Disc Puncture Does Not Accelerate Degenerative Changes in Lumbar Discs of Patients With Discogenic Pain: a Ten-Year Retrospective Observational Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
This retrospective observational cohort study was conducted at a single urban spine department. After obtaining IRB approval from the state medical board (Landesärztekammer Stuttgart, Germany, F-2020-177), all consecutive patients from the outpatient clinic between 2010 and 2013 who underwent intradiscal procedures-such as discography, intradiscal electrothermal therapy (IDET) for discogenic pain, or intradiscal nucleoplasty for radicular pain-were contacted and invited to participate in the study. Participants were asked to undergo a current MRI and complete the patient-reported outcome measures (PROMs) listed below. The study was conducted between 2022 and 2024.
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.
Enrollment Criteria To be included in the retrospective study, patients must have undergone one of the specified intradiscal procedures, successfully established contact, voluntarily agreed to participate, and demonstrated sufficient language proficiency to complete study assessments.
Exclusion Criteria
Patients were excluded if they met any of the following conditions:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •• 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.
研究组 & 干预措施
Intradiscal Procedure
Procedures 10 years ago performed included intradiscal nucleoplasty (ACUTHERM) and intradiscal electrothermal therapy (IDET).
干预措施: Intradiscal electrothermal Therapy (Procedure)
研究者
Andreas Veihelmann
PhD, MD
SRH Gesundheitszentrum Bad Herrenalb