Actively Recruiting
Predictive Performance of SPECT/CT Bone Scan Quantification Before Lumbar Arthrodesis Surgery for Chronic Low Back Pain
Led by Central Hospital, Nancy, France · Updated on 2025-01-08
70
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether SPECT/CT bone scan measurements using a CZT solid state camera before surgery can predict good outcomes after lumbar arthrodesis surgery for chronic low back pain. This condition, often resistant to medical treatment, involves fusing adjacent vertebrae to relieve pain and improve function. The study explores if a specific bone scan value, SUVmax, correlates with improvements measured by the Oswestry Disability Index (ODI) and numerical pain scale after surgery. Participants who will undergo lumbar arthrodesis surgery performed by experienced neurosurgeons will receive a bone scan before their operation. The surgery targets up to two spinal levels using standard techniques. Patients will complete pain and disability questionnaires before and after surgery to assess changes. The bone scan results will be analyzed to see if they can identify patients who respond well to the surgery. During the study, participants will be monitored through questionnaires assessing pain and disability over 24 months. Researchers will evaluate the correlation between the bone scan SUVmax value and surgical outcomes based on the ODI. The study excludes patients with neuropathic pain or other spine conditions and includes safety monitoring for radiopharmaceutical allergies and ability to remain still during scans. This research aims to improve preoperative selection of patients likely to benefit from lumbar fusion surgery.
CONDITIONS
Official Title
SPECT/CT Bone Scan Quantification Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Back pain lasting at least 3 months, likely due to degenerative disc disease or spondylolisthesis
- Age 18 years or older and able to understand study information
- Affiliated with a social security scheme
- Scheduled for lumbar arthrodesis surgery involving up to two spinal levels
- Surgery performed by one of three senior neurosurgeons at Nancy CHRU using similar techniques
You will not qualify if you...
- Neuropathic low back pain with a Neuropathic Pain Scale score of 4 or higher
- Previous lumbar spine surgery
- Other spine-related conditions causing pain, including multistage discopathies, ankylosing spondylitis, spondylodiscitis, rheumatoid arthritis, vertebral compression, vertebral metastasis, narrow lumbar canal, scoliosis, and spondylolisthesis by isthmic lysis
- Pregnancy, nursing, or women of childbearing age without proper contraception
- Unstable medical condition or inability to stay still lying down during scans
- Allergy to the radiopharmaceutical TECHNESCAN HDP
- Persons restricted by law or under psychiatric care as specified by public health codes
- Adults unable to express opposition to participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nuclear Medicine Department
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
Research Team
A
Achraf BAHLOUL, MD
V
Véronique ROCH, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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