Degenerative Disc DiseaseNCT04893720
The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
An observational study of Degenerative Disc Disease and Back Pain Lower Back Chronic, run by Military University Hospital, Prague at 2 sites in Czechia.
Trial summary
The aim of the present study is to find out whether fusion of multilevel SPECT/CT positive lumbar degeneration leads to a significant improvement of pain and disability. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Disc Disease, Back Pain Lower Back Chronic, Facet Joint Arthropathy
- What is being tested?
- Lumbar fusion
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Jun 2021to 1 Jun 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: An open prospective cohort study will be performed. Inclusion criteria will be: subjects between 18 and 75 years of age; both genders; with CBP and diagnosis of DDD or facet arthropathy on MRI and increased metabolic activity on bone SPECT/CT imaging in the same levels who are undergoing open lumbar interbody fusion. New MRI of the lumbar spine and SPECT/CT will be performed 2 years after the surgical procedure. The patients will complete ODI and VAS questionnaires before surgery and at 6- and 24-months follow-up visits. All patients will sign an informed consent form.
Who may be able to join
- 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
Who cannot join
- Other spinal pathology (tumors, congenital defects, spondylolysis, or spondylolisthesis)
- Intolerance of SPECT examination
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Jaroslav Plas contact
Czechia2 sites, 2 recruiting
- Recruiting
Military University Hospital Prague
Prague, 16902
Radek Kaiser, +420607545132, radek.kaiser@uvn.cz
Radek Kaiser
- Recruiting
University Hospital, Motol
Prague
Michal Varga, vargamisko12@gmail.com
Michal Varga
About this study
The aim of the present study is to find out whether fusion of multilevel SPECT/CT positive lumbar degeneration leads to a significant improvement of pain and disability.
Read the 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.
- Conditions
- Degenerative Disc Disease, Back Pain Lower Back Chronic, Facet Joint Arthropathy, Facet Syndrome of Lumbar Spine
- Being tested
- Lumbar fusion
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar fusionProcedure or surgery
Transforaminal Lumbar Interbody Fusion of the SPECT/CT positive lumbar degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oswestry Disability Index (ODI)
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.
Measured: 2 years
Change in Pain Visual Analogue Scale (VAS)
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military University Hospital, Prague
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Motol
- Responsible party
- Principal investigator, Radek Kaiser, Military University Hospital, Prague
- Investigators
- Jaroslav Plas, Study chair, jaroslav.plas@uvn.cz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893720
- Sponsor's protocol ID
- SPINUS-UVN II
- Status last verified
- Mar 2024
- First submitted
- 15 May 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
- ClinicalTrials.gov ID
- NCT04893720
- Acronym / sponsor ID
- SPINUS-UVN II
- Conditions
- Degenerative Disc Disease, Back Pain Lower Back Chronic, Facet Joint Arthropathy, Facet Syndrome of Lumbar Spine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Military University Hospital, PragueUniversity, hospital or other
- Collaborators
- University Hospital, Motol
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 19 May 2021 (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 aim of the present study is to find out whether fusion of multilevel SPECT/CT positive lumbar degeneration leads to a significant improvement of pain and disability.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An open prospective cohort study will be performed. Inclusion criteria will be: subjects between 18 and 75 years of age; both genders; with CBP and diagnosis of DDD or facet arthropathy on MRI and increased metabolic activity on bone SPECT/CT imaging in the same levels who are undergoing open lumbar interbody fusion. New MRI of the lumbar spine and SPECT/CT will be performed 2 years after the surgical procedure. The patients will complete ODI and VAS questionnaires before surgery and at 6- and 24-months follow-up visits. All patients will sign an informed consent form.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Other spinal pathology (tumors, congenital defects, spondylolysis, or spondylolisthesis)
- Intolerance of SPECT examination
- Pregnancy
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 fusionTransforaminal Lumbar Interbody Fusion of the SPECT/CT positive lumbar degeneration | Procedure or surgery | – |
Primary outcome
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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- 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.
Jaroslav Plas contact
Jaroslav Plas study chair
jaroslav.plas@uvn.cz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Back Pain Lower Back Chronic, run by Military University Hospital, Prague at 2 sites in Czechia.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radek Kaiser (+420607545132, rkaiser@hotmail.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (ODI) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.