Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01703338
Recruitment Status : Terminated
First Posted : October 10, 2012
Last Update Posted : September 11, 2020
Sponsor:
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

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 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
Actual Primary Completion Date : December 24, 2018
Actual Study Completion Date : February 14, 2020

Group/Cohort
Lumbar spinal surgery
The study included participants who were diagnosed by a neurological surgeon and received lumbar surgery according to relevant imaging findings




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.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. ages between 20 and 85 years,
  2. back pain and/or sciatica exceeding 12 weeks 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. the patient selected for lumbar surgery

Exclusion Criteria:

  1. mechanical back pain due to posture changes and cannot maintain an 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 ClinicalTrials.gov identifier (NCT number): NCT01703338


Locations
Layout table for location information
Taiwan
School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei, Taiwan, 10055
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Wei-Li Hsu, PhD National Taiwan University Hospital
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01703338    
Other Study ID Numbers: 201112117RIC
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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