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Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01703338
First received: October 5, 2012
Last updated: October 9, 2012
Last verified: February 2012
  Purpose

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
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)

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
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.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703338

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

Locations
Taiwan
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
Investigators
Principal Investigator: Wei-Li Hsu, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01703338     History of Changes
Other Study ID Numbers: 201112117RIC
Study First Received: October 5, 2012
Last Updated: October 9, 2012
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on November 25, 2014