Low Back PainINCT02067494

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

A study testing Myofascial Soft Tissue Release and Kinesio taping treatment in people with Low Back Pain and Chronic Disease, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Low Back Pain, Chronic Disease
What is being tested?: Myofascial Soft Tissue Release and Kinesio taping treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteSpain
Study dates: Feb 2014to Nov 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad de Almeria
Almería, Almería, 04120

Other trials in Spain

About this study

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

Read the 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.

Conditions: Low Back Pain, Chronic Disease
Being tested: Myofascial Soft Tissue Release, Kinesio taping treatment
Keywords: Low Back Pain, Chronic Pain, Manual Therapy, Randomized Clinical Trial, Bandages
Medical subject headings: Low Back Pain, Chronic Disease, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Myofascial Soft Tissue ReleaseOther
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 treatmentOther
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.

Study groups in NCT02067494
Study group	Role	What they receive
Myofascial Soft Tissue Release	Experimental	* 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. Receives: Other: Myofascial Soft Tissue Release
Kinesio taping treatment	Active comparator	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. Receives: Other: Kinesio taping treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: At baseline, 10 weeks and 15 weeks

Secondary outcomes (4)

Change form baseline in Visual Analogue Scale
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, 10 weeks and 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Nov 2014

First posted20 Feb 2014 (estimated)
Study startFeb 2014
Primary completionSep 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02067494
Sponsor's protocol ID: UAL-032
Acronym: I
Status last verified: Mar 2015
First submitted: 18 Feb 2014
Last updated: 5 Mar 2015
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 24481595
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.
PubMed 24462537
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.
PubMed 24453669
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.
PubMed 24450372
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.
PubMed 24421630
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.
PubMed 24396190
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.
PubMed 24284272
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.
PubMed 24156687
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.
PubMed 22613238
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.
PubMed 23068906

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02067494
Acronym / sponsor ID: I / UAL-032
Conditions: Low Back Pain, Chronic Disease
Keywords: Low Back Pain, Chronic Pain, Manual Therapy, Randomized Clinical Trial, Bandages
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Universidad de AlmeriaUniversity, hospital or other
Study start: Feb 2014
Primary completion: Sep 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 20 Feb 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Myofascial Soft Tissue Release	Experimental	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. * Myofascial release assisted the paravertebral fascia.
Kinesio taping treatment	Active comparator	Other: Kinesio taping treatmentTwo bands in "I", with anchor onset in sacrum, on paravertebral muscles. Furthermore a strip will be applies on correction space point of maximum pain.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Myofascial Soft Tissue ReleaseProtocol: 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.	Other	Myofascial Soft Tissue Release
Kinesio taping treatmentTwo 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

Primary outcome

Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
Time frame: 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

4 secondary outcomes

Change form baseline in Visual Analogue Scale
Time frame: At baseline, 10 weeks and 15 weeks
Change from baseline in Lifestyle Indicators
Time frame: At baseline, 10 weeks and 15 weeks
Change from baseline on Neural Network Analysis
Time frame: At baseline, 10 weeks and 15 weeks
Change from baseline on Quality of Life
Time frame: At baseline, 10 weeks and 15 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
Background: PubMed 24481595Nijs 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.
Background: PubMed 24462537Taylor 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.
Background: PubMed 24453669Adorno 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.
Background: PubMed 24450372Biely 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.
Background: PubMed 24421630Kramer 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.
Background: PubMed 24396190Bae 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.
Background: PubMed 24284272Alvarez-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.
Background: PubMed 24156687Added 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.
Background: PubMed 22613238Castro-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.
Background: PubMed 23068906Lee 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.

Related trials for Low Back Pain

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adelaida Castro-Sánchez, Lecturer principal investigator

Universidad de Almeria

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Myofascial Soft Tissue Release and Kinesio taping treatment in people with Low Back Pain and Chronic Disease, run by Universidad de Almeria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Roland Morris Disability Questionnaire (RMDQ) (time frame: At baseline, 10 weeks and 15 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02067494, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.