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Clinical Trials/NCT01703338
NCT01703338
Terminated
Not Applicable

Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

National Taiwan University Hospital1 site in 1 country100 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Fusion
Sponsor
National Taiwan University Hospital
Enrollment
100
Locations
1
Status
Terminated
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
February 14, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ages between 20 and 85 years,
  • back pain and/or sciatica exceeding 12 weeks for which conservative treatment had failed to improve,
  • a primary diagnosis of spinal stenosis, spondylosis, degenerative or isthmic spondylolisthesis or degenerative disc disease, and
  • the patient selected for lumbar surgery

Exclusion Criteria

  • mechanical back pain due to posture changes and cannot maintain an upright posture over 30 minutes;
  • segmental instability that includes isthmic spondylolisthesis, degenerative spondylolisthesis over 0.4 cm;
  • intervertebral angle reversal on dynamic radiographs; and
  • previous lumbar fusion, rheumatoid arthritis, and ankylosing spondylitis.

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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