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

March 4, 2015 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04120
        • Universidad de Almeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline, 10 weeks and 15 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change form baseline in Visual Analogue Scale
Time Frame: At baseline, 10 weeks and 15 weeks
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
At baseline, 10 weeks and 15 weeks
Change from baseline in Lifestyle Indicators
Time Frame: 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.
At baseline, 10 weeks and 15 weeks
Change from baseline on Neural Network Analysis
Time Frame: At baseline, 10 weeks and 15 weeks
Analysis of the projection on the spine and segmental innervation projection.
At baseline, 10 weeks and 15 weeks
Change from baseline on Quality of Life
Time Frame: 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.
At baseline, 10 weeks and 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAL-032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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