Disc Puncture Does Not Accelerate Degenerative Changes in Lumbar Discs of Patients With Discogeni… (NCT07567404) | Clinical Trial Compass
CompletedNot Applicable
Disc Puncture Does Not Accelerate Degenerative Changes in Lumbar Discs of Patients With Discogenic Pain
Germany50 participantsStarted 2022-01-15
Plain-language summary
Procedures 10 years ago performed included intradiscal nucleoplasty (ACUTHERM) and intradiscal electrothermal therapy (IDET). At follow up MRI scans evaluated by two blinded specialists for disc degeneration were carried out. Intra- and interrater variability were accounted for. Baseline and 10-year post-procedure clinical parameters were compared.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients eligible for early intradiscal procedures included those with low back pain (NRS \> 5) caused by discogenic pain due to disc degeneration or radicular pain due to disc protrusion and subsequent nerve root compression. All patients were required to have been resistant to conservative therapy. Diagnoses were based on patient history, physical examination, imaging studies, and, in some cases, provocative discography if discogenic pain could not otherwise be clearly identified.
Exclusion Criteria:
* • Perioperative complications.
* Post-interventional lumbar spine surgery in the region to be examined.
* Contraindications for a repeated MRI.
* Metastases or infection of the spine since surgery.
* Spinal canal stenosis.
* A diagnosis of anxiety disorder, depression, or somatoform disorder since surgery, based on their medical history.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study looked at whether disc puncture causes additional degeneration in patients with discogenic low back pain — what did the results actually show, and does that change how you think about using needle-based procedures like discography or injections for my situation?
2Since this trial measured disc degeneration using the Pfirrmann classification, can you explain what my current Pfirrmann grade is and whether it puts me in a similar range to the patients studied here?
3The study is now completed — has the data been published anywhere, and if so, would you be willing to review the findings with me so we can talk about what they might mean for my treatment plan?
4Given that this trial focused specifically on discogenic pain, how confident are you that my chronic low back pain is actually coming from the disc itself, and does that affect whether these results are relevant to my case?
5If disc puncture was found not to significantly worsen degeneration, does that make you more or less likely to recommend a diagnostic or therapeutic procedure that involves puncturing my disc, compared to other options we haven't tried yet?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
degeneration of the punctured disc using Pfirrman's classificition