Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

NCT ID: NCT01703338

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2020-02-14

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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Lumbar spinal surgery

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

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei-Li Hsu, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201112117RIC

Identifier Type: -

Identifier Source: org_study_id