Low Back PainNCT02459366
Correlation of Thoracolumbar Fascia Mechanical Properties and Compensate Mechanisms of Asymmetric Skeletal Muscle
An observational study of Low Back Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 270 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2015to Jul 2018
- Phase
- Observational
- 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 20 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- 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)
Who cannot join
- Can not communicate clearly with people
- Any open wounds
- Any history of cancer or malignancy
- The bleeding disorders
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Wei-Ju Lin contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Test2, test3
Shwu-Fen Wang, 886-33668139, sfwang@ntu.edu.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Keywords
- Thoracolumbar fascia, Mechanical properties, Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Tissue characteristics of thoracolumbar
Measured: 30 minutes
Secondary outcomes (3)
Contraction ability of core muscles
using ultrasound image to measure the thickness change of core muscles
Measured: 30 minutes
The re-position range of motion of lumbar spine
Measured: 30 minutes
Scale of standing balance
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shwu-Fen Wang, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459366
- Sponsor's protocol ID
- 201412156RINA
- Status last verified
- Dec 2015
- First submitted
- 26 May 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of School and Graduate Institute of Physical Therapy College of Medicine in Taiwan
- ClinicalTrials.gov ID
- NCT02459366
- Acronym / sponsor ID
- 201412156RINA
- Conditions
- Low Back Pain
- Keywords
- Thoracolumbar fascia, Mechanical properties, Low back pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 2 Jun 2015 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Can not communicate clearly with people
- Any open wounds
- Any history of cancer or malignancy
- The bleeding disorders
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tissue characteristics of thoracolumbar
Time frame: 30 minutes
3 secondary outcomes
Contraction ability of core muscles
Time frame: 30 minutes
The re-position range of motion of lumbar spine
Time frame: 30 minutes
Scale of standing balance
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
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
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Wei-Ju Lin contact
Shwu-Fen Wang principal investigator
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Dec 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shwu-Fen Wang (886-33668139, sfwang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue characteristics of thoracolumbar (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2015.