Chronic Low Back PainNCT03155789
Clinical Outcome After Lumbar Fusion
An observational study of Chronic Low Back Pain, run by Louisiana State University Health Sciences Center in New Orleans.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Lumbar Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Adult, Older adult
Study population: Each patient who is willing to participate in this study, signs informed consent, and complies with the inclusion/exclusion criteria will be enrolled in the study. Each patient will be enrolled chronologically on a patient enrollment log and given a patient number for the duration of the study.
Who may be able to join
- 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")
Who cannot join
- 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.
About this study
Official title: Clinical Outcome After Lumbar Fusion for the Treatment of Chronic Low Back Pain
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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Lumbar Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar FusionProcedure or surgery
Standard Transforaminal Lumbar Interbody Fusion (S TLIF)
Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF)
AxiaLIF Fusion
| Study group | Role | What they receive |
|---|---|---|
| Low Back Pain emanating from L4-5 | 1. S TLIF at L4-5 (n=10)
2. MI TLIF at L4-5 (n=10)
3. XLIF at L4-5 (n=10) Receives: Procedure: Lumbar Fusion | |
| Low Back Pain emanating from L5-S1 | 1. S TLIF at L5-S1 (n=10)
2. MI TLIF at L5-S1 (n=10)
3. XLIF at L5-S1 (n=10) Receives: Procedure: Lumbar Fusion | |
| Low Back Pain emanating from L4-5 and L5-S1 | 1. S TLIF at L4-5 and L5-S1 (n=10)
2. MI TLIF at L4-5 and L5-S1 (n=10)
3. XLIF at L4-5 and L5-S1 (n=10) Receives: Procedure: Lumbar Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks, 6 months, 1 year
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.
Measured: 2 weeks, 6 months, 1 year
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.
Measured: 2 weeks, 6 months, 1 year
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.
Measured: 2 weeks, 6 months, 1 year
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.
Measured: 2 weeks, 6 months, 1 year
Secondary outcomes (1)
Radiologic Fusion Rates
Fusion rates will be evaluated by flexion-extension X-rays and CT imaging.
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startJul 2010
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel C. Tender, MD, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155789
- Sponsor's protocol ID
- LSU-7270
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serban D, Calina N, Tender G. Standard versus Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Prospective Randomized Study. Biomed Res Int. 2017;2017:7236970. doi: 10.1155/2017/7236970. Epub 2017 Jun 15.
PubMed 28698876
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome After Lumbar Fusion for the Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03155789
- Acronym / sponsor ID
- LSU-7270
- Conditions
- Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain emanating from L4-5 | – | Procedure: Lumbar Fusion1. S TLIF at L4-5 (n=10) 2. MI TLIF at L4-5 (n=10) 3. XLIF at L4-5 (n=10) |
| Low Back Pain emanating from L5-S1 | – | Procedure: Lumbar Fusion1. S TLIF at L5-S1 (n=10) 2. MI TLIF at L5-S1 (n=10) 3. XLIF at L5-S1 (n=10) |
| Low Back Pain emanating from L4-5 and L5-S1 | – | Procedure: Lumbar Fusion1. S TLIF at L4-5 and L5-S1 (n=10) 2. MI TLIF at L4-5 and L5-S1 (n=10) 3. XLIF at L4-5 and L5-S1 (n=10) |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Each patient who is willing to participate in this study, signs informed consent, and complies with the inclusion/exclusion criteria will be enrolled in the study. Each patient will be enrolled chronologically on a patient enrollment log and given a patient number for the duration of the study.
Key inclusion criteria (6 listed)
- Severe chronic low back pain (at least 7 out of 10 on the VAS scale).
Key exclusion criteria (5 listed)
- Psychiatric illness or evidence of emotional instability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar FusionStandard Transforaminal Lumbar Interbody Fusion (S TLIF) Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF) AxiaLIF Fusion | Procedure or surgery | Low Back Pain emanating from L4-5, Low Back Pain emanating from L4-5 and L5-S1, Low Back Pain emanating from L5-S1 |
Primary outcome
Change from Baseline Visual Analog Scale (VAS)
Time frame: 2 weeks, 6 months, 1 year
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.
Change from Baseline Prolo Functional and Economic Score
Time frame: 2 weeks, 6 months, 1 year
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.
Change from Baseline Dallas Pain Questionnaire (DPQ)
Time frame: 2 weeks, 6 months, 1 year
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.
Change from Baseline Short Form 12 (SF-12)
Time frame: 2 weeks, 6 months, 1 year
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.
Change from Baseline Oswestry Disability Index (ODI)
Time frame: 2 weeks, 6 months, 1 year
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.
1 secondary outcome
Radiologic Fusion Rates
Time frame: 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Derived from this study: PubMed 28698876Serban D, Calina N, Tender G. Standard versus Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Prospective Randomized Study. Biomed Res Int. 2017;2017:7236970. doi: 10.1155/2017/7236970. Epub 2017 Jun 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain, run by Louisiana State University Health Sciences Center in New Orleans.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Visual Analog Scale (VAS) (time frame: 2 weeks, 6 months, 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03155789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.