Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

NCT01703338 | Terminated DMC

• 1 other identifier: 201112117RIC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Fusion; Lumbar Spinal Fusion Surgery

Keywords

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

Study Arms (1)

Lumbar spinal surgery

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

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

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

Taipei, 10055, Taiwan

Location

Study Officials

• Wei-Li Hsu, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: August 1, 2012
• Primary Completion: December 24, 2018
• Study Completion: February 14, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

TW (1)