Clinical Outcome After Lumbar Fusion

Chronic Low Back Pain Clinical Trial

Official title:

Clinical Outcome After Lumbar Fusion for the Treatment of Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155789
• Other study ID #: LSU-7270
• Status: Completed
• Phase: N/A
• First received: May 12, 2017
• Last updated: May 15, 2017
• Start date: July 2010
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this prospective study is to compare the clinical outcomes after lumbar fusion for chronic low back pain using the four techniques commonly employed in our surgical practice. Lumbar fusion stops motion at a painful vertebral segment, which can decrease back pain. The four techniques are standard transforaminal lumbar interbody fusion (S TLIF), minimally invasive transforaminal lumbar interbody fusion (MI TLIF), extreme lateral interbody fusion (XLIF), and axial lumbar interbody fusion (AxiaLIF). Each differ in where incisions are made and level of invasiveness; not all may be implemented in each surgical case. The four different techniques are all standard approaches with different advantages and have yet to be compared in efficacy for relieving chronic low back pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Severe chronic low back pain (at least 7 out of 10 on the VAS scale).

• Age: 25-65 years.

• Pain duration at least 2 years.

• The treating surgeon should interpret the pain as emanating from L4-S1.

• The patient must have had unsuccessful maximal possible conservative (non surgical) treatment for at least one year.

• Radiographic evidence (MRI, CT, CT-SPECT, and/or plain films) of degenerative changes ("spondylosis")

Exclusion Criteria:

• Psychiatric illness or evidence of emotional instability.

• Previous spine surgery except for successful removal of a herniated disc more than 2 years before entering the study and with no persistent nerve root symptoms.

• Specific radiologic findings, such as fractures, infection, inflammatory process, or neoplasm.

• Obvious painful and disabling arthritic hip joints and anamnestic and radiologic signs of spinal stenosis.

• Involvement in Workman's Comp or litigation.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Procedure:
• Lumbar Fusion
Standard Transforaminal Lumbar Interbody Fusion (S TLIF) Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF) AxiaLIF Fusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Visual Analog Scale (VAS)	This is part of the Patient Questionnaire primary outcome measure. A Visual Analogue Scale (VAS) is a measurement instrument that measures the intensity or frequency of pain across a continuum of values.	2 weeks, 6 months, 1 year
Primary	Change from Baseline Prolo Functional and Economic Score	This is part of the Patient Questionnaire primary outcome measure. The Prolo Score is a 10-point scale consisting of only two questions evaluating the functional and economic status of the patient.	2 weeks, 6 months, 1 year
Primary	Change from Baseline Dallas Pain Questionnaire (DPQ)	This is part of the Patient Questionnaire primary outcome measure. The Dallas Pain Questionnaire (DPQ) assess the amount of chronic spine pain that affects the patient's daily and work-leisure activities, anxiety-depression, and social interest.	2 weeks, 6 months, 1 year
Primary	Change from Baseline Short Form 12 (SF-12)	This is part of the Patient Questionnaire primary outcome measure. The Short Form 12 (SF-12) was designed to measure the patient's functional health and well-being.	2 weeks, 6 months, 1 year
Primary	Change from Baseline Oswestry Disability Index (ODI)	This is part of the Patient Questionnaire primary outcome measure. The Oswestry Disability Index measures a patient's impairment and quality of life due to pain.	2 weeks, 6 months, 1 year
Secondary	Radiologic Fusion Rates	Fusion rates will be evaluated by flexion-extension X-rays and CT imaging.	6 months and 1 year