Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Lumbar Fusion; Lumbar Spinal Fusion Surgery

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10055
    • School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wei-Li Hsu, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 24, 2018
• Study Completion (Actual): February 14, 2020

Study Registration Dates

• First Submitted: October 5, 2012
• First Submitted That Met QC Criteria: October 9, 2012
• First Posted (Estimate): October 10, 2012

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: magnetic resonance imaging (MRI); early rehabilitation; biomechanical changes; assessment model; functional activities; causal relationship; core muscles activation pattern; pathological changes; core stability exercise; minimally invasive lumbar spinal fusion surgery
• Other Study ID Numbers: 201112117RIC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No