Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

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. Identifier: NCT01703338
Recruitment Status : Unknown
Verified February 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 10, 2012
Last Update Posted : October 10, 2012
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

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.

Condition or disease
Lumbar Fusion Lumbar Spinal Fusion Surgery

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery
Study Start Date : August 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015


Information from the National Library of Medicine

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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.

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 identifier (NCT number): NCT01703338

Contact: Wei-Li Hsu, PhD +886-2-3366-8127

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

Responsible Party: National Taiwan University Hospital Identifier: NCT01703338     History of Changes
Other Study ID Numbers: 201112117RIC
First Posted: October 10, 2012    Key Record Dates
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