NCT01703338|TerminatedDMC
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Sponsor study identifier
observational
100
1 country
1
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 24, 2018
Actual (reported)Study Completion
February 14, 2020
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 14, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 5, 2012
Actual (reported)October 10, 2012
Actual (reported)December 24, 2018
Actual (reported)February 14, 2020
Actual (reported)The study included participants who were diagnosed by a neurological surgeon and received lumbar surgery according to relevant imaging findings
All subjects will be recruited from the National Taiwan University Hospital and 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 neurological surgeon will response for subject screening and medical diagnose. According to the power analysis, fifty subjects will be enrolled in this study. The eligible subject will be given the subjects informed consent and sign it before the enrollment.
School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei, 10055, Taiwan
Wei-Li Hsu, PhD
National Taiwan University Hospital
100 participants (actual enrollment reported by the registry).
First Submitted
October 5, 2012
First Posted
October 10, 2012
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Lumbar Fusion With Nanotube Versus Titanium Cage
Contact the study team to confirm eligibility.
Primary Completion
December 24, 2018
Actual (reported)Study Completion
February 14, 2020
Actual (reported)Last Updated
September 11, 2020
Record last verified: 2020-09
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Source: ClinicalTrials.gov.
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