Correlation of Thoracolumbar Fascia Mechanical Properties and Compensate Mechanisms of Asymmetric Skeletal Muscle

December 29, 2015 updated by: National Taiwan University Hospital

Study of School and Graduate Institute of Physical Therapy College of Medicine in Taiwan

The objective of three-year research is to investigate the relationship between thoracolumbar fascia tissue characteristics, lumbopelvic asymmetry, core muscle contractility, proprioception and standing balance in different ages of asymptomatic participants and patients with CMLBP.

Study Overview

Status

Unknown

Conditions

Detailed Description

Background: Chronic myofascial low back pain (CMLBP) is a common musculoskeletal disease. Deep fascia is the structures which insufficient in the theory of spinal stability, the major biomechanical role of the thoracolumbar fascia are segmental control and stability of the spine and sacroiliac joint, its biomechanical role is influenced by its mechanical properties of the fascia. Fascia provide the function of sensation and coordination, it is helpful for discussion the compensatory mechanisms for patients with chronic low back pain, and contribution to the development of appropriate therapeutic strategies or combined treatments in innovative applications. However due to the lack of understanding of myofascia, there are difficulties in diagnosis and treatments. It is necessary to establish methods of assessing fascia and complete series of study for understanding fascia and its attaching muscles.

Objective: The objective of three-year research is to investigate the relationship between thoracolumbar fascia tissue characteristics, lumbopelvic asymmetry, core muscle contractility, proprioception and standing balance in different ages of asymptomatic participants and patients with CMLBP.

Method: 270 subjects are recruited in this study, with ages ranging from 20 to 74 years old. 120 of the subjects are patients with CMLBP and 150 are asymptomatic participants. Instrument in use including real time ultrasound imaging, Zebris 3D motionanalysis system and force plate system. The first year is to establish the reliability of measurement of lumbopelvic asymmetry, mechanical and physical properties of thoracolumbar fascia, and the norm of different age. The second year is to compare the differences among asymptomatic subjects and patients with and without lumbopelvic asymmetry, and investigate whether lumbopelvic symmetry, core muscle contractility, proprioception and standing balance change after manipulating thoracolumbar fascia tissue by physical therapy. The third year is to investigate the treatment effect on chronic myofascial back pain patient after 8 weeks exercise training with the aid of physical agent.

Study Type

Observational

Enrollment (Anticipated)

270

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

    • Test2
      • Taipei, Test2, Taiwan, test3
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

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

16 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

Inclusion criteria:

  • Asymptomatic subjects
  • Age between 20-74 years old
  • In the past three months did not feel uncomfortable more than one day on waist region, and did not relapsed more than once within three months

Subjects with chronic low back pain

  • Age between 20-74 years old
  • In the past three months felt uncomfortable more than one day on waist region, and relapsed more than once within three months
  • Visual pain scores (VAS ≧ 3)

Exclusion criteria:

  1. Can not communicate clearly with people
  2. Any open wounds
  3. Any history of cancer or malignancy
  4. The bleeding disorders
  5. Pregnancy

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
control
establish the reliability of measurement of lumbopelvic asymmetry, mechanical and physical properties of thoracolumbar fascia, and the norm of different age
low back pain
compare the differences among asymptomatic subjects and patients with and without lumbopelvic asymmetry, and investigate whether lumbopelvic symmetry, core muscle contractility, proprioception and standing balance change after manipulating thoracolumbar fascia tissue by physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tissue characteristics of thoracolumbar
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contraction ability of core muscles
Time Frame: 30 minutes
using ultrasound image to measure the thickness change of core muscles
30 minutes
The re-position range of motion of lumbar spine
Time Frame: 30 minutes
30 minutes
Scale of standing balance
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Shwu-Fen Wang, NTUH

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

May 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

May 28, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201412156RINA

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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