Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

Lumbar Fusion Clinical Trial

Official title:

Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01703338
• Other study ID #: 201112117RIC
• Status: Terminated
• Start date: August 2012
• Est. completion date: February 14, 2020

Study information

• Verified date: September 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: February 14, 2020
• Est. primary completion date: December 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Fusion
• Lumbar Spinal Fusion Surgery

Locations

Country	Name	City	State
Taiwan	School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,