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

Primary Purpose

Low Back Pain, Chronic Disease

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Myofascial Soft Tissue Release

Kinesio taping treatment

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Chronic Pain, Manual Therapy, Randomized Clinical Trial, Bandages

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universidad de Almeria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myofascial Soft Tissue Release

Kinesio taping treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change form baseline in Visual Analogue Scale

A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.

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.

Change from baseline on Neural Network Analysis

Analysis of the projection on the spine and segmental innervation projection.

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.

Full Information

NCT ID

NCT02067494

First Posted

February 18, 2014

Last Updated

March 4, 2015

Sponsor

Universidad de Almeria

1. Study Identification

Unique Protocol Identification Number

NCT02067494

Brief Title

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

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Almeria

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Chronic Disease

Keywords

Low Back Pain, Chronic Pain, Manual Therapy, Randomized Clinical Trial, Bandages

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Myofascial Soft Tissue Release

Arm Type

Experimental

Arm Description

Arm Title

Kinesio taping treatment

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Myofascial Soft Tissue Release

Intervention Description

Intervention Type

Other

Intervention Name(s)

Kinesio taping treatment

Intervention Description

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 Measure Information:

Title

Change from baseline in Roland Morris Disability Questionnaire (RMDQ)

Description

Time Frame

At baseline, 10 weeks and 15 weeks

Secondary Outcome Measure Information:

Title

Change form baseline in Visual Analogue Scale

Description

A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.

Time Frame

At baseline, 10 weeks and 15 weeks

Title

Change from baseline in Lifestyle Indicators

Description

Estimation of interstitial fluid biochemistry and measure the following indicators: body mass, hormonal, autonomic nervous system and oxidative stress.

Time Frame

At baseline, 10 weeks and 15 weeks

Title

Change from baseline on Neural Network Analysis

Description

Analysis of the projection on the spine and segmental innervation projection.

Time Frame

At baseline, 10 weeks and 15 weeks

Title

Change from baseline on Quality of Life

Description

SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.

Time Frame

At baseline, 10 weeks and 15 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adelaida Castro-Sánchez, Lecturer

Organizational Affiliation

Universidad de Almeria

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universidad de Almeria

City

Almería

ZIP/Postal Code

04120

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

24481595

Citation

Nijs J, Meeus M, Cagnie B, Roussel NA, Dolphens M, Van Oosterwijck J, Danneels L. A modern neuroscience approach to chronic spinal pain: combining pain neuroscience education with cognition-targeted motor control training. Phys Ther. 2014 May;94(5):730-8. doi: 10.2522/ptj.20130258. Epub 2014 Jan 30.

Results Reference

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PubMed Identifier

24462537

Citation

Taylor JB, Goode AP, George SZ, Cook CE. Incidence and risk factors for first-time incident low back pain: a systematic review and meta-analysis. Spine J. 2014 Oct 1;14(10):2299-319. doi: 10.1016/j.spinee.2014.01.026. Epub 2014 Jan 23.

Results Reference

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PubMed Identifier

24453669

Citation

Adorno ML, Brasil-Neto JP. Assessment of the quality of life through the SF-36 questionnaire in patients with chronic nonspecific low back pain. Acta Ortop Bras. 2013 Jul;21(4):202-7. doi: 10.1590/S1413-78522013000400004.

Results Reference

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PubMed Identifier

24450372

Citation

Biely SA, Silfies SP, Smith SS, Hicks GE. Clinical observation of standing trunk movements: what do the aberrant movement patterns tell us? J Orthop Sports Phys Ther. 2014 Apr;44(4):262-72. doi: 10.2519/jospt.2014.4988. Epub 2014 Jan 22.

Results Reference

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PubMed Identifier

24421630

Citation

Kramer CD, Koch WH, Fritz JM. Development and outcomes of a program to translate the evidence for spinal manipulation into physical therapy practice. J Man Manip Ther. 2013 Nov;21(4):177-86. doi: 10.1179/2042618613Y.0000000036.

Results Reference

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PubMed Identifier

24396190

Citation

Bae SH, Lee JH, Oh KA, Kim KY. The effects of kinesio taping on potential in chronic low back pain patients anticipatory postural control and cerebral cortex. J Phys Ther Sci. 2013 Nov;25(11):1367-71. doi: 10.1589/jpts.25.1367. Epub 2013 Dec 11.

Results Reference

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PubMed Identifier

24284272

Citation

Alvarez-Alvarez S, Jose FG, Rodriguez-Fernandez AL, Gueita-Rodriguez J, Waller BJ. Effects of Kinesio(R) Tape in low back muscle fatigue: randomized, controlled, doubled-blinded clinical trial on healthy subjects. J Back Musculoskelet Rehabil. 2014;27(2):203-12. doi: 10.3233/BMR-130437.

Results Reference

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PubMed Identifier

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Citation

Added MA, Costa LO, Fukuda TY, de Freitas DG, Salomao EC, Monteiro RL, Costa Lda C. Efficacy of adding the Kinesio Taping method to guideline-endorsed conventional physiotherapy in patients with chronic nonspecific low back pain: a randomised controlled trial. BMC Musculoskelet Disord. 2013 Oct 24;14:301. doi: 10.1186/1471-2474-14-301.

Results Reference

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PubMed Identifier

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Citation

Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. J Physiother. 2012;58(2):89-95. doi: 10.1016/S1836-9553(12)70088-7. Erratum In: J Physiother. 2012;58(3):143.

Results Reference

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PubMed Identifier

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Citation

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Results Reference

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

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