Degenerative Disc Disease Clinical Trial
Official title:
The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
NCT number | NCT04893720 |
Other study ID # | SPINUS-UVN II |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | June 1, 2026 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 1, 2026 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Military University Hospital Prague | Prague | |
Czechia | University Hospital, Motol | Prague |
Lead Sponsor | Collaborator |
---|---|
Military University Hospital, Prague | University Hospital, Motol |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years | |
Primary | 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). | 2 years |
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