- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02459366
Correlation of Thoracolumbar Fascia Mechanical Properties and Compensate Mechanisms of Asymmetric Skeletal Muscle
Study of School and Graduate Institute of Physical Therapy College of Medicine in Taiwan
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Test2
-
Taipei, Test2, Taiwan, test3
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Shwu-Fen Wang
- Phone Number: 886-33668139
- Email: sfwang@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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:
- Can not communicate clearly with people
- Any open wounds
- Any history of cancer or malignancy
- The bleeding disorders
- Pregnancy
Study Plan
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
Investigators
- Principal Investigator: Shwu-Fen Wang, NTUH
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Low Back Pain
-
University of Kansas Medical CenterCompletedLower Back Pain | Low Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, Postural | Postural Low Back Pain | Mechanical Low Back Pain | Low Back Ache | Recurrent Low Back Pain | Lower Back Pain Chronic | Low Back Pain, Posterior Compartment | Low BackacheUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
Istanbul UniversityIstinye UniversityCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, PosturalTurkey
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
General Incorporated Foundation Ryukyuseimeisaiseikai...CompletedChronic Low Back Pain | Non-specific Low Back Pain | Low Back Pain (LBP)Japan
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
MMJ Labs LLCNational Institute on Drug Abuse (NIDA); Sport and Spine Rehab Clinical Research...CompletedChronic Low-back Pain | Pain, Intractable | Acute Low-back PainUnited States
-
Pamukkale UniversityCompletedLow Back Disorder | Low Back Pain (LBP)Turkey