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

Low Back Pain Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067494
• Other study ID #: UAL-032
• Status: Completed
• Phase: N/A
• First received: February 18, 2014
• Last updated: March 4, 2015
• Start date: February 2014
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Disease
• Low Back Pain

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Universidad de Almeria	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (10)

Added MA, Costa LO, Fukuda TY, de Freitas DG, Salomão 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. — View 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. — View Citation

Álvarez-Álvarez S, José FG, Rodríguez-Fernández AL, Güeita-Rodríguez J, Waller BJ. Effects of Kinesio® 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. — View 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. — View 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. — View Citation

Castro-Sánchez AM, Lara-Palomo IC, Matarán-Peñarrocha GA, Fernández-Sánchez M, Sánchez-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. — View 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. — View Citation

Lee JH, Yoo WG. Application of posterior pelvic tilt taping for the treatment of chronic low back pain with sacroiliac joint dysfunction and increased sacral horizontal angle. Phys Ther Sport. 2012 Nov;13(4):279-85. doi: 10.1016/j.ptsp.2011.10.003. Epub 2011 Dec 8. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No