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

3 мая 2026 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Вмешательство/лечение

Подробное описание

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).

Тип исследования

Наблюдательный

Регистрация (Действительный)

50

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

      • Stuttgart, Германия, 70374
        • Sportklinik, Klinikum Stuttgart

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Вероятностная выборка

Исследуемая популяция

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.

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
degeneration of the punctured disc using Pfirrman's classificition
Временное ограничение: 10 years
Ordinal scale of disc deneration with 5 degrees (1=no degeration until 5=complete degeneration of the disc)
10 years

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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.
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Следователи

  • Главный следователь: Andreas Veihelmann, Sportklinik Klinikum Stuttgart

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

15 января 2022 г.

Первичное завершение (Действительный)

1 апреля 2024 г.

Завершение исследования (Действительный)

1 мая 2024 г.

Даты регистрации исследования

Первый отправленный

15 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

3 мая 2026 г.

Первый опубликованный (Действительный)

5 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

5 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

3 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • SRHGBadHerrenalb

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Описание плана IPD

All data can be shared if necessary

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Intradiscal electrothermal Therapy

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