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Disc Puncture Does Not Accelerate Degenerative Changes in Lumbar Discs of Patients With Discogenic Pain

2026年5月3日 更新者:Andreas Veihelmann、SRH Gesundheitszentrum Bad Herrenalb

Disc Puncture Does Not Accelerate Degenerative Changes in Lumbar Discs of Patients With Discogenic Pain: a Ten-Year Retrospective Observational Clinical Study

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.

研究概览

详细说明

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:

  • 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.

Intradiscal Procedures Patients with specific low back pain in this study were treated with minimally invasive techniques prior to considering open surgeries, such as spinal fusion or sequestrectomy. All procedures were performed between 2010 and 2013 by a single spine surgeon experienced in intradiscal interventions. Patients with discogenic pain due to disc degeneration were treated with intradiscal electrothermal therapy (IDET) or nucleoplasty (ACUTHERM) for radicular pain using the NT2000iX generator (Abbott, USA) protocol as described previously (10).

Primary Outcomes The primary outcome of the study was to assess the degeneration of intervertebral discs using the Pfirrmann classification, comparing pre- and postoperative MRI images of punctured and non-punctured discs. Some preoperative MRI images were available from internal archives, while missing images were obtained directly from patients (on DVD) or requested from external radiology centers. Postoperative MRI images were performed in-house and were T2-weighted to ensure consistency and cost efficiency. The Pfirrmann classification, as described by Pfirrmann et al. (11), was used to evaluate intervertebral disc degeneration. This classification involves ordinally scaled stages based on disc structure, nucleus-annulus distinction, signal intensity, and disc height. To improve accuracy, each disc was classified four times in a blinded manner (twice by experienced radiologists and twice by the spinal surgeon). Intra- and interrater reliability was validated using Cohen's kappa and Fleiss' kappa tests, and the mean values of all four assessments were used for analysis.

Comparisons of Pfirrmann values included:

  1. The overall difference in disc degeneration (pre- vs. post-procedure).
  2. Intra-individual comparisons between punctured and adjacent non-punctured discs.
  3. Differences across surgical procedures (discography, IDET, ACUTHERM). To evaluate the impact of varying needle diameters (22-gauge for discography and 17-gauge for IDET/ACUTHERM), discs subjected to both discography and IDET were analyzed within the IDET group.

While the study lacked a true control group, adjacent intervertebral discs in the same patient were used as controls to reduce bias. Randomization was not possible due to limitations in surgical reports, recruitment, and allocation. Therefore, precise intra-individual comparisons were prioritized.

Secondary Outcomes Secondary outcomes included the percentage improvement in Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), and SF-36 Index scores, measured approximately 9.1 years after surgery compared to preoperative values. The NRS asked patients to rate their average pain intensity (back or leg pain) over the previous two weeks on a scale from 0 to 10. The ODI is a self-administered questionnaire measuring "back-specific disability" across 10 items with six response categories each. SF-36 assessed health-related quality of life in areas such as physical functioning, social functioning, and mental health.

To exclude severe changes in biometric data after 10 years we also assessed possible the biometric data at follow up.

Statistical Analysis Data were expressed as mean ± standard deviation (SD) or median with confidence interval (CI). Statistical significance was determined using the Wilcoxon signed-rank test or Mann-Whitney U test, depending on the data distribution and whether samples were paired or independent. Differences between groups were analyzed with the Mann-Whitney U test, with p-values < 0.05 considered significant. Spearman's correlation test assessed relationships between independent variables.

Intra- and interrater reliability for Pfirrmann classifications was evaluated using Cohen's kappa and Fleiss' kappa. The results were interpreted according to Landis and Koch (1977). All statistical analyses were performed using SPSS software (version XX; SPSS Inc., Chicago, IL, USA).

研究类型

观察性的

注册 (实际的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Stuttgart、德国、70374
        • Sportklinik, Klinikum Stuttgart

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Intradiscal Procedure
Procedures 10 years ago performed included intradiscal nucleoplasty (ACUTHERM) and intradiscal electrothermal therapy (IDET).
Intradiscal heating for denervation of nerve ingrowth via flouroscopy

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
degeneration of the punctured disc using Pfirrman's classificition
大体时间:10 years
Ordinal scale of disc deneration with 5 degrees (1=no degeration until 5=complete degeneration of the disc)
10 years

次要结果测量

结果测量
措施说明
大体时间
As secundary outcome pain by numeric rating scale (NRS), oswestry disability index (ODI) and SF-36 which were recorded at baseline and 10 years after intervention.
大体时间:10 years

Pain scale (NRS 0=no pain to 10=worst pain) and general daily activity measurement (ODI, SF-36). The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability). The SF-36 Spine score measures eight distinct domains, often used to determine the Physical Component Summary (PCS) and Mental Component Summary (MCS):

Physical Functioning (PF) Role Limitations due to Physical Problems (RP) Bodily Pain (BP) General Health Perceptions (GH) Vitality/Energy (VT) Social Functioning (SF) Role Limitations due to Emotional Problems (RE) General Mental Health (MH). Each domain is scored from 0 to 100, with 100 representing the highest level of functioning or best health state.

10 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Andreas Veihelmann、Sportklinik Klinikum Stuttgart

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年1月15日

初级完成 (实际的)

2024年4月1日

研究完成 (实际的)

2024年5月1日

研究注册日期

首次提交

2026年4月15日

首先提交符合 QC 标准的

2026年5月3日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年5月3日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • SRHGBadHerrenalb

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

All data can be shared if necessary

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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