NCT02067494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

February 18, 2014

Last Update Submit

March 4, 2015

Conditions

Keywords

Low Back PainChronic PainManual TherapyRandomized Clinical TrialBandages

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change form baseline in Visual Analogue Scale

    At baseline, 10 weeks and 15 weeks

  • Change from baseline in Lifestyle Indicators

    At baseline, 10 weeks and 15 weeks

  • Change from baseline on Neural Network Analysis

    At baseline, 10 weeks and 15 weeks

  • Change from baseline on Quality of Life

    At baseline, 10 weeks and 15 weeks

Study Arms (2)

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.

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.

Other: Kinesio taping treatment

Interventions

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 Soft Tissue Release

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.

Kinesio taping treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Almeria

Almería, Almería, 04120, Spain

Location

Related Publications (10)

  • 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.

    PMID: 24481595BACKGROUND
  • 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.

    PMID: 24462537BACKGROUND
  • 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.

    PMID: 24453669BACKGROUND
  • 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.

    PMID: 24450372BACKGROUND
  • 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.

    PMID: 24421630BACKGROUND
  • 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.

    PMID: 24396190BACKGROUND
  • 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.

    PMID: 24284272BACKGROUND
  • 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.

    PMID: 24156687BACKGROUND
  • 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.

    PMID: 22613238BACKGROUND
  • 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.

    PMID: 23068906BACKGROUND

MeSH Terms

Conditions

Low Back PainChronic DiseaseChronic Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Adelaida Castro-Sánchez, Lecturer

    Universidad de Almeria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 20, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

November 1, 2014

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations