- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04893720
The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic back pain (CBP) is a very common clinical problem. It is dominantly caused by degenerative changes, while specific causes such as tumor, trauma or inflammatory conditions are relatively rare. Back pain may be a concomitant symptom of lumbar disc herniation or spinal canal stenosis and is a typical symptom of spondylolisthesis. Magnetic resonance imaging (MRI) plays a key role in the diagnosis, showing in detail the soft structures, vertebral bodies (Modic changes, MC) or signs of facet arthropathy. On the other hand, it also proves a number of clinically silent findings. Degenerative disc disease (DDD) or facet osteoarthritis are most often considered to be a pain generator. The problem, however, is that both entities are very common in the general population without a painful correlate, and there is still controversy in the literature about their role in the genesis of CBP.
Radionuclide bone scintigraphy with single photon emission computed tomography (SPECT) provides functional imaging and is used to detect microcalcification due to increased osteoblastic activity. In the absence of other pathology the foci of increased osteoblastic activity reflex areas of mechanical stress and degenerative change in the skeleton. There is growing evidence about the relationship between DDD, facet arthropathy, and SPECT positivity. Although these findings have been recently confirmed by surgical studies, the evidence about the effect of surgical treatment of SPECT positive lumbar degeneration is still weak due to the small number of operated patients.
The aim of the present study is to define a possible correlation between degenerative changes of the lumbar spine and positivity on SPECT/CT imaging. Patients with multilevel SPECT+ DDD or facet arthropathy will undergo spinal fusion of the involved segments. Postoperative improvement will be measured by ODI (Oswestry Disability Index) and pain VAS (Visual Analogue Scale) in 6 and 24 months follow-up period.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Radek Kaiser
- Phone Number: +420607545132
- Email: rkaiser@hotmail.cz
Study Contact Backup
- Name: Jaroslav Plas
- Email: jaroslav.plas@uvn.cz
Study Locations
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Prague, Czechia, 16902
- Recruiting
- Military University Hospital Prague
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Contact:
- Radek Kaiser
- Phone Number: +420607545132
- Email: radek.kaiser@uvn.cz
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Principal Investigator:
- Radek Kaiser
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Prague, Czechia
- Recruiting
- University Hospital, Motol
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Contact:
- Michal Varga
- Email: vargamisko12@gmail.com
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Sub-Investigator:
- Michal Varga
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Lower back pain (in extension +/- pain in buttocks, groin, thigh) without radicular pain
- Symptoms > 6 months after the failure of conservative management in the primary care setting
- MRI signs of degenerative disc disease or facet arthropathy
- Two- or more levels of positivity on lumbar SPECT/CT
Exclusion Criteria:
- Other spinal pathology (tumors, congenital defects, spondylolysis, or spondylolisthesis)
- Intolerance of SPECT examination
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Oswestry Disability Index (ODI)
Time Frame: 2 years
|
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire.
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. he scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100).
Zero is equated with no disability and 100 is the maximum disability possible.
|
2 years
|
Change in Pain Visual Analogue Scale (VAS)
Time Frame: 2 years
|
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain.
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between VAS 0 (no pain) and VAS 10 (worst pain).
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jaroslav Plas, jaroslav.plas@uvn.cz
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPINUS-UVN II
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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