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Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

From 20 to 85 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Crossover

Comparing exposures during disease occurrence and non-occurrence in order to assess the short-term effects of triggers.
Observational
Study Start: August 2012
See protocol details

Summary

Principal SponsorNational Taiwan University Hospital
Last updated: September 11, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01703338
Principal SponsorNational Taiwan University Hospital
Last updated: September 11, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Crossover

In this design, participants serve as their own control. Researchers compare a person's exposures just before a health event with exposures at other times, helping identify short-term triggers or risk factors.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
a primary diagnosis of spinal stenosis, spondylosis, degenerative or isthmic spondylolisthesis or degenerative disc disease, and
ages between 20 and 85 years
back pain and/or sciatica exceeding 12 weeks for which conservative treatment had failed to improve
the patient selected for lumbar surgery
4 exclusion criteria prevent from participating
intervertebral angle reversal on dynamic radiographs; and
mechanical back pain due to posture changes and cannot maintain an upright posture over 30 minutes
previous lumbar fusion, rheumatoid arthritis, and ankylosing spondylitis
segmental instability that includes isthmic spondylolisthesis, degenerative spondylolisthesis over 0.4 cm

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Taipei, TaiwanOpen School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University in Google Maps
SuspendedOne Study Center