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

Not Applicable

Completed

• Conditions: Chronic Disease; Low Back Pain
• Interventions: Other: Myofascial Soft Tissue Release; Other: Kinesio taping treatment

• Registration Number: NCT02067494
• Lead Sponsor: Universidad de Almeria

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-20
• Primary Completion: 2014-09
• Study Completion: 2014-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Score ≥ 4 on the Roland Morris Disability Questionnaire.
• Low Back Pain for ≥ 3 months.
• Not undergoing another physical therapy treatment.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myofascial Soft Tissue Release	Myofascial Soft Tissue Release	* 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.
Kinesio taping treatment	Kinesio taping treatment	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Roland Morris Disability Questionnaire (RMDQ)	At baseline, 10 weeks and 15 weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidad de Almeria; 🇪🇸 Almería, Spain