We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: October 10, 2012
Last Update Posted: October 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital

Lumbar fusion has been widely used for spinal disorders when conservative treatment has failed. However, a number of studies have reported that the rate of re-operation is high for lumbar fusion surgery. Swelling, atrophy or fat infiltration of the paraspinal muscles at the surgery site can cause weakness and pain. After fusion, the range of motion is constrained at the fused spine and might facilitate compensative movement of the adjacent levels and increase degeneration rate of the spine.

Evidence has shown that core muscles play an important role to stabilize and support the spine. Whether core stability exercise can enhance spinal stability after lumbar fusion surgery remains unclear. Therefore, the overall goal of this proposed research is to investigate how core muscles affect outcomes after lumbar spinal fusion. The investigators will explore this issue hierarchically and systematically in 3-year duration.

Lumbar Fusion Lumbar Spinal Fusion Surgery

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All subjects will be recruited from Far Eastern Memorial Hospital. The study is approved by the Institutional Medical Research Ethics Committees in both National Taiwan University Hospital and Far Eastern Memorial Hospital. Our orthopedic surgeons will response for subject screening and medical diagnose. According to the power analysis, fifty subjects will be enrolled in this study. Eligible subject will be given the subjects informed consent and sign it before the enrollment.

Inclusion Criteria:

  1. ages between 45 and 85 years,
  2. back pain and/or sciatica exceeding 12 months for which conservative treatment had failed to improve,
  3. a primary diagnosis of spinal stenosis, spondylosis, degenerative or isthmic spondylolisthesis or degenerative disc disease, and
  4. patient selected for lumbar fusion with or without decompression.

Exclusion Criteria:

  1. mechanical back pain due to posture changes and cannot maintain a upright posture over 30 minutes;
  2. segmental instability that includes isthmic spondylolisthesis, degenerative spondylolisthesis over 0.4 cm;
  3. intervertebral angle reversal on dynamic radiographs; and
  4. previous lumbar fusion, rheumatoid arthritis, and ankylosing spondylitis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703338

Contact: Wei-Li Hsu, PhD +886-2-3366-8127 wlhsu@ntu.edu.tw

School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University Recruiting
Taipei, Taiwan, 10055
Contact: Wei-Li Hsu, PhD    +886-2-33668127    wlhsu@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Wei-Li Hsu, PhD National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01703338     History of Changes
Other Study ID Numbers: 201112117RIC
First Submitted: October 5, 2012
First Posted: October 10, 2012
Last Update Posted: October 10, 2012
Last Verified: February 2012

Keywords provided by National Taiwan University Hospital:
assessment model
biomechanical changes
functional activities
magnetic resonance imaging (MRI)
causal relationship
core muscles activation pattern
pathological changes
early rehabilitation
core stability exercise
minimally invasive lumbar spinal fusion surgery