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

3 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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).

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

50

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Stuttgart, Niemcy, 70374
        • Sportklinik, Klinikum Stuttgart

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
degeneration of the punctured disc using Pfirrman's classificition
Ramy czasowe: 10 years
Ordinal scale of disc deneration with 5 degrees (1=no degeration until 5=complete degeneration of the disc)
10 years

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
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.
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Andreas Veihelmann, Sportklinik Klinikum Stuttgart

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 stycznia 2022

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2024

Ukończenie studiów (Rzeczywisty)

1 maja 2024

Daty rejestracji na studia

Pierwszy przesłany

15 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 maja 2026

Pierwszy wysłany (Rzeczywisty)

5 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • SRHGBadHerrenalb

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

All data can be shared if necessary

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Intradiscal electrothermal Therapy

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