soft tissue release protocol (1/week) and the group 2 will recieve a kinesio taping treatment (1/week). Main Outcome Measures: Intensity of pain, disability, quality of life, biochemical stimation intertitial fluid, body mass indicators, hormonal indicators, indicators of autonomic nevous system, and indicators of oxidative stress will be collected in both groups at baseline, 10 weeks and 15 weeks after the last intervention. Baseline demographic and clinical variables will be examined between both groups with an independent Student t-test for continuous data. Separate 2x3 model ANOVA with time (baseline, 10 weeks and 15 weeks) as the within-subjects factor, group will be to determine the effects of the treatment.

Official Title
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Myofascial Release and Kinesiotaping on Disability, Pain, Automic Nervous System and Oxidative Stress Indicators in Chronic Low Back Pain: A Randomized Controlled Clinical Trial

Conditions
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Low Back Pain, Chronic Disease

Intervention / Treatment
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* Other: Myofascial Soft Tissue Release
* Other: Kinesio taping treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Score ≥ 4 on the Roland Morris Disability Questionnaire. Low Back Pain for ≥ 3 months. Not undergoing another physical therapy treatment. Exclusion Criteria: Disease of the central or peripheral nervous system. Having previously undergone manual therapy. Contraindication to low back manual therapy. A history of spinal surgery. Treatment with corticosteroid in the past two weeks. Clinical sign of radiculopathy Presence of Stenosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myofascial Soft Tissue Release<br>Protocol: Myofascial release on thoracolumbar fascia, Myofascial release on diaphragm, Myofascial release in the psoas fascia, Indirect Myofascial release restrictions in the public area, Myofascial release in lumbo-sacral decompression, Myofascial release on sacrum, and Myofascial release on the lumbar fascia. Myofascial release assisted the paravertebral fascia. | Other: Myofascial Soft Tissue Release<br>* Protocol: Myofascial release on thoracolumbar fascia, Myofascial release on diaphragm, Myofascial release in the psoas fascia, Indirect Myofascial release restrictions in the public area, Myofascial release in lumbo-sacral decompression, Myofascial release on sacrum, and Myofascial release on the lumbar fascia.<br>|
| Active Comparator: Kinesio taping treatment<br>Two bands in I, with anchor onset in sacrum, on paravertebral muscles. Furthermore a strip will be applies on correction space point of maximum pain. | Other: Kinesio taping treatment<br>* Two bands in I, with anchor onset in sacrum, on paravertebral muscles. Furthermore a strip will be applies on correction space point of maximum pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Roland Morris Disability Questionnaire (RMDQ) | This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities | At baseline, 10 weeks and 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change form baseline in Visual Analogue Scale | A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain. | At baseline, 10 weeks and 15 weeks | 
| Change from baseline in Lifestyle Indicators | Estimation of interstitial fluid biochemistry and measure the following indicators: body mass, hormonal, autonomic nervous system and oxidative stress. | At baseline, 10 weeks and 15 weeks | 
| Change from baseline on Neural Network Analysis | Analysis of the projection on the spine and segmental innervation projection. | At baseline, 10 weeks and 15 weeks | 
| Change from baseline on Quality of Life | SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life. | At baseline, 10 weeks and 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain, Chronic Pain, Manual Therapy, Randomized Clinical Trial, Bandages